Laurie Auerbach


Consultant


Results-driven professional with solid project management, technical and compliance knowledge, skilled in quality systems implementations, change controls, supplier management, inventory management, production and process controls, and regulatory affairs. Broad experience working for top global pharmaceutical, medical device, in vitro diagnostic, combination product, and biologics manufacturers. Background in coagulation disease therapeutics, transdermal products, blood gas and electrolyte analyzers, molecular diagnostic assays for infectious disease and inherited disease, coagulation antibody diagnostic assays, epinephrine injectors, obstetric and gynecological devices, fluorescent sensor chemistry, multi-channel injection molded platforms for assay delivery, LED optical reflectance technology, lyophilization, IVD equipment and reagent filling processes.

CORE COMPETENCIES

  • Project Management/Leadership
  • Supplier Management/Material Controls
  • Technology Transfer/Design Transfer
  • Change Control/Document Control
  • Packaging and Labeling Controls
  • Raw Material Qualification
  • Risk Management/Hazard Analysis
  • Stability Protocols/Reserve Sample Programs
  • Operating Procedures/Work Instructions
  • Inspection Procedures/Test Methods
  • Sampling Techniques/Sampling Plans
  • Design Controls/Design History Files
  • Computer Systems Implementation
  • Laboratory Controls/LIMS
  • Inventory Management/ERP
  • DHF Remediation/Gap Analysis
  • Production/Process Controls
  • Quality Assurance/Regulatory Affairs
  • Design Controls/Outputs/Reviews
  • Design Verification/Validation
  • Traceability Matrices
  • Quality Systems Development/Support/Auditing
  • Training/Training Materials/Assessments
  • 21 CFR Parts 4/11/210/211/801/803/820
  • Council Directives 93/42/EEC; 98/79/EC
  • Device Software Validation/IEC 62304
  • Canada Medical Devices Regulations
  • ISO 9000/ISO 13485/ISO 14971/ISO 17025

SELECTED ACCOMPLISHMENTS

  • Developed Design Control process and conducted training for an IVD manufacturer of molecular diagnostic systems, including:
    • Led 10-week effort with four (4) business units/contract manufacturers to establish harmonized design control approach
    • Established phase gate process for a molecular diagnostics platform consisting of lab instrumentation, device software, consumables and reagents, including phase exit requirements, roles, responsibilities and required deliverables for each phase
    • Helped establish and document a device software development life cycle (SDLC) using Agile methodology while ensuring compliance with IEC62304
    • Created governing design control and risk management quality policies in compliance with ISO 13485, ISO 14971, 21CFR Part 820, IEC 62304, and Council Directive 98/79/EC
    • Established DHF electronic binder templates and metadata requirements for assay product development projects including phase review checklists, design review templates, risk management templates, design inputs and output templates, traceability matrix, design verification and validation templates, and technical report templates.
  • Managed change control activities for a global “virtual” biopharmaceutical manufacturer of over 30 commercial and developmental pharmaceutical and nutraceutical products (mental health, respiratory, dermatology, urology, obstetrics, inflammatory disease, and cardiology) with outsourced manufacturing operations, laboratory testing and distribution at a total of 41 supplier locations and 34 unique suppliers, including:
    • Led review and closeout (where applicable) of backlog of 50+ change controls from contract manufacturers and laboratories completed by team of 2 FTE’s in two (2) weeks.
    • Oversaw subsequent project to initiate and drive to completion 38 of these changes in OEM quality system. Responsibilities included:
      • Project Management – determined critical path to ensure changes were implemented on time; managed timeline, milestones and resource allocation using Microsoft Project; served as liaison between all impacted functions including CMO Operations, Materials Management, Regulatory, Logistics, Warehouse, and Purchasing; mitigated and communicated any risks to minimize customer impact and delays; communicated project status and changes to stakeholders
      • Managed coordination and completion of associated implementation activities including:
        • Supplier Management – RFI/RFQ; COG Analysis; Capability Analysis; Supplier Qualification (Surveys, Onsite Audits, Manufacturing and Quality Agreements, First Article Inspections), Establishing Inspection and Sampling Plans; technology transfer to new suppliers and/or sites;
        • Inventory Management – BOM creation/updates, Master Work Order Creation/Updates; Material disposition of Raw Materials, Intermediates, Finished Goods and WIP; Rework Orders;
        • Distributor Management – Agreement creation/updates; Issuance of Technical and Customer bulletins;
        • Stability and Reserve Sample Program changes – Stability protocol changes, environmental chamber validations, inventory updates;
        • Raw Material Qualifications – Establishing and documenting release criteria for new suppliers and lots of critical raw materials, inventory cut-in, scrap control and rework;
        • QC Test Method Changes – Compendial updates; Test method transfers and validations; Reference standard changes;
        • Labeling and Artwork Changes – Coordinate with printing vendors, copy approval, inventory reconciliation (e.g. Scrap, Lot # cut-ins); regulatory agency approvals, language translation verification, barcode verification, labeling validation;
        • Packaging Changes – Bioburden testing; Packaging automation process changes and validation, ISTA testing, Shipping studies
      • Examples of Change control projects include:
        • Lead effort to review and update all applicable Raw Material Test Reports (RMTR) for five (5) product lines to ensure test methods and specifications aligned with current compendial and in-house developed test methods to be performed by three (3) different contract laboratories. Implementation of change control resulted in updates to 40+ RMTR’s, 18 Test Methods, completion of three (3) test method transfers, and five (5) test method validations.
        • Managed OEM change control for line extension of prescription topical lotion to add a new bottle size and change packaging design. Implementation activities included qualification of new suppliers, qualifying new bottle size, filling and packaging validation, developing and approving new labeling and artwork (primary and secondary labels, patient information leaflets), labeling validation, ERP updates – creation or revision of BOMs, SKU’s, and Master Work Orders; batch record updates, creating packaging material inspection plans, shipping studies, stability testing, and submission and approval of a CBE-30 with the FDA.
        • Managed OEM change control to add French labeling for distribution of prescription prenatal supplements in Canada. Change control activities included translation of all applicable labeling into French including Patient Information leaflets, carton and bottle artwork, and print mats for blister packs; coordinating artwork changes with printing vendors; execution of distributor agreements; labeling and translation validation; barcode verification; ERP updates, Creation of BOM, SKU’s, and Master Work Order; obtaining required regulatory approvals.
  • Led project to eliminate two (2) year backlog of open discrepancy and non-conformance reports changes for a global biopharmaceutical manufacturer of 18 outsourced commercial prescription and OTC pharmaceutical products.
    • Responsible for conducting investigations, performing root cause analysis, risk assessments, product disposition, and CAPA initiation where applicable, resulting in closeout of over 200 reports in three (3) months
    • Investigated 80+ OOS Stability results for marketed drugs resulting in 13 field alerts and two (2) product recalls
    • Compiled annual product trending reports on 12 drugs for a two (2) year period and presented to corporate executive management to serve as input for operational process improvement changes.
  • Conducted a comprehensive audit of manufacturing and laboratory operations for compliance with 21 CFR Parts 210 and 211 for a large active pharmaceutical ingredient manufacturer. Based on findings made recommendations that led to:
    • Creation of a validation department;
    • Development and automation of a global change control process through implementation of TrackWise, and;
    • Implementation of an inventory management system
  • Conducted a gap assessment of a chemical testing lab of a global combination product manufacturer of implantable products for cardiovascular therapy for compliance with pharmaceutical regulations including:
    • Performed a gap analysis of SOPs and business processes against ISO17025, 21 CFR Part 211 and 820, start/stop analysis of current projects, 5-year project and IT systems roadmap, and implementation support requirements
    • Created a matrix outlining the differences in the drug and device regulations for each applicable quality system to determine the requirements of each constituent part
    • Results highlighted more stringent pharmaceutical requirements for chain of custody, OOS, data management, test method validation, and materials management than medical device requirements
    • Provided recommendations for quality system improvements, including re-engineering of business processes and implementing automation systems to focus on meeting compliance needs for combination products (prior to FDA guidance on combination products)
  • Established the complete supply chain lifecycle process for a medical device manufacturer of a Class III non-invasive cervical neoplasia detection system including developing the following sub-processes and procedures:
    • Sales order processing and production planning including receipt and creation of customer purchase orders, production forecasting, master work order creation and management;
    • Supplier management program including RFI/RFQ, transfer and management of outsourced processes, supplier qualification process (risk assessment, capability analysis, pilot production and validation runs, survey and audit program, first article inspections, raw material qualifications), supplier performance reviews, approved vendor list management;
    • Purchasing process including Engineering and Production purchase order process, PO change control, purchasing and manufacturing terms and agreements, purchased material classifications;
    • Inventory management including creating a manual system for control of 450+ unique part numbers and 30+ product SKU’s to include BOM Management, stock quantities and status, and supplier information, scrap control, rework orders;
    • Management of acceptance activities including first article, incoming, in-process, and finished goods receipt, inspection and release;
    • Warehouse management including receipt of goods, handling and storage of materials to ensure segregation by status and to meet shelf-life requirements, environmental and contamination controls, FIFO, expiry date management, shipping and export requirements, and inventory reconciliation;
    • Distributor management including distributor selection criteria, distributor agreements, determining country of distribution requirements, distributor training
  • Served as supplier quality lead on product development team for a medical device manufacturer of a Class III non-invasive cervical neoplasia detection system utilizing biophotonic technology, including:
    • Managed first article inspection for backlog of 400+ machined, injection molded, electrical, optical, hardware, packaging and labeling materials eliminating existing backlog in three (3) months
    • Led supplier qualification efforts for 40+ suppliers including performed critical supplier audits for fiberoptic, reference target material, and single use disposable suppliers, created quality agreements, performed risk assessments to determine supplier monitoring requirements, performed SPC analysis on inspection data, and established incoming inspection criteria
    • Reviewed all packaging and labelling specifications for compliance with 21 CFR Part 801, 93/42/EEC (MDD), Canada Medical Devices Regulations (CMDR), ISO 15223, ES 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366, and ISTA
    • Reviewed all packaging and labelling specifications for compliance with 21 CFR Part 801, 93/42/EEC (MDD), Canada Medical Devices Regulations (CMDR), ISO 15223, ES 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366, and ISTA
    • Revised all quality system procedures and created new procedures in preparation for ISO 13485 certification to include removal of references to legacy products and processes, regulatory updates, alignment of design control and risk management requirements for Class III medical devices, and establishment of defect classifications and AQL levels for purchased product
    • Served as management representative for ISO 13485 certification audit resulting in no non-conformances
  • Led Change Review Board (CRB) for multiple product development and technology transfer projects for a manufacturer of blood gas and electrolyte analyzers and consumables including:
    • For a line extension of an existing electrolyte analyzer and consumables, established and drove the required changes and activities for the addition of a Lactate sensor including stability testing, packaging validation, algorithm verification, and change control of over 50 impacted documents, resulting in 510K approval (K093280) and an on-time product launch.
    • Facilitated activities required to transfer the manufacture of fluoroionophore, the critical component used to manufacture electrolyte sensors, to a contract manufacturer. Responsibilities included assisting with capability analysis and onsite compliance audit of contract manufacturer to ensure continuity of supply chain to meet customer demand; review and approval of contract manufacturer’s raw material suppliers; managed transfer of test methods for incoming, in-process, and final release testing; oversight of pilot run and scale up studies to establish in-process and final release specifications; review and approval of batch manufacturing instructions; managed the raw material qualification of first three (3) lots received, established incoming inspection and release criteria, and implemented inspection plans. Transfer was completed for two (2) different sensors in six (6) months reducing production backlog by 75% and decreasing Sensor chemistry operations overhead cost by 35%.
  • Served as core team member on project team for development of a genetic analyzer system for Laboratory Developed Testing (LDT) for an IVD manufacturer. Responsible for oversight and/or execution of the following QA activities:
    • QA Reviewer and/or Approver on all required DHF project deliverables
    • Ensured design control requirements were met for the product development of:
      • Consumable cartridge with semi-conductor chip for sample management and assay performance using PCR (Polymerase Chain Reaction) and HRM (High Resolution Melt) technologies
      • Assay panel for detection of four (4) coagulation disease related mutations
      • Benchtop instrument and system software for delivery of assay reagents on cartridge, regulation of PCR and HRM cycles, and results display and analysis
      • Melt analysis software for sample genotyping
    • Worked with critical suppliers to establish release criteria, quality system requirements in compliance with 21CFR Part 820 and ISO13485, and quality agreements
    • Resolved quality issue of cross-well contamination in assay plates resulting in change in filling specifications.
    • Authored Quality Plan, Master Validation Plan, Supplier Qualification Plan and performed DHF Audits
    • Helped establish assay design inputs for stability, contamination, packaging, and performance
    • Developed strategy for assay and cartridge stability, packaging, transport, and storage testing in accordance with FDA requirements, BS EN 13640, and ISTA standards

PROFESSIONAL EXPERIENCE

  • QSN Consultant, 4/16 – Present
  • Canon U.S. Life Sciences, Inc., Senior Manager, Quality Systems, 7/12 – 10/15
  • Guided Therapeutics, QA/QC Manager, 5/11 – 6/12
  • Shionogi Pharmaceuticals., Senior Quality Assurance Consultant, 1/11 – 5/11
  • OPTI Medical, Quality Assurance Manager, 9/08 – 1/11
  • Life Therapeutics, Quality Assurance/Regulatory Affairs Manager, Manufacturing, 8/07 – 9/08
    • Clarkston Consulting, Life Sciences Consultant, 5/05 – 8/07
    • Gen-Probe, Validation Manager, 3/07 – 8/07
    • GE Healthcare, Validation Manager, 10/06 – 2/07
    • Stiefel Pharmaceutical, Organizational Development/Change Management, 8/06 – 9/06
    • Medtronic, Quality Assurance Strategy, 7/06 – 8/06
    • Chiron, Quality Assurance Strategy, 4/06 – 7/06
    • Shire Pharmaceuticals, Quality Assurance Strategy, 3/06 – 4/06
    • Boehringer Ingelheim Pharmaceuticals, Inc., Quality Assurance Strategy, 10/05 – 2/06
    • Boehringer Ingelheim Chemical, Inc., Validation Lead, 5/05 – 9/05

EDUCATION

  • Master of Science, Anatomic Pathology, University of Maryland School of Medicine, 5/96
  • Bachelor of Science, Biology, Ursinus College, 5/93

TRAINING

  • Management Essential Skills, Canon, 9/14
  • Application of Agile Practices in the Development of Medical Device Software, AAMI, 5/14
  • Design Control Concepts and Implementation, Oriel Stat-a-Matrix, 10/12
  • Risk Management and Analysis for Medical Devices, Oriel Stat-a-Matrix, 10/12
  • Understanding Basic and Statistical Process Control, Global Compliance Panel, 9/11
  • Technical Documentation Requirements for Device Approval in EU, TUV SUD America, 8/11
  • RoHs 2 – Compliance with the New RoHS Directive, Intertek, 7/11
  • DHF, DMR, DHR, Technical File and Design Dossier – Key Requirements and Future Directions, Global Compliance Panel, 6/11
  • Medical Device Recalls, First Quality, Inc., 6/11
  • Risk-based Validation Master Plan for a GMP facility, Medmarc, 6/11
  • Process Improvement with Statistical Process Control, Quality Assurance Solutions, 6/10
  • Creating Simple, Defensible Documentation to Prove FDA Compliance, Compliance Alliance, 9/09
  • The Art of Communicating with Tact and Skill, Dale Carnegie, 6/09
  • ISO 13485 Internal Auditor, Oriel Stat-a-Matrix, 5/07
  • ISO 19011 Auditing Fundamentals, ASQ, 3/07
  • Achieving Success Through Human Relations Skills, Dale Carnegie, 1/07
  • Business Consulting, Clarkston Consulting, 5/06
  • Process and Equipment Validation, Clarkston Consulting, 3/06
  • 21 CFR Part 11 and Computer Systems Validation, Clarkston Consulting, 6/05
  • Basic Principles of Computerized Systems Compliance Using GAMP4, ISPE, 6/05

AFFILIATIONS

  • American Society for Quality (ASQ) (Member #64102800) – 10/07 – Present
  • Regulatory Affairs Professionals Society (RAPS) – 10/12 – Present

Jitendra J. Balar


Consultant


Professional with years of experience, skilled in analytical chemistry, quality control, quality assurance, quality systems, and regulatory affairs. Highly credentialed and experienced in medical device, drug, and fine chemicals manufacturing industries. Background in needle and infant security device products, diagnostic equipment components, and fine chemicals.

CORE COMPETENCIES

  • Quality System Development/Support/Auditing Business Continuity Process
  • Quality Control/Quality Assurance Supply Chain/Procurement
  • Design Control Training/Training Material/Assessments
  • Change Management/21 CFR Part 820
  • Risk Management/FMEA/Hazard Analysis ISO 9000/ISO 13485/ISO/TS 16949
  • Operating Procedures/Work instructions Process Improvement/Six Sigma

SELECTED ACCOMPLISHMENTS

  • Developed quality management systems for compliance with 21CFR Part 820 and ISO13485, and managed various activities for medical device manufacturers of needle and infant security device products, and components of diagnostic equipment, including:
    • Performed gap analyses to identify compliance issues, elevating critical concerns to executive management for quality planning purposes
    • Developed project plans to prioritize compliance initiative activities and implement associated corrective actions
    • Developed quality manuals, standard operating procedures, and other required documents for compliance with applicable regulations and standards
    • Supported risk management activities according to ISO 14971, developed associated training material, and provided training for conducting FMEA’s
    • Developed training packages for ISO 13485 requirements, carrying out in-depth training to address CAPA and customer complaints
    • Conducted precertification audits to assess readiness and prepare companies for ISO certification, providing guidance on how issues may be addressed
    • Performed internal audits to ensure overall system compliance with applicable standard operating procedures and work instructions
  • Developed processes for chemical manufacturer to analyze drugs in support of pharmaceutical R&D and manufacturing activities, including:
    • Developed analytical processes using various instrumental techniques
    • Analyzed various drugs using USP methodologies
    • Performed quality assurance services by inspecting, performing process audits, and assisting with corrective action requests
    • Conducted supplier audits at pharmaceutical raw material manufacturing and packaging vendors
  • Provided services to assess training requirements for various manufacturing organizations, including:
    • Completed needs assessments for human resource departments to identify training needs for personnel and overall departments
    • Developed training materials that considered position of employees and organization’s culture
    • Conducted training to include ISO requirements, internal auditing, SPC, time management, conducting meetings, presentation skills, diversity, etc.
  • Developed business continuity management processes for vendors of global chemical manufacturing company, including:
    • Developed processes to identify and define critical suppliers
    • Prioritized suppliers based upon criticality and prepared schedules for visiting sites and performing required gap analysis
    • Conducted gap analyses for Asian, European, and US suppliers
    • Prepared training manuals and worked with suppliers regarding business planning processes and appropriate methods for responding to business interruptions
  • Reduced cost and improved organization’s supply chain and inventory management processes, including:
    • Analyzed raw materials inventory at each Asian, European, and US manufacturing plant
    • Determined cycle time for each product and established raw material procurement and inventory policy to reduce carrying cost of raw material inventory by 40%
    • Worked with suppliers to improve on-time delivery and reduced raw material inspection frequency
    • Improved internal processes to reduce manufacturing cycle time
    • Established key performance indicators to monitor progress over time

PROFESSIONAL EXPERIENCE

  • Balar Quality Systems, LLC, President and Principal Consultant (Washington, NJ) – 7/07 to Present
  • Hoechst AG/AZ EM, Director, Global Procurement/Risk Assessment (Branchburg, NJ) – 2/06 to 4/09
  • Hoechst AG/AZ Electronic Materials, Director of Quality (Branchburg, NJ) – 1/99 to 2/06
  • Hoechst AG/Clariant, FAB Manager (Branchburg, NJ) – 5/97 to 1/99
  • Hoechst AG, Materials Manager (Branchburg, NJ) – 5/96 to 4/97
  • Hoechst AG, QA/Analytical Department Manager (Coventry, RI) – 6/89 to 5/96
  • Hoechst AG, QC/QA Manager (Coventry, RI) – 1/85 to 6/89
  • Hoechst AG, Sr. Analytical Chemist/R&D Manager (Coventry, RI) – 7/73 to 1/85
  • Yale New Haven Hospital, Clinical Chemist (New Haven, CT) – 3/72 to 6/73
  • American Cyanamid, Analytical Chemist (Stamford, CT) – 8/69 to 11/71

EDUCATION

  • Master of Science in Total Quality Management, Anna Maria College, MA – 5/95 to 5/96
  • Master of Science in Organic Chemistry, Southern Connecticut University, CT – 9/71 to 12/72
  • Master of Science in Inorganic Chemistry, Gujarat University, India – 5/66 to 4/68
  • Bachelor of Science in Chemistry, Gujarat University, India – 5/62 to 5/66

CERTIFICATION

  • Certified Lead Quality Auditor ISO 9001 and ISO 13485 (QMS), RABQSA – 2/04 to Present
  • Certified Business Continuity Planner, Business Continuity Institute – 12/10
  • Certified Green Belt, AAA – 6/08

TRAINING

  • Risk Management/Analysis for Medical Devices/Pharma. Industries Overview (ISO 14971) – 12/12
  • IEC 60601-1:2005, Amendment 1 – 11/12
  • ISO 13485:2003 Auditor Training – 12/11
  • Business Continuity Planning, Business Continuity Institute – 12/10
  • Six Sigma Black Belt Training – 6/08
  • Sr. Management Leadership Program – 6/04
  • Dr. Deming’s Quality Improvement Seminar – 5/94
  • Dr. Juran’s Problem Solving Training – 4/90

AFFILIATIONS

  • Business Continuity Institute, Associate Membership – ended 12/12
  • American Society of Quality, Vice Chair/Executive Board Member (Princeton, NJ Chapter) – 1/05 – 12/08
  • American Society of Quality, Sr. Member (Member #00149195) – 7/89 – Present

Jaclyn Budreckis


Consultant


Talented, innovative, and energetic professional with solid quality engineering and process improvement expertise. Highly credentialed with years of experience working with leading, global medical device and biotechnology manufacturers. Background in needles, syringes, blood glucose meters, filters, drug eluting/bare stents, catheters, guide wires, biopsy forceps, hydrothermal ablation and pelvic floor products.

CORE COMPETENCIES

  • Quality Engineering Methods/Tools
  • Statistical Analysis/Methods/Tools
  • Sampling Plans/Rationale
  • Risk Management/Risk Analyses
  • Design Controls/DHF Documentation
  • Production/Process Controls
  • Process Improvement
  • Training Programs
  • Quality System Development
  • Procedural/Work Instruction Development
  • Auditing/Gap Analyses
  • Quality System Compliance
  • Root Cause Investigation/Analysis
  • Cost Reduction/Waste Reduction
  • Acceptance Activities/Test Methods
  • 21 CFR Part 820/ISO 13485/ISO 14971

SELECTED ACCOMPLISHMENTS

  • Provided leadership and technical expertise for project dedicated to complete re-engineering of risk management system for global medical device company including software solution, policy, procedures, work instructions, and training, resulting in streamlined risk management system that focused on patient safety and shared risk information across related product lines
  • Contributed to development of design control training for global medical device company and participated in delivery of said training resulting in current, compliant, and consistent design control practices across organization
  • Participated in project to remediate all historical process validations performed by global medical device company resulting in identification and mitigation of gaps
  • Developed and delivered technical training on various statistical techniques within several global medical device companies resulting in increased data driven decision-making across multiple functions
  • Lead process characterization studies for global biotechnology support company resulting in more in depth understanding and tighter control of process parameters
  • Developed and implemented method for identifying out of control process conditions needing further investigation prior to product release to global biotechnology company resulting in increased customer satisfaction and closure of audit findings
  • Performed detailed gap analysis to identify where manufacturing practices differed from standard operating procedures and mitigated said gaps resulting in compliant practices and procedures
  • Developed Six Sigma Program for global medical device company complete with rollout strategy, training curriculum, training schedule, project selection strategy and project definition guidelines
  • Identified dimensions that significantly contributed to function of medical device product resulting in reduction in number of dimensions considered critical and requiring measurement by 67%
  • Implemented test fixture and method improvements for global medical device company resulting in significantly improved gage repeatability and reproducibility
  • Streamlined sterility testing process of global medical device company for quarterly dose audits resulting in 60% reduction in turnaround time
  • Identified root cause Bacteriostasis/Fungistasis testing failures for global medical device company resulting in increased success rate from 0 to 100%
  • Revised global medical device company’s corporate microbiology department’s controlled documentation system resulting in elimination of 39% of documents
  • Identified wasteful practices used to perform gel clot Limulus Amoebocyte Lysate Assay at global medical device company resulting in reduction of materials and reagents required to perform assay by 80% for annual savings of $255,000
  • Implemented new semi-automated turbidametric method for Limulus Amoebocyte Lysate Assay for global medical device company resulting in increased throughput, faster turnaround time, and reduction in materials and reagents required
  • Identified root cause Ames Mutagenicity Testing failures resulting in increased success rate from 0 to 100%

PROFESSIONAL EXPERIENCE

  • Budreckis Quality Engineering, LLC – 5/12 to Present
  • Boston Scientific, Principal Quality Engineer – 5/08 to 1/12
  • Boston Scientific, Manager I – 4/07 to 5/08
  • Boston Scientific, Principal Quality Engineer – 10/06 to 4/07
  • Boston Scientific, Senior Quality Engineer – 11/05 to 10/06
  • Millipore Corporation, Quality Engineer III – 6/04 to 11/05
  • Abbott Laboratories, Design Control Specialist – 12/02 to 6/04
  • Tyco Healthcare, Quality Engineer – 2/02 to 12/02
  • Tyco Healthcare, Microbiology Supervisor – 10/99 to 2/02
  • Tyco Healthcare, Toxicology Technologist – 10/97 to 10/99
  • Massachusetts Institute of Technology, Research Technologist – 10/96 to 8/97

EDUCATION

  • Graduate studies, Biology, Northeastern University – 9/94 to 9/96
  • BS, Marine Biology, Long Island University – 8/93

CERTIFICATION

  • Six Sigma Black Belt, Tyco Healthcare – 11/02
  • Quality Engineering (CQE), American Society for Quality (ASQ) – 12/01

TRAINING

  • Global Approaches to Risk Management throughout Product Life Cycles, AdvaMed – 5/07
  • Leading and Implementing Change Without Pain, Pervasive Learning Solutions – 5/07
  • Risk Management in Operations, ASQ Biomedical Division – 2/07
  • Risk Management, Regulatory Affairs Professional Society – 12/06
  • Risk Assessment and Management, Institute of Validation Technology – 6/06
  • Gamma Radiation Sterilization, PTi international – 3/05
  • Internal Customer Service, Millipore – 10/04
  • Basic Statistical Process Control, Worcester Polytechnic Institute – 9/04
  • Introduction to GMPs and Good Documentation Practices, QCT Solutions, LLC – 8/04
  • Creating a Workplace of Champions, Millipore – 8/04
  • Product Design for Six Sigma, Breakthrough Management Group – 1/04
  • Operation and Maintenance of Tangential Flow Filtration Systems, Millipore – 6/04
  • Six Sigma Train-The-Trainer, Breakthrough Management Group – 12/03
  • Six Sigma Transactional ToolMaster, Breakthrough Management Group – 11/03
  • Six Sigma ToolMaster, Breakthrough Management Group – 10/03
  • Design Control Requirements & Industry Practice, AAMI – 9/03
  • Software Validation, ASQ Biomedical Division – 6/03
  • Six Sigma, Tyco Healthcare – 2/02
  • Validation Fundamentals, Validation Technologies, Inc. – 11/01
  • Taking Corrective Action, Tyco Healthcare – 8/01
  • Coaching for Optimal Performance – 8/01
  • Internal Auditor, Tyco Healthcare – 5/01
  • Cost System, Tyco Healthcare – 5/01
  • Dealing With Emotional Behavior – 5/01
  • Recognizing Positive Results – 5/01
  • ISO 9002 Refresher, Tyco Healthcare – 5/01
  • Respect in the Work Place, Tyco Healthcare – 2/01
  • Hazard Communication, Tyco Healthcare – 11/00
  • Personal Strategies for Navigating Change, Tyco Healthcare – 11/00
  • ISO, Tyco Healthcare – 11/00
  • Giving Constructive Feedback, Tyco Healthcare – 8/00
  • Getting Good Information From Others, Tyco Healthcare – 8/00
  • Behavioral Interviewing, Behavioral Technology™ A Provant Company – 8/00
  • ISO 9002 Train-The-Trainer, Tyco Healthcare – 4/00
  • Basic Supervisor Skills, Embry-Riddle Aeronautical University – 2/00

Erik Christie


Consultant


Pharmaceutical Professional with over 20 years of solid technical and compliance knowledge in all aspects of manufacturing, cGMP compliance, regulatory compliance, validation, equipment validation ( including tablet presses and coaters, granulation equipment, liquid fillers, high shear mixers, PLC, and SCADA), sterile processes, quality assurance, gaps in processes and procedures, packing configuration, temperature controlled shipping, cold chain procedures, global shipping protocols, Experience working in top global pharmaceutical and biologics manufacturing companies. Background in vaccines, live virus vaccines, liquid pharmaceuticals and sprays, tablets, generics, dosage variations, antacids, excipients, oral disbursables, and combination products.

CORE COMPETENCIES

  • Risk Management/FMEA/SWIFT Assessments
  • Factory Acceptance Testing/Site Acceptance Testing
  • Commissioning and Qualification
  • IQ, OQ and PQ, Generation/Execution
  • SOP Development and Generation
  • Equipment and CSV (Enterprise/Automation) Validation
  • Process/Utility/CIP and SIP Validation
  • Building Automation Systems (BAS/BMS)
  • Temp/RH Studies (Chambers, Warehouse, Transportation)
  • Installation of Temp Monitoring Systems
  • 5 S / Kaizen / Kanban / Right the First Time (RTF)
  • Change Initiatives/Change Controls
  • Quality System Development/Support/Auditing
  • Training/Training Materials/Assessments/Facilitation
  • FDA regulations, ICH Guidelines Q Series, PDA Technical Reports, GAMP5, ASTM E2500
  • Site and Global Project Implementation Experience
  • Electronic Document Systems (Trackwise/Documentum)
  • 100% Completion Metrics (Time/Budget/Resources)
  • CAPA, Deviation and Non-Conformance Reporting Quality Assurance/Regulatory Affairs
  • Project Management/Leadership

SELECTED ACCOMPLISHMENTS

  • Consent Decree CSV Remediation project activities for an OTC product manufacturer, including:
    • Provided Consent Decree Step Lead project management. Activities included the targeted remediation of all computer system (CSV) related equipment on the manufacturing site (Fill/Finish/Packaging).
    • Remediation of liquid, solid and packaging lines (CSV equipment automation and site enterprise systems), including gap assessments and summary reports, change controls, quality risk management documentation, functional/user requirements, protocol generation and execution, traceability matrices and final verification with third party auditor. Leadership activities included, document matrices, coordination with site base business and CD management coordination of timeline, resources and deliverables.
  • Pilot Plant Start-Up Qualification and Validation activities for an OTC product manufacturer, including:
    • Provided senior level consulting for new R&D pilot plant start-up.
    • Participated in Factory Acceptance Testing and Site Acceptance Testing for solids and liquids processing, USP water system, clean steam generation and utility systems.
    • Prepared and executed Installation, Operational (IOQ) and Performance (PQ) documentation for new solids processing equipment and USP water system.
    • Equipment validation included mixing, blending and granulation equipment, tablet presses, tablet coater, scales, liquid filler, glass washer and laboratory equipment. Water system consisted of generation and distribution.
    • Utility validation included compressed air system, steam generator, HVAC system and building automation system upgrades.
  • Global shipping qualification responsibility efforts for high-profile pharmaceutical, manufacturer of generic products, including:
    • Designed, implemented and executed a Cold Chain Shipping Qualification for worldwide product distribution (+200 products, Temperature Ranges of -80°C, -25°C and 2-8°C).
    • Generation of Validation Master Plan, protocols, risk assessments, SOP’s and reports to qualify the shipping of temperature controlled product from bulk manufacturing site to the filling and packaging site to the distribution site to the final customer.
    • Designed and executed packing configuration and coordination of global shipping protocols.
    • Efforts included; warehouse thermal mapping, packaging thermal studies, thermal shipping studies and datalogger/testing equipment management.
    • Revision of all concurrent SOP’s concerning the temperature stability of product from storage, manufacture and distribution.
    • Revision and implementation of cold chain procedures for manufacture storage and global distribution of temperature sensitive product.
    • Protocols and documentation were executed across multiple sites and multiple products, including facilitation of meetings with thermal qualifications in UK, Canada, and Japan, preparation of minutes to track action items, mitigation of risks to project timelines, and reporting of progress and risks to upper management.
  • Processing validation responsibility efforts for high-profile pharmaceutical, manufacturer of vaccine products, including:
    • Participated in the design, coordination, and timely execution of multiple simultaneous validation studies for new and existing equipment for the manufacture and release of commercial and clinical vaccines.
    • Assisted with assessment of equipment systems via P&ID Walk-Down.
    • Provided support for commissioning of equipment during the new vaccine campaigns; IOQ, PQ and final report preparation.
    • Validation execution of SIP/CIP sterile processes and new cleaning paths.
    • Participated in validation of equipment automation; PLC and SCADA.
  • Senior Consulting responsibility effort for a high-profile pharmaceutical, manufacturer of vaccine products, including:
    • Generation of new corporate Quality System Element for Validation.
    • Performed gap analysis and quality risk assessments of current systems.
    • Remediated risks through new corporate guidelines and procedures.
    • Coordinated with other Quality System leaders for formal QSE rollout of new global Quality Systems
    • Prepared quality documents including procedures, SOP’s and work instructions for corporate and site validation efforts and activities.
    • Worked with Global Engineering on the development of the Installation, Commissioning and Qualification program (ICQ), developing the procedural documents for Requirements Specifications, Acceptance Testing, Installation Verification and Installation Qualification. Developed multi-site procedures and work instructions for Computer System Validation, Supplier Auditing and Risk Assessments in line with GAMP5 recommendations.
    • Worked with necessary stakeholders, including business process owners, site validation and quality, to ensure that methodologies to ensure new quality system met all GMP requirements and other quality standards.
  • Senior Training responsibility effort for a high-profile pharmaceutical, manufacturer of vaccine products, including:
    • Provided support for Corporate Training Strategy and Organizational Effectiveness
    • Developed approaches and methodology for new global training projects.
    • Prepared and developed on-site and off-site training curriculum.
    • Managed the delivery of course materials through direct oversight of course creation, assessing stakeholder needs, tracking performance metrics and performing issue resolution.
    • Supported off-site communication of corporate training strategy to upper management and site level leaders
    • Reduced new employee on boarding time by developing and streamlining training programs to focus on customer value added requirements.
    • Created and optimized training curriculum; including instructional design of Instructor Lead and Computer Based Training.
    • Facilitated training curriculum including employee assessments.
    • Assisted with the creation of a new, more rigorous validation training program with an emphasis on GMP and validation procedures and application of validation concepts; thereby significantly improving the training metrics and validation activity success rate.
    • Supported global LIMS training implementation on time and budget
  • Senior Validation responsibility efforts for a high-profile pharmaceutical, manufacturer of vaccine products, including:
    • Championed equipment qualification activities, i.e. Installation, Operation, and Performance qualification execution, deviation assessments and report development.
    • Provided technical support for the manufacture of cell-culture based live virus vaccines. This included equipment optimization, equipment qualification, and regulatory oversight.
    • Completed controlled temperature unit qualification activities; Installation and Operation qualification protocol development, execution, and report development.
    • 100% metrics accomplished; i.e. on time, within budget, and 0 deviations (RFT metrics).
    • Provided technical support for the manufacture of live virus vaccine: H1N1, amounting to approx. 42 million doses.
    • Participated in the design, coordination, and timely execution of multiple simultaneous validation studies for new and existing equipment for the manufacture and release of the H1N1 vaccine.
    • Prepared SOPs to govern operation and use of equipment to be qualified, protocols, and final reports for validation activities.
    • Provided technical support for the manufacture of live based virus vaccines. This cell-culture project included equipment optimization, equipment qualification, and regulatory oversight.
    • Revised manufacturing SOPs, batch records and related forms for content, accuracy and clarity. Reviewed SOPs, batch reports, Validation Master Plans, Final report packages and investigations for GXPs and content.
    • Performed activities related to PAI (Prior to Approval Inspection). This included assistance with FDA inspections.
    • Re-Qualification of -80°C freezer farm and -25°C warehouses and packaging line.
    • Qualification of new fill/finish suite.
    • Qualification of new QA lab, including lab instruments and equipment, i.e. Vitek, HPLC’s, benchtop autoclaves, dissolution systems, incubators and stability chambers.
  • Senior Validation responsibility efforts for a high-profile pharmaceutical, manufacturer of API products, including:
    • Led equipment qualification activities; Installation, Operation, and Performance qualification execution, deviation assessments and report development.
    • Prepared equipment Validation Master Plans.
    • Completed controlled temperature unit qualification activities; Installation, Operation, and Performance qualification protocol development, execution, and report development.
    • Qualification of new RO/DI water system.
    • Performed Steam Quality Testing.
    • Completed controlled temperature unit qualification activities; i.e. Installation, Operation, and Performance qualification protocol development, execution, and report development.
    • Autoclave qualification and validation
    • Validated new distribution system for fluid transfer of API Bulk product.
    • 100% metrics accomplished; i.e. on time and within budget.
  • Senior Validation responsibility effort for a high-profile packaging and distributor of food, beverages and OTC medications, including:
    • Designed, installed and trained staff on a new wireless temperature and humidly monitoring system for the distribution and packaging warehouses.
    • This wireless monitoring system was the first of its kind and implemented without interfering with the normal operation of the facility.
    • Authored SOPs detailing validation methods and procedures; created new SOPs and revised existing SOPs for purposes of clarity, content and necessary updates.
    • Led investigational efforts in determining root causes for atypical (temperature excursion) events and established corrective and preventative actions.

PROFESSIONAL EXPERIENCE

  • Reale Resources, LLC, President (Exton, PA) – 12/13 to Present
  • ECSquared, Inc., Owner/Director of Strategic Alliances (Wilmington, DE) – 10/07 to Present
  • Adcor Industries, Engineering Sales Manager (Baltimore, MD) – 10/06 to 10/07
  • Precision AirConvey, Regional Technical Sales Manager (Newark, DE) – 01/03 to 10/06
  • Peleg Diamond Company, Regional Sales Manager (Cleveland, OH/Tel Aviv, Israel) – 1/98 to 01/03

EDUCATION

  • Master of Science in Human Resource Management, Wilmington University, Wilmington, DE – 2005
  • Bachelor of Science in Marketing and Management, Davis and Elkins College, Elkins, WV – 1988

CERTIFICATION

  • Senior Professional in Human Resources (SPHR), HR Certification Institute, 2006
  • Graduate Gemologist (GG), Gemological Institute of America – 98 to Present

TRAINING

  • cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices, CfPIE
  • Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products, CfPIE
  • Process Validation for Drugs and Biologics, CfPIE
  • APOGEE Information Suite, Siemens
  • APOGEE with BACnet for Experienced Insight Users, Siemens
  • APOGEE Advanced Operations, Siemens

Wei Cai


Consultant


Professional engineering executive with solid technical and compliance knowledge, experienced in FDA, TUV, and UL requirements, skilled in medical device design and development, manufacturing process and equipment design and development, product and process verification and validation, new product introduction, technology transfer of product and assembly lines, manufacturing automation, product and process continuous improvement, lean manufacturing, and project management. Highly credentialed with years of experience in global medical device manufacturers. Background in surgical and medical instruments, medical diagnostic apparatus, hospital diagnostic equipment, whole blood oximeters, data connectivity, microcoagulation systems, incision devices, platelet reactivity systems, electrical packaging for tunable lasers, electromechanical sensors, and automated surgical stapling devices.

CORE COMPETENCIES

  • Project Management
  • Product Development
  • Design Controls / Change Controls
  • Design History Files
  • Design Inputs / Design Outputs
  • Design Verification / Validation
  • Package Design and Validation
  • Design Changes and Design Transfers
  • Risk Management / FMEA / Hazard Analysis
  • Design Reviews
  • Process and Equipment Development
  • Equipment and Process Validation (IQ/OQ/PQ)
  • Test Method Validation
  • Production and Process Control
  • Change Management
  • Product / Process Improvements
  • Product / Process Transfers
  • Lean Manufacturing/Continuous Improvement
  • Identification and Traceability
  • Labeling and Packaging Control
  • Preventative Maintenance
  • Nonconforming Handling
  • Corrective and Preventative Action
  • Complaint Investigations
  • Statistical Analysis and Process Control
  • Supplier Qualifications
  • FDA Inspections/Remediation
  • ISO Audits/Gap Analysis/Internal Audits

SELECTED ACCOMPLISHMENTS

  • Developed two generations of the microprocessor-controlled, handheld, powered medical stapling devices and consumables, including 6 product families, 25 product extensions and accessories to reduce surgical time and improve patient safety:
    • Created and executed design and development plan, managed the projects from concept to commercialization; improved and streamlined product development process, drove projects to completion on time, within budget and in compliance with FDA regulation.
    • Led and managed design activities, including design input, risk assessment, product design, product verification / validation, manufacturing process and equipment development and qualification (IQ/OQ/PQ) and product launch; managed design history files (DHF) and organized cross-functional design reviews.
    • Provided product post commercialization supports, utilized the Voice of the Customer process to capture the requirements / feedback from customers to improve existing product quality and create new product concepts.
    • Participated in creating regulatory strategy and assisted in device 510K submissions (Class 1, Class 2 and Class 3).
  • Process developed and implemented manufacturing launch strategy for new product introduction and technology transfer:
    • Established manufacturing capability in a startup company; consolidated critical OEM supplier operations to in-house manufacturing.
    • Developed quality plans in the early product development stage to assure congruence with manufacturing strategy and quality and regulatory requirements.
    • Initiated and implemented automation strategy in early design stage, defined URSs (User Requirement Specifications) and led design and qualification of automated assembly machines.
    • Created and implemented manufacturing strategy for new product introduction and production scale-up; led new process and equipment development, created SOPs, Process Maps, Device History Records (DHR) and other production document, developed and executed process and equipment validation Plans (IQ/OQ/PQ) to ensure manufacturing readiness.
    • Established and managed pilot manufacturing operations to ensure smooth product and technology transfer from R&D to manufacturing operation.
  • Initiated and implemented key elements of manufacturing operations and strategy:
    • Drove continuous improvement by utilizing Lean, Six Sigma and Kaizen principles; Created and monitored manufacturing operation metrics to continuously identify, improve and track results of opportunities to eliminate waste of all kinds.
    • Created and implemented multi-year manufacturing automation strategy to improve safety, product quality and reduce labor costs; managed $3MM annual capital budget for manufacturing operations, improved in-process yield by 7% in a year and saved $500K annually in direct labor.
    • Created and executed strategy to manage electrical part obsolescence in instrument manufacturing and instrument service operations to sustain legacy instrument product lines.
  • Developed quality management system, highly experienced with FDA regulations, ISO, UL requirements; assisted materially in raising compliance and clearing FDA Warning Letter; participated in FDA inspection and facilitated TUV and UL audits:
    • Established and co-chaired Validation Review Board (VRB) at multiple companies to provide verification / validation strategy for product, process and equipment qualifications; Reviewed and approved verification / validation protocols and reports to ensure compliance.
    • Co-chaired Change Review Board (CRB) to control design, process and quality policy changes; reviewed and approved all change initiations, change justifications (verifications / validations) and risk assessments according to company procedures and in align with regulations.
    • A member of quality steering committees to review and approve CAPA initiations, CAPA investigations and mitigations and effectiveness verifications to ensure the effectiveness of company’s quality management system.

PROFESSIONAL EXPERIENCE

  • International Technidyne Corporation, Director, Manufacturing Engineering (Edison, NJ) – 7/09 to Present
  • Power Medical Interventions, Inc., Sr. Director, Product Development (Langhorne, PA) – 12/04 to 4/09
  • Princeton Optronics Inc., Staff Engineer (Princeton, NJ) – 11/01 to 12/04
  • JDS Uniphase Corp., Manufacturing Engineer (Princeton, NJ) – 12/99 to 11/01
  • Tyco International Ltd., Mechanical Engineer (Norristown, PA) – 10/92 to 12/99

EDUCATION

  • Master of Science, Electrical Engineering, Penn State University, Great Valley, PA – 08/04
  • Master of Science, Mechanical Engineering, University of Oklahoma, Norman, OK – 05/92
  • Bachelor of Science, Aerospace Manufacturing Engineering, Nanjing University of Aeronautics and Astronautics, Nanjing, China – 05/86

TRAINING

  • Quality Management System, ITC,
  • Quality Policy, ITC
  • ISO 13485, ITC
  • Good Manufacturing Practices, ITC
  • Good Documentation Practices, ITC
  • Nonconformance Procedure, ITC
  • Corrective and Preventive Action (CAPA) Process, ITC
  • Preparation, Control and Distribution of Controlled Documents, ITC
  • Permanent & Temporary Engineering Change, ITC
  • Process Validation
  • Supplier Quality System Assessment
  • Failure Modes, Effects & Critically Analysis (FMECA) Procedure, ITC
  • Risk Management Procedure, ITC
  • Internal Quality Audit Process, ITC
  • Complaint Handling Procedure, ITC
  • Investigation and Root Cause Analysis Process, ITC
  • Software Validation, ITC
  • Test Method Validation, ITC
  • Production and Process Control, ITC
  • Statistical Techniques, ITC
  • Product Recalls, Corrections or Removals, ITC
  • Design Controls, ITC
  • Preventive Maintenance, ITC
  • Training Process, ITC
  • Medical Device Design, FOI, 04/13
  • Lean Six Sigma Green belt, ASQ, 12/13
  • Document and Data Control, PMI
  • Design Control, PMI
  • Management Review, PMI
  • Internal Audit, PMI
  • Process Validation, PMI
  • Management of Customer Complaints, PMI
  • Biohazard Control Plan, PMI
  • Monitoring and Trending, PMI
  • Statistical Control, PMI
  • Identification Traceability, PMI
  • Medical Device Reporting, PMI
  • Technical Files, PMI
  • Software Development Standards, PMI
  • Post Market Surveillance, PMI
  • Product Recall, PMI
  • Quality System, PMI
  • Incoming Inspection, PMI
  • Strategic & Disruptive Innovation, HSM, 06/08

AWARDS:

  • THORATEC Pinnacle Award for excellence in customer and quality focus and leadership in 2010

Joseph C. Crea


Consultant


Professional with pre-clinical/concept through product launch experience in quality systems, quality management, quality assurance and engineering, contract manufacturing, and operations. Over 39 years working with drug, medical device, combination, and consumer products manufacturers. Background in transdermals, metered dose inhalers, implantables, electronics, solid dosage forms, lyophilized products, semi-solid products.

CORE COMPETENCIES

  • Quality Management/Quality Assurance
  • Quality Engineering/Quality Control
  • Design Controls/Design Reviews/DHFs/DMRs
  • Risk Management/Analysis
  • Project Management/Scheduling
  • Supplier/Contractor Management
  • Corrective and Preventative Action
  • Document Controls/Change Controls
  • Complaint Handling/Investigations
  • Technology Transfers/Product Integration
  • Product/Process Validation
  • Gas/Radiation/Steam Sterilization
  • Polymer Manufacturing
  • Critical-To-Quality (CTQ) Design
  • Product Regulatory and Launch Strategies
  • NDA CM&C Support
  • PMA/NDA Pre-Approval Inspection
  • QSR/GMP/ISO Compliance Auditing
  • 21 CFR Parts 820/210/211
  • ISO 9000/ISO 13485/ISO 14971

SELECTED ACCOMPLISHMENTS

  • Worked with a major dermatology manufacturing company, including:
    • Provided pharmaceutical quality system support.
    • Defined quality system requirements to function as virtual company in compliance with FDA 21 CFR Parts 210/211.
  • Partnered with pharmaceutical manufacturer, ranked among the top ten pharmaceutical companies in the world, including:
    • Focused on providing QSR compliance and technical support for an iontophoretic drug – device combination product.
    • Evaluated companies against FDA 21 CFR Part 820 QSR and FDA 21 CFR Part 4 Combination Product Systems/Procedures.
    • Reviewed/revised NCR, CAPA, and technical development reports.
    • Mentored QA and Project Team staff on Design Control requirements.
    • Reviewed all device history file documents and recommended/implemented corrective actions and supporting follow-up studies.
    • Acted as technical consultant.
    • Completed product safety and functionality project for company’s woman’s health division, regrading contraceptive product.
  • Supported international specialty pharmaceutical manufacturer, focusing in specialty products, OTC/nonprescription products, and branded generics, including:
    • Conducted assessment of current FDA 21 Parts CFR 210/211 Quality System pertaining to FDA 21 CFR Part 4 Combination Product requirements.
    • Developed quality system SOP’s for combination products.
    • Completed retrospective Design History File for combination products.
    • Directed combination product manufacturer, including:
    • Reviewed FDA 21 CFR Part 820 Quality systems at two manufacturing sites.
    • Performed a gap assessment at both locations against
  • FDA 21 CFR Parts 210/211, 21 CFR Part 820 and 21 CFR Part 4 Drug – Device Combination product system requirement.
    • Provided CAPA recommendations.
    • Completed FDA 21 CFR Part 820 QSR audit for one of the sites regarding a drug – device combination product.
    • Reviewed historical manufacturing NCR’s, CAPA’s and product complaints for combination product.
    • Recommended system CAPA’s and revisions to bring QSR into compliance with FDA 21 CFR Part 4 requirements.
  • Worked to support pharmaceutical manufacturing company offering branded prescription products, including:
    • Supported design and implementation of quality systems and procedures for drug-device combination product.
    • Reviewed manufacturing NCR’s, CAPA’s and product complaints for drug and device products.
  • Supported consent decree remediation activities at laboratory, including:
    • Reviewed and provided comments and corrections for manufacturing NCR’s, CAPA’s, product complaints, investigation reports and quality system audits.
    • Evaluated, designed and implemented system operating procedures as requested.
    • Reviewed and commented on system and process validations.
    • Assigned to several strategic action teams regarding customer product support.
  • Supported consent decree remediation activities at pharmaceutical manufacturer of generic prescription pharmaceuticals, including:
    • Reviewed historical manufacturing NCR, CAPA and product complaints.
    • Performed investigations on delinquent NCR, CAPA and product complaints and competed documentation as required.
    • Wrote investigation reports for missing CAPA, product complaints and quality system deviations as required.
  • Consulted with various pharmaceutical, medical device, and biologics providing quality, operations, and technical support:
    • Actively managed at least 6 international and domestic drug product tech transfer projects all FDA approved.
    • Developed scale up activities for several drug – device products and designed two corporate level technical transfer policies.
    • Developed DHF and DMRs for combination products for pharma/device manufacturers.
  • Supported various quality engineering activities for pharmaceutical, medical device, biologics and new technology product development teams, including:
    • Performed internal and external GMP/ISO audits.
    • Design company wide QA/QE systems.
    • Designed and implemented company-wide design control system.
  • Directed tasks as part of quality strategic plan for global external manufacturing operation for 4 billion dollar CMO portfolio, including:
    • Developed innovative quality systems to support global external manufactured products.
    • Directed team of 8 QA Managers working in “virtual plant” environment.
    • Supported and developed global due diligence activities.
    • Partnered with internal Operations, RA, R&D, Technical Service, and Franchise Management organizations supporting base business and new product teams.
  • Managed both strategically and hands-on for several supply chain, technical operations, new products, planning, and organization design activities for global virtual start-up company, including:
    • Staffed Operations, Logistics, Quality, and Technical Operations functions.
    • Directed integration/tech transfer strategies for 6 acquired products.
    • Identified and qualified global partners including CMO’s, Packaging, API suppliers, and 3PL’s.
    • Provided technical (IP review) and commercialization support for new business opportunities.
    • Resolved alliance management supply chain/quality risks with new business partners.
  • Managed contract manufacturing operations for major pharmaceutical manufacturer, including:
    • Directed team responsible for quality/compliance of contract manufactured products.
    • Directed supplier quality and product complaint system.
    • Developed strategies with Operations/R&D to support new products launch at CMOs.
    • Performed due diligence assessments of potential sites and IP.
  • Facilitated quality system efforts for manufacturer of pharmaceutical, biologics, and medical device products, including all aspects of GMP compliance and product quality at CMO’s (base business and new products).

PROFESSIONAL EXPERIENCE

  • JCrea Consulting Inc., President (Hamilton Square, NJ) – 2009 to Present
  • ECG BioPartners, LLC, Managing Consultant (Hamilton Square, NJ) – 2009 to 2011
  • Iroko Pharmaceutical, LLC, Sr. Vice President Operations & Quality (Philadelphia, PA) – 2007 to 2008
  • J&J, Global Pharmaceutical Supply Group, Dir., QA, Global Ext. Mfg. (Titusville, NJ) – 2001 to 2007
  • Janssen Pharmaceutica, LLC, Director Contract Manufacturing (Titusville, NJ) – 1999 to 2001
  • Janssen Pharmaceutica, LLC, Manager Contract Manufacturing (Titusville, NJ) – 1995 to 1999
  • Ethicon (J&J), Sr. Quality Assurance Engineer (Somerville, NJ) – 1991 to 1995
  • J&J Medical, Inc., Quality Systems Specialist (New Brunswick, NJ) – 1988 to 1991
  • Packaging Corp. of America, Dir. Quality Assurance (Piscataway, NJ) – 1986 to 1988
  • Bristol Myers Squib-Chas. Of Ritz, LTD, Mgr. Corp. Quality Systems (Middleton, NJ) – 1982 to 1986
  • C.R. Bard, Inc., Urological Div., Division QA Mgr. Med Devices (Murray Hill, NJ) – 1977 to 1982
  • American Can, Consumer Products Div., Product Development Tech. (Princeton, NJ) – 1976 to 1977

EDUCATION

  • B.S. Biology, Montclair State University – 1975

CERTIFICATION

  • Certified Quality Engineer (ASQC) – 1991
  • Certified Quality Auditor (ASQC) – 1992
  • ISO Certified Assessor – 1992
  • Certified Pharmacy Technician – 2010

Carolyn de Jonge


Consultant


Professional with solid compliance knowledge, skilled in quality management systems. Highly credentialed with years of experience with medical device and drug manufacturers. Background concentrated in in vitro diagnostics and sterile/reusable surgical medical device products.

 

CORE COMPETENCIES

  • FDA Inspections/Remediation
  • Precertification Audits/ISO Audits
  • Gap Analyses/ Internal Audits
  • External Audits/Supplier Audits
  • Product Audits/Process Audits
  • Design History File Audits
  • Batch History Reviews
  • Quality System Development
  • Corrective and Preventative Action
  • Complaint Investigations/Product Recalls
  • Adverse Event/Medical Device Reporting
  • Label Review/Approval
  • FDA 21 CFR Parts 820/210/ 211
  • ISO 9001/ISO 13485
  • SOR/98-282
  • Auditor Training/Procedural Training

SELECTED ACCOMPLISHMENTS

  • Conducted audits of medical device manufacturers for major international accredited third party management system certification registrars for assessment and registration to the criteria set forth in ISO 9001 Standard Series and applicable related sector standards, including ISO 13485
  • Completed audits for compliance with 21 CFR Part 820 for medical device manufacturers of reusable and sterile disposable products
  • Performed audits for compliance with 21 CFR Parts 210/211 for drug manufacturers
  • Managed various project activities for largest medical device manufacturer of minimally invasive surgery products, specializing in urology and gynecology, including:
    • Administered, monitored, and audited quality system, reporting status of system and its effectiveness to upper management as related to ISO 9001, ISO 13485, and 21 CFR Part 820
    • Upgraded quality manuals to ISO 9001 requirements
    • Developed process validation procedures for product sterilization, utilizing gamma, ethylene oxide, and electron beam sterilization
    • Coordinated complaint program, specifically activities related to investigations, ensuring that incidents reported accurately, Medical Device Reports (MDR’s) submitted in accordance with 21 CFR Part 803, and complaints closed out in timely manner
    • Submitted appropriate technical information for international device registrations
    • Participated in Material Review Board (MRB) meetings to determine disposition of nonconforming material based upon investigations to identify root cause and appropriate corrective and preventative actions
    • Participated in Engineering Change meetings to assess need for revalidations
    • Developed and implemented procedures for improved operations and enhanced compliance
    • Conducted training on Quality System Regulation (QSR)
  • Facilitated numerous compliance activities for medical device manufacturers of coagulation testing and therapeutic devices, including:
    • Conducted reviews of Device History Records (DHR’s) to ensure lots manufactured in accordance with Device Master Records (DMR)
    • Developed and implemented documentation, including Standard Operating Procedures (SOP’s) and work instructions, required for addressing gaps in quality systems
  • Managed several clinical qualification and regulatory affairs undertakings for medical device manufacturer of in vitro diagnostics used in hematology laboratories, including:
    • Organized and led internal audits as required by internal audit program
    • Conducted compliance audits of manufacturing areas for various operations
    • Coordinated recalls, specifically development of recall strategies, identification of impacted product, and removal and/or correction of product
    • Processed customer complaints, handling investigations, identification of root cause, and documentation of records

PROFESSIONAL EXPERIENCE

  • Independent Consultant/Auditor for DEKRA Certification, Inc. (Willow Grove, PA) – 1999 to Present
  • Independent Consultant/Auditor for Keystone Technical Associates (Willow Grove, PA) – 1999 to 1999
  • Circon Cabot, Complaint Coordinator (Langhorne, PA) – 1996 to 1999
  • Circon Cabot, GMP Compliance Coordinator (Langhorne, PA) – 1994 to 1996
  • Circon Cabot, Quality Assurance Engineer (Langhorne, PA) – 1988 to 1994
  • Independent Consultant, Principal Consultant/Contract Auditor (Willow Grove, PA) – 1987 to 1988
  • Geometric Data Corporation, Manager, Clinical Qualification/RA (Wayne, PA) – 1981 to 1987
  • Geometric Data Corporation, Manager, Clinical Qualification (Wayne, PA) – 1979 to 1981
  • Geometric Data Corporation, Chief Technologist (Wayne, PA) – 1978 to 1979
  • Geometric Data Corporation, Senior Technologist (Wayne, PA) – 1975 to 1978
  • Abington Memorial Hospital, Hematology Technologist (Abington, PA) – 1971 to 1975
  • Royal Perth Hospital, Cytogenetics Technologist (Perth, Australia) – 1969 to 1971
  • Temple University, Research Technologist (Philadelphia, PA) – 1968 to 1969
  • Abington Memorial Hospital, Hematology Technologist (Abington, PA) – 1964 to 1968

EDUCATION

  • Bachelor of Science in Medical Technology, Temple University, Philadelphia, PA – 1961 to 1964

CERTIFICATION

  • Certified Quality Auditor (CQA), American Society for Quality – 1992 to Present
  • Certified Lead Auditor for ISO 13485/ISO 9001 (Certificate #6876), RABQSA – 1998 to Present
  • Lead Auditor for Medical Devices Quality Systems for ISO 13485, ISO 9001, and EAC/IEF codes: 12, 14, 19, DEKRA Certification Inc. (formerly KEMA Registered Quality Inc.) – 7/09 to Present

TRAINING

  • Auditor Training, KEMA Registered Quality Inc. – Annual training 2001 to 2012
  • Canadian Medical Devices Conformity Assessment System, Health Canada – 2001
  • ISO/DIS 9000:2000 Overview, American Society of Quality – 2004
  • Advanced Auditing of Management Systems, Quality Management International, Inc. – 2008
  • Survey of Basic Statistical Methods Useful to MDD & ISO Auditors, KEMA – 2010
  • Elementary Statistics (Statistics 101), Penn State – 1985

AFFILIATIONS

  • American Society for Quality (ASQ) – 1989 to Present
  • American Society of Clinical Pathology (ASCP) – 6/64 to Present

Monica Ferrante


Consultant


Professional medical device consultant with solid technical and compliance knowledge, skilled in quality systems, process validation, product development and improvement, and regulatory approvals and submissions. Highly credentialed with years of experience in top global U.S., European, and Canadian, medical device manufacturers. Background in capital electro-medical equipment, disposable devices, implants, sterile devices, combination products (drug/device), IVDs and surgical instruments.

CORE COMPETENCIES

  • World Wide Regulatory Approvals
  • Project Management
  • Product Development
  • QSR
  • Annex II MDD Quality System Certification
  • ISO 13485
  • CDMR Certification
  • FDA and CE Mark
  • Procedure Systems/Design History
  • Infant Resuscitation
  • Process Improvement
  • Software Quality Validation
  • Risk Management
  • JCAHO Certification
  • ISO 9001
  • EN 46001
  • 510 (k) s
  • International Standards Development
  • cGMP
  • TQM

SELECTED ACCOMPLISHMENTS

  • Developed product V&V and design history, vender selection and management for worldwide regulatory approval including distribution of Atom Medical Incubators, Warmers and Transports, Infant Resuscitation, Pediatric/Adult Resuscitation systems and accessories
  • Participated as key person in divestiture of Air Shields and integration of two organizations and quality systems
  • Directed regulatory affairs and quality for North American Ventilator and Anesthesia division, Perinatal Care division, and Monitoring division
  • Established all human resource requirements for start up company
  • Obtained FDA, CE, and Canadian regulatory approvals for insulin pump, quality system certification and JCAHO accreditation for home use products
  • Supported product development of external infusion pump and pre-clinical work on implantable glucose measurement device
  • Managed quality department of 5 technicians responsible for all quality assurance and software validation functions
  • Supported new product development, validation, verification and documentation of design control processes
  • Supported all manufacturing process control and clean room compliance for surgical laser systems, surgical hand instruments and OEM products
  • Managed team of 13 engineers and technicians responsible for strategic work for arrhythmia reclassification and international standards development
  • Managed team of 7 engineers and technicians in software validation processes for patient monitoring portfolio, GMP compliance, quality system certification to EN46001, and implemented TQM and process improvement
  • Managed worldwide regulatory approvals for defibrillators, electrocardiographs, Holter monitoring, and ECG management systems
  • Edited diagnostic and Fetal Doppler Ultrasound Guidance for FDA, and was responsible for engineering review of premarket approval applications

PROFESSIONAL EXPERIENCE

  • Independent Consultant, (Conshohocken, PA – 1994 to Present
  • NeoForce Group, Inc., VP Regulatory, (Warminster, PA) – 2006 to Present
  • Hill-Rom Air Shields, Director Regulatory and Quality, (Lancaster, PA) – 2000 to 2006
  • Animas Corporation, Director Regulatory and Human Resources, (West Chester, PA) – 1999 to 2000
  • Surgical Laser Tech, Director RA/QA, (Montgomeryville, PA) – 1996 to 1999
  • Hewlett Packard, Medical Products, Manager, Regulatory Approvals, (Andover, MA) – 1989 to 1996
  • Food &Drug Admin., Reviewer, OB/GYN, ENT and Dental Devices, 1987 to 1989
  • Bendix Field Engineering, Systems Analyst, (NASA Goddard) – 1985 to 1987
  • Capital College, Adjunct Professor, (Laurel, MD) – 1982 to 1985
  • Singer Company, Link Div., Lead Engineer, (Silver Spring, MD) – 1980 to 1985
  • Modification Systems, Inc., Programmer. (Santa Fe Springs, CA) – 1979 to 1980

EDUCATION

  • Doctorate Public Administration, University of Southern California – 8/04
  • Masters Public Administration, University of Southern California – 8/03
  • M.S. Physiology, Georgetown University, 5/88
  • B.S. Biomedical Engineering, Catholic University, 5/79

PUBLICATIONS AND PRESENTATIONS

  • 1 Patent Issued, 1 Patent Pending for pediatric/adult resuscitation device
  • Guest Lecturer, University of Pennsylvania Center for Technology Transfer, Masters in Translational Research
  • Guest Speaker, Small Business, New Technology, and Regulatory Affairs seminars

David V. Gorky


Consultant


Professional with solid technical background, skilled in product development, project management, and manufacturing engineering. Highly credentialed engineer with years of experience with top global medical device and drug manufacturers. Background in diagnostics, venous access safety related kits, anesthesia, dialysis access, catheter-based and antimicrobial technologies, pressure rated PICC devices, drug coated and uncoated peripheral stents, interventional radiology and cardiology products, stentgrafts, delivery systems, stage-gate process, sirolomus coated stents, bioabsorbable orthopedic and urologic implantable devices, implantable drug delivery systems, and ligament repair systems.

CORE COMPETENCIES

  • Product Development
  • Design Control/ Stage-Gate Processes
  • Design History Files (DHFs)
  • Device Master Records (DMRs)
  • Design Verification/Design Validation
  • In Vivo/In Vitro Test Methods
  • Hands-On Surgical Testing
  • Clinical Trials/Testing
  • Equipment Installations
  • Process Validations/Test Method Validations
  • Risk Analysis/FMEA/FMECA
  • Technical Files/IDEs/510Ks/PMAs
  • Project Management/Project Plans
  • Forecasts/Budgets
  • FDA 21 CFR Part 820
  • FDA 21 CFR Parts 210/211
  • ISO 13485/ISO 14971/ISO 11607
  • Procedural Development/Work Instructions
  • Change Management/Change Controls
  • Process Excellence/Cost Savings Initiatives

SELECTED ACCOMPLISHMENTS

  • Led technical activities for diagnostics manufacturer of reagents and other products, including:
    • Designed and developed diagnostic reagents in compliance with regulations
    • Supported development of dossiers, PMAs, Design History Files, etc.
  • Served as advisor to medical device and pharmaceutical companies providing project management, product development, quality system, and strategic planning, including:
    • Designed and developed medical devices in compliance with regulations
    • Supported development of combination drug device products
    • Provided strategic and tactical support during several class II recalls
    • Provided regulatory support for Technical Files, IDEs, 510K, and PMA submissions
    • Provided essential review and remediation to support transfer of medical device company into pharmaceutical company
    • Developed and implemented quality systems to meet the Quality System Regulations and European standards, such as ISO 11607, ISO 13485, and ISO 14971
    • Developed SOPs and specifications to complete Design History Files and Device Master Records
    • Audited quality systems and associated records for compliance identifying opportunities to strengthen and secure stability of quality systems platform
    • Developed remediation project plans, risk assessments, FMECA, forecasts, and budgets
    • Developed dashboards, reports, and presentations to keep management abreast of progress
  • Led product development activities for medical device manufacturer of balloons, catheters, and other custom extrusion products, including:
    • Facilitated all medical device design, development, and manufacturing with 100 associates and three U.S. locations
    • Supported start-ups and multi-national organizations with standalone and supplemental services, such as engineering, testing, project management, clinical supplies, clean room commercial manufacturing, and quality system development, execution, and remediation
    • Maintained over 50 active device projects which grew sales by over 20% and profitability by 125%
    • Supported systems to maintain compliance with ISO 13485 and ISO 14971
  • Coordinated product development activities for medical device manufacturer of broad range of venous access, regional anesthesia, and dialysis access catheter-based therapeutic products and antimicrobial technologies, including:
    • Managed budget of over $8 million, staff of six direct reports, and 30 indirect reports
    • Served as member of executive team responsible for portfolio and project management
    • Launched six pressure rated PICC devices and 24 venous access safety related kits, generating first year sales of over $25 million
    • Launched first pressure rated CVC catheter and Step Tip hemodialysis catheter which generated an additional $25 million in first year revenue
    • Implemented new quality system, associated SOP’s, documentation, and validations in response to FDA warning letter received prior to tenure
    • Identified and negotiated strategic partnerships and licensing arrangements
  • Directed engineering activities for medical device manufacturer of peripheral vascular and endovascular products, including:
    • Managed 50 % increase in staff during period of double-digit growth to introduce 40 new products, leading staff of six managers and 80 associates to coordinate product development across eleven companies in four countries
    • Served as member of executive committee responsible for guiding merger and acquisition activities while managing company’s launch of TaxolTM drug coated and uncoated peripheral stents, interventional radiology and cardiology products, Zenith TM  AAA stentgrafts, and delivery systems
    • Implemented stage-gate process with marketing to ensure balanced project portfolio
    • Modified design control procedures to incorporate ISO 13485 and ISO 14971
    • Worked in partnership with business development to perform due diligence on licensing and acquisition opportunities
    • Assessed procedures and processes to evaluate change and cost reduction measures with first year reductions exceeding $2 million
  • Managed product launch activities for biomaterials manufacturer of Sirolomus coated stents, bioabsorbable orthopedic and urologic implantable devices, and other implantable drug delivery systems, including:
    • Identified new business opportunities, licensing, and acquisition candidates
    • Managed project portfolio and maintained steady flow of products to market
    • Partnered with operating companies to develop strategic plans and assess market potential for collaborative projects
    • Formed new company with development corporation and outside venture company based on underutilized technology
    • Completed pilot clinical trials and attracted second round funding partners
    • Implemented process excellence program for overall improvement
    • Developed and negotiated variety of legal agreements
    • Instituted healthcare compliance based on HIPPA and AMA guidelines and administered $2MM government matching fund grant
  • Led strategic planning and management group for biomaterials manufacturer of orthopedic products, including:
    • Managed project leaders in developing new materials and products that supported  medical device and diagnostics sector operating companies
    • Developed project plans, assigned and managed resources, and presented recommendations to senior management
    • Designed and implemented project selection and management process and implemented project planning and database software to enhance efficiency
    • Led development and launch of Rigid-fixTM anterior cruciate ligament repair system which exceed sales expectations in years two and three by 100%
  • Directed team focused on research and analysis of medical industry markets, competitors, and products for medical device manufacturer of access, biosurgery, endo, energy, gastric banding, gynecology, hernia, ligation, stapling, and wound closure products, including:
    • Managed one-on-one interviews with leading surgeons and medical personnel
    • Identified licensing and acquisition targets
    • Developed specific business plans/proposals
    • Summarized and presented findings to senior corporate management leading to efforts that resulted in three acquisitions and closing of numerous licensing deals
    • Managed new product implementation group for medical device manufacturer with responsibility for administration, planning, budget, and development of new medical devices and processes
    • Coordinated equipment procurement and installation, validation of processes and test methods, and transfers to manufacturing
    • Led three device development and product launch teams, including Lapra-TyTM suture clip
    • Served as member of corporate ISO and FDA Quality Systems steering committees
    • Coordinated in vivo and in vitro test methods and “hands-on” surgical testing
  • Facilitated engineering activities for custom molder and assembler of precision components, including:
    • Drove “turn-around” from six years of consecutive losses to profitability, thereby increasing value and marketability and attracting several potential buyers
    • Reorganized sales and marketing, engineering and quality assurance departments
    • Increased group dynamics and decreased response time to customers
    • Served as member of board of directors which negotiated new union contract
    • Identified and negotiated acquisition of tool and die company
    • Founded FDA registered medical manufacturing company

PROFESSIONAL EXPERIENCE

  • Independent Consultant (Flemington, NJ) – 2007 to Present
  • Vention Medical, Inc., Vice President Product Development (Marlborough, MA) – 2011 to 2012
  • Arrow International Inc., Sr. Dir. Global Critical Care Product Dev. (Reading, PA) – 2005 to 2007
  • Cook Incorporated, Director of Engineering (Bloomington, IN) – 2003 to 2005
  • J&J Ctr. for Biomaterials/Advanced Tech., Mgr., New Program Dev. (Somerville, NJ) – 2000 to 2003
  • J&J Corporate Biomaterials Center, Manager, Project Management (Somerville, NJ) – 1996 to 2000
  • Ethicon, Div. of Johnson & Johnson, Mgr. Strategic Planning/Bus. Dev. (Somerville, NJ) – 1994 to 1996
  • Ethicon, Inc., Div. of Johnson & Johnson, Principle Engineer (Somerville, NJ) – 1991 to 1994
  • JDI Technologies, Principal (Putnam, CT) – 1990 to 1991
  • Moldex, Inc., Vice President of Engineering (Putnam, CT) – 1987 to 1990
  • Moldex, Inc., Director of Engineering (Putnam, CT) – 1986 to 1987
  • Celanese Specialty Operations, Applications Engineer (Summit, NJ) – 1985 to 1986
  • Johnson & Johnson Baby Products Co., Plastics Packaging Coordinator (Skillman, NJ) – 1982 to 1985
  • Stromberg Carlson Corp., Manufacturing Engineer (Charlottesville, VA) – 1980 to 1982

EDUCATION

  • Master of Science, Plastics Engineering, University of Lowell (Lowell, MA) – 1986
  • Bachelor of Science, Plastics Engineering, University of Lowell (Lowell, MA) – 1980

AFFILIATIONS

  • Society of Plastics Engineers
  • Product Development Management Association

PATENTS

  • Awarded six issued U.S. Patents

Paul V. Gorky


Consultant


Comprehensive packaging development/project engineering background with pharmaceutical companies, world’s leading direct seller of beauty products, and preeminent consumer foods. Leadership, technical, and program management expertise across OTC pharmaceutical consumer products, packaging industries, food, and beverage. Product and packaging development, including aseptic, hot-fill, and dry product applications, environmental impact issues, packaging line development, and vendor management. Demonstrated successes in marketing, coordinating, and launching a wide variety of new products and packages. Extensive knowledge of multi-layer and mono-layer plastic containers, glass containers, multi-layer pouches, corrugated cartons/cartoning, labeling, metal/plastic closures, metal/spiral wound cans.

CORE COMPETENCIES

  • Project Management/Project Leadership
  • Project Charters/Project Planning
  • Package Engineering/Technology
  • Product Launches/ Technology Transfers
  • Product Improvement/Changes
  • Supplier Changes/Engineering Change Orders
  • Packaging Qualifications/ Packaging Validations Package Material Testing/Test Methods
  • Operating Procedures/Work Instructions
  • Drop Testing/Transportation Testing
  • Primary Packaging Designs/Specifications
  • Secondary Packaging Designs/Specifications
  • Packaging Specifications/ Specification
  • Cold Chain Parameters

SELECTED ACCOMPLISHMENTS

  • Managed packaging development for numerous new products in FDA regulated environment with primary packaging, ranging from glass, to multi-layer plastic, as well as many other packaging types.
  • Worked primarily in cross-functional teams, including Marketing, Sales, Procurement, QA/QC, Package Equipment Engineering, and Product Development, including the following:
    • Supplied all prototype packaging in support of initial shelf-life testing and focus group analysis.
    • Developed primary, secondary, and tertiary packaging, together with writing and issuance of all specifications.
    • Managed distribution testing of all new packaging in support of specification development.
    • Conducted factory acceptance testing of new equipment and validation runs prior to production start-up.
    • Managed technology transfers to other operating facilities following initial production.
  • Developed novel new shipping container for frozen Guava Concentrate (Ocean Spray Cranberries), including the following:
    • Initiated search for cost-effective alternative package in conjunction with Purchasing, Production, and QA.
    • Worked with Microbiology group to establish cold chain parameters, needed for success of new package.
    • Developed and conducted testing methodology to determine freezing rate under various warehouse conditions.
    • Conducted shipping tests plus ocean transport.
  • Prepared and issued final specifications, along with operating/set-up instructions, for new packaging, including the following:
    • Served on HACCP team consisting of QA, Product Processing, and Packaging, as well as several outside resources, formed to evaluate potential product recall following large scale spoilage of FDA regulated product.
    • Conducted analysis of current packaging/processing conditions, documenting gaps between established parameters and actual practice.
    • Determined scale of potential product spoilage and developed non-destructive test methodology to screen on-hold product, resulting in savings in excess of $500K.
    • Coauthored HACCP plan to enhance production line set-up and operation.
    • Conducted training classes, to familiarize production personnel with new procedures.
  • Developed and wrote over 100 packaging guidelines, consisting of photographic illustrations as manufacturing operational aides.
  • Conducted package distribution testing (ASTM and ISTA), along with controlled temperature storage, for wide range of commercial clients.
  • Created and implemented computer-based specification system linking corporate functional groups (Packaging, QA, and Purchasing) and all company-owned manufacturing facilities.
  • Developed and launched hundreds of new primary packages, including an Ameristar award winner (private label razors) and Clear Choice (Glass Mfg. Assoc.) award winner (hot –filled juice product).
  • Converted secondary container shipping cases for hot-filled plastic bottles, from heavy duty RSC’s with “H” dividers, to more economical Bliss style containers.
  • Conducted cost analysis of cut and stack labels compared to roll-fed wrap-around labels, leading to conversion of roll-fed labeling system, resulting in savings of $250K.
  • Managed joint venture development of aseptic dispenser for high volume commercial customers, including the following:
    • Established development parameters for packaging and dispensing, comprising deliverables and success criteria.
    • Conducted pilot plant testing to determine product shelf-life, on and off dispenser, as well as procedures and validation testing.
    • Managed field testing of dispenser and generated final report to management.

PROFESSIONAL EXPERIENCE

  • Energizer Personal Care, Sr. Packaging Development Engineer – 2008 to 2013
  • The Schwan Food Co., Sr. Engineer – Packaging Innovation – 2008 to 2008
  • H.P.Hood LLC., Packaging Development Manager – 2007 to 2008
  • Pfizer Inc., Consultant – Package Engineering – 2006 to 2007
  • Avon Products Inc., Sr. Packaging Engineer – 2004 to 2006
  • Unilever-Bestfoods, Sr. Group Manager-Packaging Technology – 1999 to 2003
  • Ocean Spray Cranberries, Inc., Manager of Established Packaging – 1987 to 1999
  • Thomas J. Lipton, Packaging Development Engineer – 1980 to 1987
  • CPC Best Foods, Packaging Technologist – 1978 to 1980
  • Package Research Laboratory, Assoc. Packaging Technologist – 1976 to 1978

EDUCATION

  • Master of Business Administration, Industrial Management, Fairleigh Dickinson University – 1977 to 1981
  • Bachelor of Science, Forestry, Forestry-Wood Technology, University of Maine – 1971 to 1976

TRAINING

  • Leadership Development Program, Center for Creative Leadership
  • SPC and Experimental Design, University of Tennessee
  • Aseptic Processing Workshop, Purdue University
  • Executive Presentation Skills, Comunispond, Inc.
  • Workshop on glass packaging integrity, NFPA

AFFILIATIONS

  • Professional Member, Institute of Packaging Professionals (IOPP) – 1980 to Present