Jeffrey M. Singer, Ph.D.


Consultant


Senior professional with technical, managerial, business process, and scientific knowledge, skilled in regulatory compliance, analytical development, product development, and quality control. Ph.D in Organic Chemistry with over 25 years of experience in the drug and combination product manufacturing, food manufacturing, and environmental industries. Background in parenteral, liquid, solid, and semi-solid drug products, including small molecules (Coumadin®), an Alzheimer’s drug, generic OTC, and sterile products, pain management drugs (Percodan®, Naloxone®, Narcan®, Numorphan® and Naltrexone®), and flavorants (Vanillin).

CORE COMPETENCIES

  • Project Leadership/Project Management 21 CFR Part 210/Part 211/Part 820/Part 11
  • Quality Plans/Project Plans/Project Charters/21 CFR Part 110/Part 111
  • Quality Systems /Procedural Development/ISO 9000/ISO 13485
  • FDA Inspections/Remediation/CTD Dossier Preparation
  • Gap Analyses/Auditing/Analytical Method /Equipment Validations (IQ/OQ/PQ)
  • Change Management/Change Controls/Stability-Indicating Methods/Validations /Transfers
  • Corrective and Preventative Action (CAPA)/Validation Master Plans/Cleaning Validations
  • Risk Assessment /HACCP FMEA/ICH Q9/Process Improvements

SELECTED ACCOMPLISHMENTS

  • Served as subject matter expert and contributed to team remediation accomplishments on various projects involving recalls, warning letters, consent decrees, including:
    • Provided technical guidance on combination product design team for metered dose inhaler
    • Audited R&D product development and product history reports following warning letter for re-introduction of combination product
    • Provided technical input on failure investigation for issues regarding pre-filled syringes
    • Reviewed/approved CAPA investigations for laboratory/manufacturing operations regarding outstanding issues related to pharmaceuticals, sterile products, biologics, and combination products
    • Prepared training modules for root cause analysis for investigations and CAPAs per FDA and ICH guidelines
    • Conducted GMP audits for operational compliance and developed responses to FDA compliance problems, notices of observations, warning letters, and consent decrees
    • Audited annual stability reports, protocols, studies, and supporting documentation for data integrity, accuracy, and completeness
    • Assessed handling of out-of-specification results, deviations, and CAPAs
    • Performed regulatory compliance and risk assessments for laboratory investigation related to remediation activities for FDA warning letter
    • Provided guidance for cleaning validation and verification for sterile manufacturer
    • Audited formulation R&D documentation of generic formulations for PAIs per ICH Q8/9
    • Conducted CMC auditing, specifically assessments of 12 ANDA filings to determine whether product was manufactured and tested in conformity with CMC controls and FDA-approved applications, and whether analytical methods for in-process controls, finished product testing, and stability monitoring were reliable and accurate
    • Authored 100% effectiveness recall script for repackaging operation of firm that serves long-term care facilities, and drafted SOP for destruction of controlled substances incorporating DEA Form 41
    • Performed independent assessment of business process, roles, responsibilities, and functions of quality unit operations for product development R&D groups according to GxPs/ICH Q9
    • Audited LC/MS method validations at clinical trials CRO in support of clinical trials testing, providing GAP analyses comparing methods validation status against current ICH criteria
    • Created CTD Module 3 Dossiers and GAP analysis for registering OTC products in domestic/new overseas markets according to principles outlined in ICH Q8(R2), Q9, and Q10
    • Provided QA/QC support for clinical documentation at biopharmaceutical company for NDA registration package, revising and editing PK/PD reports, clinical study reports, and CTD Modules 2 and 5
    • Authored stability system SOPs for clinical supplies repackaging facility
    • Provided subject matter expert support for LIMS implementation per GAMP5 at biopharmaceutical development company
    • Managed LIMS stabilization/remediation project, responsible for forensic investigation of system failures, project plan, and final report, supervising 2 subject matter experts responsible for reviewing original LIMS implementation and developing actionable plans to correct on-going issues and system instability
    • Prepared, executed, and/or conducted reviews of CSV deliverables for Documentum upgrade, including, but not limited to, compliance assessments, corrective action plans, CSV/SLC documentation, validation plans, user/functional requirements, configuration specifications, protocols (IQ/OQ/PQ, UAT, traceability matrices, etc.), test scripts, test summary logs, and validation summary reports according to GAMP4
    • Reviewed and executed test scripts for commissioning of manufacturing equipment and PLC devices, including labelers
    • Developed documentation as required for assigned projects (SOPs, guidelines, summaries, training, etc.)
  • Provided compliance support for computer validations activities for manufacturer under consent decree, including:
    • Reviewed and certified computer performance qualification documents for enterprise-wide applications, spreadsheets, operating systems, user interfaces, etc., under terms specified in consent decree document and compliance with CGMP’s and 21 CFR Part 11
    • Audited unexecuted protocols and executed computer system validation studies for applications, such as, but not limited to, SAP, Documentum, TrackWise, CMMS, EDMS, WMS, ISOtrain, etc., for conformance to predetermined acceptance criteria and compliance with CGMP’s, 21 CFR Part 11, and GAMP
    • Assured documentation, such as change control, SOP’s, training records, etc., conformed with terms specified in consent decree and compliance with CGMP’s
    • Authored reports summarizing deficiencies of protocols and/or study results for subsequent FDA review
    • Issued approval certificates for subsequent protocol execution and/or study results following resolution of all issues and compliance with CGMP’s and 21 CFR Part 11
    • Trained 3 consultants to support computer validation efforts and successfully met consent decree commitment project timelines
    • Served as subject matter expert for computer system validation related to Part 11 questions, issues, and GAP analysis
    • Reviewed current SOPs and work instructions for predicate rule compliance, security requirements, disaster recovery, and data retention plans
  • Managed operations of quality control unit with supervision of technical personnel supporting new product research and development, GMP laboratory documentation control, and stability, including:
    • Prepared department budget of $3,000,000 for staffing and $500,000 for capital equipment
    • Designed new analytical testing laboratories in conjunction with facilities expansion
    • Prepared commissioning and validation documentation for major laboratory equipment (e.g., GC, HPLC)
    • Reviewed and approved IQ/OQ/PQ validation protocols and executed protocols for CGMP compliance
    • Reviewed sponsor-developed clinical trial protocols for new carrier/drug combinations
    • Authored compliance documents, stability reports for CMC sections, SOP’s, specification documents, and certificates of analysis ( COA’s ), stability portions of CMC section for NDA filings, out-of-specification (OOS) investigation reports, GLP toxicology sample analysis summary reports, and clinical pharmacokinetic data reports, and implemented change control procedures
    • Authored primary ICH harmonized stability protocols for transfer to contract research organizations and reviewed data received for product quality assurance
    • Authored change control SOP and established company change control review board
    • Successfully completed computer validation report for laboratory Turbochrom Workstation
    • Contributed to writing requirements and functional specifications documents in compliance with 21 CFR Part 11 for Turbochrom Client Server as member of corporate Turbochrom Validation Team
    • Interacted with FDA during routine inspection and eliminated potential 483 observations
    • Authored quality function SOPs and conducted training on new and revised SOPs
  • Managed operation of R&D lab with 8 technical personnel for new semi-solid generic OTC product development in support of overall business process, including:
    • Coordinated and tracked cleaning validation testing activities to ensure compliance, prepared cleaning validation master plan (Team Leader of Cleaning Validation Project)
    • Prepared 13 product cleaning validation protocols, managed successful execution, and authored reports within 6 months without any FDA 483 observations upon re-inspection
    • Reviewed incoming method validation reports from contract research organizations ( CROs ) for accuracy, completeness, and compliance with USP and FDA method validation guidelines
    • Facilitated transfer of new methods to quality control group from developing groups, and prepared technology transfer reports certifying acceptable methods transfers

PROFESSIONAL EXPERIENCE

  • PharmaBasics, Inc., Senior Consultant (Tarrytown, New York) – 2003 to Present
  • Emisphere Technologies, Associate Director, Quality Support (Tarrytown, NY) – 2000 to 2002
  • G&W Laboratories, Mgr., Analytical Research/Methods Dev. (South Plainfield, NJ) – 1997 to 2000
  • Clay-Park Labs, Inc., Mgr., Contract Product Dev., Analytical Laboratory Mgr. (Bronx, NY) – 1995 to 1997
  • DuPont Merck Pharma. Co., Mfg. Div., Principal Scientist, Analytical Tech. (Garden City, NY) – 1993 to 1994
  • DuPont Merck Pharma. Co., Mfg. Div., Mgr., Analytical Tech. Support (Garden City, NY) – 1990 to 1993
  • Pall Corporation, Laboratory Mgr. (Glen Cove, NY) – 1989 to 1990
  • Pepsico, Inc., Senior Chemist, Concentrate Operations (Valhalla, NY) – 1987 to 1989
  • Lederle Labs, (American Cyanamid), Analytical Dev. Chemist (Pearl River, NY) – 1986 to 1987
  • Revlon Health Care, Senior Chemist, Lab Supv. (Tuckahoe, NY) – 1981 to 1986
  • Chemtech Consulting Group, Inc., Group Leader (New York, NY) – 1980 to 1981
  • Equitable Environmental Health, Inc., Analytical Chemist (Woodbury, NY) – 1979 to 1980

EDUCATION

  • Ph.D. in Organic Chemistry, Polytechnic University, Brooklyn, NY
  • Master of Arts in Chemistry, Queens College, Flushing, NY
  • Bachelor of Science in Chemistry, Queens College, Flushing, NY
  • Master of Science, Geochemistry, Rensselaer Polytechnic Institute, Troy, NY

 CERTIFICATION

  • Certified API Auditor for Q7A, SGS Certification – 2010

AFFILIATIONS

  • American Association for the Advancement of Science
  • American Association of Pharmaceutical Scientists
  • American Chemical Society
  • Association of Official Analytical Chemists
  • American Society for Quality
  • International Society for Professional Engineering
  • New York Academy of Science
  • NY Hall of Science
  • New Jersey Pharmaceutical Association of Science and Technology
  • New Jersey Pharmaceutical Quality Control Association
  • Parenteral Drug Association
  • Regulatory Affairs Professional Society
  • SigmaXi

PUBLICATIONS AND PRESENTATIONS

Presentations

  • “An Approach to Process Optimization in the Pharmaceutical Industry using a System based on the HACCP Concept,” ACS Pittsburgh Conference, New Orleans, LA (3/95)
  • “Considerations and Trends in Technology Transfer,” ACS Pittsburgh Conference, New Orleans, LA (3/95)
  • “Reinvestigation of the Larvicidal Activity of Marigold Oil,” with M.M. Green, D.J. Sutherland, and C.R. Hibben, 199th ACS National Meeting, Boston, MA (4/90)
  • “Simple Conversion of a Packed Column Gas Chromatograph to Wide Bore Capillary Operation,” with M.J. O’Hare, C.R. Rehm, and J.E. Zarembo, 190th ACS National Meeting, Chicago, IL (9/85)
  • “Gas Chromatographic Analysis of Ethylene Oxide Residues for Pharmaceutical Applications,” with M.J. O’Hare, C.R. Rehm, and J.E. Zarembo, ACS Pittsburgh Conference, Atlantic City, NJ (3/84)
  • “Problems and Interferences Affecting the Analysis of Chlorinated Pesticides and PCBs in Environmental Samples,” with A. Schoffman, ACS Pittsburgh Conference, Atlantic City, NJ (3/83)
  • “Problems, Demons and Gremlins Associated with the Analysis of Chlorinated Pesticides and PCBs,” Analytical Chemistry Symposium, CUNY Graduate Center, New York, NY (11/81)

Publications

  • “Validation of Laboratory Information Systems” with Alex M. Zislin amd Rory Budihandojo in Validation of Pharmaceutical Processes, Third Edition, Ed by J. Agalloco and F. Carleton, InformaUSA, Sept. 2007.
  • “Larvicidal Activity of Tagetes Minuta (Marigold) Towards Aedes Aegypti,” with M.M. Green, D.J. Sutherland, and C.R. Hibben, Journal of the American Mosquito Control Association Vol. 7, No. 2 (1991): 282-286.
  • Investigation of the Mosquito Larvicidal Activity of the Oil of Marigolds, Doctoral Thesis (1987)
  • “Relative Retention Time Calculation in Accordance with EPA Method 608,” Perkin-Elmer Sigma Basic Software Note CCCSN-10400 (1982)
  • Adsorption of Phosphorus in Silica Gel as Influenced by Treatment with Trimethylchlorosilane: To Develop a Suitable Diluent for Fine Textured Soils, Master of Science Thesis (1976)
  • “Quantitative Spectrophotometric Determination of Chloride Ion in Rainwater and Snow, Nucleus Journal of Science IX (1971): 10

Mike Spears


Consultant


Professional with solid technical and compliance knowledge, skilled in research and development, manufacturing, operations, validation, and quality engineering. Broad experience gained working over twenty years with pharmaceutical, device and biologics manufacturers. Background in the manufacture of solid dosage, liquids, creams and ointments, Class I and II medical devices (cardiovascular, urological, and reconstruction  products), with knowledge of a broad range of manufacturing and packaging equipment, including stirrers, mixers, fillers, washers, sealers, granulators, compression, Glatt and spray dryers, SIP systems, purified water systems, storage tanks, and high speed pumps, etc.

CORE COMPETENCIES

  • R&D/Design Controls
  • Design Changes/DHFs/DMRs
  • Specifications/Drawing Analysis
  • Risk Management /FMEAs/Hazard Analysis
  • Audits/Gap Analysis/Remediation
  • Quality Engineering/ Quality Assurance
  • Project Management/Tech Transfers
  • Process Improvement/Quality Initiatives
  • Cleaning/Sterilization/Validation
  • ISO 9000/ISO 13485/ISO 14971
  • 21 CFR Part 11/GAMP 5
  • 21CFR Parts 110/210/211/801/803/820
  • Recalls/Complaints/CAPA/Root Cause
  • Quality Plans/Manufacturing Plans
  • Biocompatibility Reports
  • Labeling/Storage/Handling
  • Package Sealing/Methodologies
  • Material Specifications/Components Instruments/CTQ attributes
  • Supplier Specifications/Audits/Monitoring
  • Purified Water Systems
  • Facilities/Commissioning/Utilities Environmental Monitoring
  • Change Control/Authoring/Reviewing
  • Inspections/1st Article
  • Start-Up/Sampling/Line Clearance

SELECTED ACCOMPLISHMENTS

  • Served as Director/Project Manager for fortune 500 company, consolidating three manufacturing facilities in to two major divisions, including:
    • Conducted Quality Audits at three facilities prior to Tech Transfer activities
    • Directed multi Pharmaceutical/OTC client sites with specific oversight over Quality Reviews, cGMP’s, Canadian Drug Laws and FDA compliance adherence, Quality Review and CAPA authoring
    • Managed staff of Project Managers and developing project timelines through Microsoft Project
    • Served as representative for FDA inspections
  • Served as project manager on development and validation of new laboratory and commissioning vaccine facility
  • Project managed validation of medical device manufacturers
  • Authored Risk Management, DFMEA, AFMEA and PFMEA documentation for Class I, II devices
  • Conducted DHF audits and remediation activities in support of FDA, EMEA and LAPAC governing bodies
  • Served as team member in design development and launch of new product lines for Recon Division
  • Conducted GAP analysis for medical device, pharmaceutical and biotech industries
  • Served as divisional QE/QA representative for design control/product realization activities including but not limited to classification of quality characteristics, design inputs and review, technical drawings and specifications, design verification and reliability and maintainability
  • Authored reports for third party contract manufactures
  • Reviewed and edited, test methods, labeling, sterilization and packaging documentation
  • Implemented and managed product quality programs, including component qualification, inspection and test methodologies, supplier qualification, developing and maintaining the quality plans, reviewing gauge R&R studies, test methods, preventative maintenance and calibration programs
  • Served as team member involved in establishing quality system (QSIT) in Medical Device facility
  • Represented quality assurance in tasks of development and manufacturing to ensure process capability and quality tools and systems are compliant prior to product launch.
  • Provided input into development studies, IQ/OQ/PQ validation plans, deviation reports (root cause analysis), and protocols as necessary
  • Ensured test plans/test protocols met ANSI/AMMI and ISO Standards per test methodology
  • Supported change control for existing products through review of engineering reports, drawing changes, supplier evaluations, review of biocompatibility and Bio burden analysis and design change paperwork
  • Defined, selected, and applied various techniques including supplier qualification, certification, evaluation, ratings, performance improvements for development and selection of suppliers during the product development process
  • Served on product complaints handling, Health Hazard Evaluations (HHE) and product recalls team
  • Authored biocompatibility documents for Recon product lines (components and instruments)
  • Reviewed and approved change requests through the Wind-chill PDM System, Blue Mountain and SAP, CAPA initiation, review and approval, quality audits, and Class II Atrial Fibrillation Systems
  • Developed process validation protocols and validation of medical device molding processes
  • Performed quality assessment of manufacturing deviations (determining/addressing root cause)
  • Performed deviation writing, review and approval
  • Initiated CAPA review and approval, and complaint handling training
  • Coached investigational staff on investigations, deviation writing and root cause analysis
  • Developed and authored equipment and environmental development studies (vaccines, solid dosage), technical studies, installation and operational protocols, deviation authoring and final reports for equipment in vaccine production, i.e., MES upgrade to weighing stations, (BMS) building and maintenance system validation (Software Validation, Risk Assessment, 21CFR Part 11 GAMP) communication point relocations and vial filler line validation.
  • Developed and wrote cleaning validation protocols and final reports for tunnel washer equipment used in the production of vaccines, i.e., stir bar assemblies, equipment, etc.
  • Performed clean room qualification and commissioning documentation review, CAPA and qualification (OQ and PQ executions for environmental air flows and sampling) environmental packaging equipment (fillers, vile washers, check weight equipment) building management systems (BMS), and HVAC and deviation authoring
  • Developed, authored, and preformed quality engineering review for IQ, OQ protocols final reports and deviations for medical device equipment, i.e., automated assembly machines, Software Validation, Risk Assessment, 21CFR Part 11 (GAMP), swaggers, data acquisition equipment, visions systems, induction heat sealers, Branson Welders, device sealers, leak testers, breakaway testers and Imtran printers at two facility sites (Indiana and New York)
  • Performed software validation for automated assembly machine, data acquisition equipment, welders, sealers and printers
  • Led project team for on time delivery of project documentation essential to compliance initiative
  • Performed quality review of batch records, non-conforming product, test tethods, IQ, OQ and PQ protocols (deviations) for team
  • Authored changes to Master Validation Plans (MVP) and Master Validation Reports (MVR)
  • Authored and reviewed final reports for multi validation projects
  • Reviewed and completed ergonomic profiles for manufacturing equipment
  • Provided client with innovative solution to meet compliance standards for drug storage
  • Reorganized environmental functionality to determine feasibility of upgrades to design
  • Implemented solutions for problems relating to architectural design during quality laboratory upgrade
  • Organized processes and resources to implement corrections to secure validated and operational facility
  • Designed and implemented project plan to ensure on time delivery of validation processes of new $50 mil manufacturing facility for solid dosage
  • Worked with project engineers and designers on commissioning validation processes
  • Authored IO,OQ,PQ deviation results for validation protocols for manufacturing equipment i.e., continuous coater, Human Manufacturing Interfaces (HMI), tablet compressors, laboratory equipment; water systems, laminar hoods, HVAC monitoring, and low humidity room, and packaging equipment, line clearance; metal detectors, cappers, induction heat sealers, counters, software, and vision systems.
  • Performed software validation of packing line equipment
  • Performed quality engineering review for CAPA, IQ, OQ, and PQ documents and reviewed and corrected P&IDs for manufacturing facility, i.e. HVAC, Water and Steam systems
  • Performed clean room validation, cleaning validation for vaccines, laboratory validation (LIMMS use)
  • Trained senior management personnel on authoring SOPs and work instruction procedures for their departments
  • Designed and conducted cGMP training program for bi weekly and hours employees
  • Participated in project update meetings with senior management

PROFESSIONAL EXPERIENCE

  • Integra Life Sciences, Quality Engineer (contractor for Pharma Bio Services) – 2012 to present
  • St. Jude Medical, Quality Engineer (contractor for The Experts) – 2011 to 2012
  • Sandoz Pharma, Quality Engineer (contractor for Black Diamond Network) – 2011
  • DPT Laboratories, Validation Engineer (contractor for Technical Staffing Group) – 2010
  • St. Jude Medical, Validation Engineer (contractor for RCM Technologies) – 2009 to 2010
  • Aventis, Validation Engineer (contractor for TechSource) – 2009
  • Wyeth, Validation Engineer (contractor for Integrated Project Services) – 2007 to 2008
  • American Technical Consultants, Director of Operations – 1998 to 2007
  • Barr Laboratories, Manufacturing positions, Solid Dosage – 1995 to 1998
  • Warner Lambert, Manufacturing positions, Solid Dosage – 1993 to 1995
  • Schering Plough, Mfg. and R&D positions, Solid Dosage, Liquids, Creams, Ointments – 1973 to 1993

EDUCATION

  • BS Management Science, Rutgers University – May 1991

TRAINING

  • Quality System Training – 2011
  • Complaint Handling Training – 2011
  • Blue Mountain Software & SAP – 2010
  • Kepner Tregoe Problem Solving and Decision Making Course
  • Ethnics in Business Program – 1989
  • Labor Management – 1990
  • Professional Trainer Certification – 1990
  • Glatt Air Drying School – 1989
  • Tablet Manufacturing Techniques – 1982
  • ISPE, IVT, Training Classes – 1998, 1999, 2005

AFFILIATIONS

  • ISPE [International Society of Professional Engineers]
  • PMI [Project Management Institute]
  • AMA [American Management Association]

Traci Van Arsdale


Consultant


Professional with strong experience in quality assurance, regulatory affairs, program management, and laboratory management. Highly credentialed with years of experience in top drug, biologics, and medical device manufacturing industries. Background in biologic/drug/device combination products (topicals, transdermals, inhalers, pre-filled pens and cartridges, and implants), biologics, sterile drug products, and solid oral dosage forms (solutions and suspensions), over-the-counter drug products, pumps, patches, nebulizers, and various other medical devices (sterile and nonsterile), including software-controlled devices.

 

CORE COMPETENCIES

  • Quality Assurance/Quality Control
  • Purchasing Control/Supplier Control
  • Quality Engineering/Regulatory Affairs
  • CAPA/Root Cause Investigation
  • Design Control/Design History Files
  • Management Review/Medical Device Reporting
  • Project Management/ Technical Writing
  • 21 CFR Parts 4/210/211/803/820
  • Corrective Action/Preventive Action
  • Risk Management/FMEA/Hazard Analysis
  • Change Control/Change Management
  • Quality Systems/Procedural Development
  • Pre-Approval Inspections/Audits
  • Council Directive 93/42/EEC
  • ISO 13485/ISO 14971
  • Process Improvement/Quality Initiatives

SELECTED ACCOMPLISHMENTS

  • Managed device-related pre-approval readiness activities for two drug-device combination products, including:
    • Led design reviews and risk management reviews.
    • Prepared design history file (DHF) indices
    • Conducted retrospective review of product design history files and completed compilation of associated DHF records.
    • Completed retrospective investigation, resolution and documentation of unresolved quality issues.
  • Managed various project activities for pre-commercial drug/device manufacturer implantable product, including:
    • Led internal writing and review process for New Drug Application, Chemistry, Manufacturing and Controls (CMC) modules for two products; identified drug and device-specific content gaps, participated in risk assessment and supported identification and implementation of remedial actions to ensure FDA approval.
    • Led internal writing and review process for Investigational New Drug (IND) Annual Report and CMC amendments to support device modifications for to-be-marketed (TBM) product.
    • Co-developed device usability study protocol for TBM.
    • Supported preparation of Pre-NDA meeting briefing package and meeting rehearsals for meeting with CDER and CDRH.
    • Authored and implemented quality system procedures for design controls, risk management, purchasing controls, quality audits, management review, medical device reporting, CAPA, complaint handling, and handling of recalls in compliance with applicable 21 CFR Part 4, 210/211, 803 and 820 regulations. –
    • Audited DHF and provided guidance in addressing compliance gaps.
    • Provided support for conducting investigations of out-of-specification product.
    • Provided support for design and implementation of device-specific stability studies.
    • Served as member of combination risk management team, and draft final labeling review team.
  • Managed remediation activities involving approved drug products, subject to FDA consent decree for multi-national pharmaceutical company, including:
    • Led process validation assessment, and retrospective validation strategy development and implementation for all commercial products, subject to FDA review.
    • Ran re-engineering of batch record review and lot release procedures, leading to cessation of third party batch release as part of consent decree.
    • Directed re-engineering/process improvement efforts for design of master batch records for bulk manufacturing and packaging and labeling operations.
    • Headed re-engineering/process improvement of analytical laboratory operations.
  • Served as process validation, independent third-party independent assessor for multi-national pharmaceutical company under FDA consent decree, subject to FDA review.
  • Provided quality and regulatory support for biologic/drug/device manufacturer, from Phase 1 through Phase 3 clinical development, including:
    • Resolved Complete Response Letter (CRL) issues pertaining to Phase 2 analytical method validation for biological assay.
    • Established and implemented drug-specific quality systems to address 21 CFR Parts 210/211.
    • Conducted device constituent design verification and design validation testing.
    • Prepared and submitted device master file (MAF) for device constituent. – Audited contract manufacturers, suppliers, clinical research organizations, and clinical sites.
    • Completed CMC IND Amendments to support drug substance (DS) and drug product (DP) changes, including site change, process changes, formulation changes, specification changes, and analytical method changes.
    • Served as member of CMC/product development team, supporting transfer and scale up of DS and DP manufacturing.
    • Provided support in obtaining State of CA facility license, including cGMP training and handling of inspections.
  • Led ISO 9001 registration and Medical Device Directive to allow CE marking of software-controlled device for a device and drug-device manufacturer, including:
    • Established quality manual and quality system procedures in compliance with 21 CFR Parts 4, 210, 211, 803, and 820.
    • Prepared and submitted device 510(K)s, Clinical Trial Applications (CTAs), and INDs.
    • Served as program manager for inhalation drug/device combination product development, including Pre-IND meeting.
  • Served as Acting Quality Director and supported implementation of commercial procedures to support launch of biologic/device autologous product, including establishment of returned drug product and biologic drug product reporting systems.
  • Served as quality lead for pre-approval readiness, quality system improvement initiative for a drug/device manufacturer of a software-controlled inhalation product, including: ­
    • Audited quality systems and conducted gap analysis. ­
    • Planned and implemented corrective actions. ­
    • Established design control, risk management, management review, CAPA, label control, master production record, and re-design of format and content procedures.

PROFESSIONAL EXPERIENCE

  • Medicines360, RA/QA Consultant – 2013 to 2014
  • SteadyMed, QA Consultant – 2013 to 2013
  • Christine Flahive Consulting, Consultant – 2009 to Present
  • Alexza, QA Consultant – 2008 to 2010
  • LexaMed Consulting, Consultant – 10/2007 to Present (Client Projects: AAP, Merck, Watson, Eli Lily, Dendreon)
  • Signature Therapeutics, QA Consultant – 2007 to Present
  • Revance Therapeutics, RA Consultant – 2007 to Present
  • Intermmune, Sr. Director, CMC Regulatory Affairs – 2006 to 2007
  • Titan Pharmaceuticals, Sr. Director, Quality – 2004 to 2006
  • Alpharma, QA Consultant – 2002 to 2004
  • Aerogen, Sr. Director, Quality/Regulatory, Program Management – 2000 to 2002
  • Cholestech, QA Consultant – 1999 to 2000
  • Shaklee Corporation (Yamanouchi Shaklee Pharma) Compliance Officer – 1998 to 1999
  • InSiteVision, Sr. Director, Quality/Regulatory – 1996 to 1998
  • Syntex, Manager, Quality – 1993 to 1996
  • Genentech, Sr. Quality Specialist -1991 to 1993
  • Johnson & Johnson, Sr. Quality Specialist -1988 to 1991
  • Shaklee Corporation, Microbiology Laboratory Manager – 1979 to 1988

EDUCATION

  • Bachelor of Science, Microbiology, South Dakota State University – 1979
  • Master of Business Administration, Golden Gate University – 2002

CERTIFICATION

  • Certified Quality Engineer (CQE), American Society of Quality – 1988
  • Certified Quality Auditor (CQA), American Society of Quality – 1990

AFFILIATIONS

  • American Society for Quality (ASQ), Former Fellow member (2003). Former Certification Board Member; Quality Engineering Certification (CQE) – former exam chair (1995 to 2000).
  • Malcolm Baldrige National Quality Award (MBNQA) for Performance Excellence; Former Senior Examiner; Team Leader; Feedback Writer.
  • Itnl. Standards Organization (ISO), Former US voting member; ISO quality management standards.

PUBLICATIONS AND PRESENTATIONS

  • American Society for Quality (ASQ), Quality Audit Division, Annual Conference. Speaker, Quality Management Systems.

Eliot Zaiken, CQE, CQA


Consultant


Results-driven medical device professional with extensive background and experience in design controls, Risk Management, DHF preparation, audit, and remediation, project/program management, and product design/development for global medical device companies. Background in coated urological catheters, IV drug pumps and tubing sets, combo syringe-drug devices, vascular and obstetric catheters, safety syringes and pen needles, mechanical and electro-mechanical blood pressure monitoring devices, mechanical and electronic stethoscopes, laser ablation catheters and lasers, ex-vivo blood flow technology, mechanical heart valves, combination products and IVD equipment and reagent filling processes.

CORE COMPETENCIES

  • DHF Remediation
  • Risk Management/FMEA/FTA/Hazard Analysis
  • Design History Files
  • DHF Remediation/Gap Analysis
  • Design Controls/Outputs/Reviews
  • Traceability Matrices
  • Project/Program Management
  • Product Development/Design
  • Design Drawings/Design Specifications
  • Design Verification/Validation
  • Material/Component/Supplier Specifications
  • Operating Procedures/Work Instructions
  • Set-Up/Start-Up Procedures
  • Process Development/Process Controls
  • Process Validations (IQ/OQ/PQ)
  • Process Capability
  • Voice of Customer/Market Research
  • Customer Requirements
  • Equipment Specification/FAT
  • Change Management
  • Inspection Procedures/Test Methods
  • Sampling Techniques/Sampling Plans
  • Critical Parameters/Critical Quality Attributes
  • Data Analysis/Statistical Analysis
  • ISO 9000/ISO 13485/ISO 14971
  • 21 CFR Part 11/21 CFR Part 820
  • Clinical Monitoring
  • Packaging Validation
  • Tolerance Analysis

SELECTED ACCOMPLISHMENTS

  • Lead role in the remediation of legacy combination product design history files
    • Remediation of over 30 combination products including oral solutions, transdermal patches, eye drops and IV products with various delivery devices (e.g. dosing spoons and cups, dropper bottles, medicine droppers)
    • Development and authorship of over 30 design history files and traceability matrices
    • Authored and facilitated design, process, and user FMEAs for numerous products
    • Development and authorship of risk management and risk benefit analysis for over 30 products
    • Developed and performed training for risk management process in accordance with ISO 14971
    • Lead design reviews for all products ensuring compliance with regulatory and internal standards
  • Completed design and development work for combination product manufacturer (drug-device), including:
    • Served as independent reviewer for all ISO 13485/ 21 CFR 820 design reviews on combo syringe-drug device
    • Lead project team for design and development of a hydrophilic urological coated catheter
    • Lead project team for remediation of quality issues related to IV drug pumps and tubing kits
    • Co-authored and facilitated user, design, and process FMEAs
  • Managed/assembled Design History Files for manufacturer of multiple devices, including
    • Managed/assembled DHF for coated urological catheter from concept thru design verification
    • Managed/assembled DHF for new Intrauterine Pressure Catheter from concept thru commercialization
    • Managed/assembled DHF for new Dual Helix Fetal Scalp Electrode from concept thru commercialization
    • Managed/assembled DHF for new Safety Pen needle from concept thru design verification
    • Managed/assembled DHF for mechanical sphygmomanometers
  • Performed multiple DHF gap analyses for medical device manufacturer of medical lasers and laser ablation catheters, including:
    • Performed in-depth gap analysis of Quality System for compliance to 21 CFR part 11 and ISO 13485
    • Performed DHF gap analysis for multiple laser ablation catheters
    • Performed DHF gap analysis for medical lasers for compliance to IEC 60601-1, IEC 60601-2, and IEC 60825-1
    • Assembled Software Traceability Matrix and identified gaps for adherence to IEC 62304
    • Performed design transfer gap analysis to internal design controls from transferring manufacturing of medical laser from UK to US
    • Audited risk management documents for compliance to ISO 14971
  • Assembled multiple retroactive Design History Files for manufacturer related to legacy devices, including
    • Updated/created DHF for Intrauterine Pressure Catheter
    • Updated/created DHF for Neonatal Catheter Insertion Device
    • Updated/created DHF for Single Helix Fetal Scalp Electrode
    • Assisted in updating/creating DHF for pen
  • Authored and conducted training for Design Control SOP for manufacturer, including:
    • Authored numerous internal design control SOPs in accordance with ISO 13485, ISO14971, and 21 CFR 820 for IVD devices
    • Conducted training for numerous Design Control SOPs for IVD devices including phased development system, risk management and analyses, and process validation
    • Conducted training in planning, facilitation, and execution of risk analyses including PHA, FTA and FMEA
    • Conducted training in planning, facilitation, and execution of process validation for process validation including IQ, OQ, and PQ
  • Managed various project activities for medical device manufacturer of urological catheters, including:
    • Led product development project team overseeing activities in R&D, Quality, Marketing, Regulatory, Operations, and Finance, including budgeting and scheduling responsibility, and successful 510(k) clearance (K112137)
    • Resolved and diffused team dynamic and personality conflicts that existed between several team members
    • Wrote equipment specifications for various automated equipment (60ppm), including dipping and punching equipment
    • Developed protocol and performed Factory Acceptance Testing (FAT) for automated equipment
    • Completed successful design transfer of automated manufacturing equipment from USA to international manufacturing locations
    • Developed test methods and characterized tensile behavior of catheters made from different materials
    • Resolved quality issue of leaking two-part molded valve resulting in mold changes
    • Trained junior engineers in design controls, statistical techniques, technical/design reviews, risk management, verification and validation activities, and FMEA
    • Developed innovative design for intermittent urological catheter leading to multiple patent applications
  • Managed various project activities for medical device manufacturer of safety pen needles and syringes, including:
    • Led product development project team overseeing activities in R&D, Quality, Marketing, Regulatory, Operations, and Finance including budgeting and scheduling responsibility
    • Wrote equipment specifications for various automated equipment (300ppm), including printing and packaging equipment
    • Performed Factory Acceptance Testing (FAT) for automated packaging equipment
    • Completed product development and design for safety pen needles resulting in multiple patent submissions
    • Lead team in development of process FMEA for automated equipment
    • Developed pilot molding strategy for building/implementing six 8-cavity steel molds from off-shore vendors to support design verification and clinical trials
    • Supervised mechanical engineers and design engineers in development of medical devices
    • Assessed, designed, and presented to management multiple device business opportunities with external pharmaceutical partners
    • Led training for design controls, statistical techniques, including sample size determination, and verification/validation activities to R&D staff of over 15 members
    • Led planning and implementation of VOC activities, including interviews and focus groups
    • Facilitated Intellectual Property Review Board committee for strategy/decisions for filing patents and/or holding IP as trade secrets
  • Managed various project activities for medical device manufacturer of obstetric catheters and devices, including:
    • Led product development project teams for multiple products resulting in three product launches
    • Developed/maintained risk analyses, dFMEA, design inputs, traceability matrix, and verification \validation activities
    • Performed process validation for elastomeric over-molding process
    • Managed external 3rd party suppliers and vendors in the design, development, and validation of cabling systems to connect developed disposable devices with existing fetal monitors in hospitals
    • Designed software algorithm to allow one-circuit board to meet needs of three different cabling systems
    • Performed supplier audits for electro-mechanical components
    • Designed and developed innovative test methods to simulate clinical use of devices in fluid environments
  • Managed various project activities for medical device manufacturer of stethoscopes and blood pressure monitors, including:
    • Led global product development with team members in three locations to support 510(k) clearance (K012455) and launch of shockproof mechanical blood pressure gage
    • Developed and validated semi-automated process to attach shockproof molded bumper to mechanical blood pressure gage
    • Resolved quality issues on manual production line including selecting proper adhesive and process flow improvements
    • Designed, developed, and tested thermoformed packaging tray for cardboard shelf box to meet ISTA standards
    • Resolved quality issues and streamline design of molded disposable stethoscope resulting in $200k savings per year
    • Developed and validated testing methodology for incoming inspection of electronic stethoscopes
    • Performed supplier audits on molded and extruded components
  • Managed various project activities for medical device manufacturer of ex-vivo blood separation devices, including:
    • Designed multiple sterile high volume disposable injection molded components for blood flow separation, including flow restrictors and rectangular channel connectors
    • Resolved quality issues with multi-lumen PVC tubing eliminating delamination
    • Designed and validated peristaltic pump blood delivery systems and software algorithms for blood flow separation procedures resolving accuracy issues
    • Coordinated and performed clinical monitoring at international Sites (Western Europe), including development of clinical protocols and clinical database management
    • Acted as key member of technical staff and liaison to field service to help resolve technical issues in real time

PROFESSIONAL EXPERIENCE

  • QSN – Remediation Consultant – 10/14 – present
  • Canon Life Sciences – Quality Engineer Consultant (Rockville, MD) – 03/13 to 10/14
  • Hospira, Program Manager -Contract Consultant (Lake Forest, IL) – 08/12 to 02/13
  • Quality Solutions Now, Inc., Consultant (Emmaus, PA) – 07/12 to present
  • Angiodynamics, Quality Engineer-Contract Consultant (Marlborough, MA) – 04/12 to 08/12
  • Bard Medical, Senior Program Manager (Covington, GA) – 06/10 to 02/12
  • Becton Dickinson, Staff Engineer (Franklin Lakes, NJ) – 09/06 to 05/10
  • Tyco Healthcare/Kendall, Principal Engineer (Ludlow, MA) – 03/03 to 09/06
  • Welch Allyn, Sr. Project Engineer (Arden, NC) – 04/98 to 02/03
  • COBE Laboratories, Project Engineer/Clinical Monitor (Lakewood, CO) – 02/90 to 12/97 Self Employed,
  • Engineering/Quality Assurance Consultant (Denver, CO) – 04/89 to 10/91
  • COBE Laboratories, Biomedical Engineer (Lakewood, CO) – 02/87 to 05/89
  • International Volunteer, Global Organizations (Greece, Germany, UK) – 06/86 to 01/87
  • Shiley, R&D Project Engineer (Irvine, CA) – 06/84 to 05/86

EDUCATION

  • Master of Engineering in Mechanical Engineering, University of California Berkeley – 5/84
  • Bachelors of Science in Engineering Mechanics, University of Illinois Champaign/Urbana – 5/81

TRAINING

  • Certified Biomedical Auditor, ASQ – 12/16
  • Certified Quality Auditor, ASQ – 6/15
  • Certified Quality Engineer, ASQ – 2/14
  • Design Control Training, Canon Life Sciences – 2/14
  • Regulatory Environment and Submissions, Bard Medical – 2/11
  • Advanced Leadership Training, Becton Dickinson – 7/09
  • Six Sigma Green Belt Training, Becton Dickinson – 6/08
  • Quality Sampling Plans, Becton Dickinson – 3/08
  • CAPA Training, Becton Dickinson – 8/07
  • Design of Experiments, Tyco Healthcare – 2/05
  • Phase Gate Product Development, Tyco Healthcare – 8/04
  • Leadership Training, Center for Advanced Leadership – 4/02
  • Advanced Bonding Techniques, Henkel – 7/01
  • Statistical Process Control, COBE Laboratories – 3/90
  • Behavior of Plastics/Rheology, American Society of Plastics – 5/88

PATENTS

  • 8,109,883 – Cable monitoring apparatus – Granted 2/12 
8,801,673 – Safety Pen Needle Assembly Having Shield for Non-Patient End – Granted 8/14
  • WO2009102596 – Safety Needle Assembly
  • WO2009114762 – Safety Pen Needle Assembly w/ Shielding for Patient & Non-Patient Ends
  • US20110118667 – Hub Assembly Having A Hidden Needle For A Drug Delivery Pen
  • US20080177168 – ECG Lead Wire Organizer and Dispenser
  • US20080082024 – Signal replication medical apparatus
  • US20060073728 – Intrauterine Pressure Catheter Interface Cabling System

Steven Zilli, Ph.D.


Consultant


Senior Pharmaceutical Professional with over 35 years of diverse and progressive technical and compliance knowledge in R&D quality assurance, regulatory compliance, manufacturing, quality control, and packaging Experience working in start-up and leading global pharmaceutical companies. Background in tablets, extended release tablets, tamper resistant tablets, capsules, oral liquids, parenterals, soft gelatin capsules, transdermal patches, and buccal films.

CORE COMPETENCIES

  • FDA/DEA/International Agency Inspections/Remediation
  • External audits/Supplier Audits
  • PAI Readiness/ Mock PAI
  • Pharmaceutical QA/ Regulatory Compliance in commercial manufacturing and R&D
  • Validation (Process, Cleaning, Analytical Method, Computer, Equipment)
  • Failure Investigations/Root Cause Analysis
  • Corrective and Preventative Actions (CAPA)
  • Operations Management
  • Quality system Requirements
  • Technology Transfers
  • Training Programs/Records
  • CMC Review/Remediation

SELECTED ACCOMPLISHMENTS

  • Provided complete GMP /Quality Assurance coverage to start up contract Development Company and major pharmaceutical companies, including:
    • Provided GMP guidance to development teams.
    • Performed GMP audits of API, contract manufacturers, contract packagers, analytical labs, and excipient manufacturers.
    • Reviewed all GMP documentation for API, excipients, packaging components and finished product including: specifications, methods, batch records, packaging records, process validation, investigations, change controls, labeling.
    • Reviewed CMC sections for DMF, IND and NDA approval.
    • Wrote and reviewed SOPs needed by product development organization.
  • Managed multiple projects for major drug manufacturer of controlled substances, semisolids, novel dosage forms and solutions, including:
    • Acted as Interim Head Analytical technical support while retaining R&D QA responsibilities
    • Cohosted two FDA inspections with zero observations.
    • Provided manufacturing, equipment and facilities expertise as part of an audit team assembled to perform a for cause audit of the companies commercial sites.
    • Provided GMP and technical support to a variety of dosage forms from IND through NDA approval, including: tamper resistant extended release tablet containing a controlled substance, transdermal patches, a soluble buccal film, topical gels, and sterile products (IV and intramuscular).
    • Performed Mock Preapproval inspections.
    • Coordinated PAI readiness.
  • Directed multiple activities for a contract development/research and clinical/commercial manufacturing company providing services to pharmaceutical and biopharmaceutical companies, including:
    • Established all Quality systems
    • Hosted a FDA PAI, two other FDA inspections and multiple DEA inspections without observations.
    • Completed IQ, OQ and PQ of analytical equipment, manufacturing equipment, stability chambers, air handlers, computers, water systems, and clean compressed air.
    • Wrote or reviewed SOPs for cleaning, maintenance, calibration of equipment and facilities.
    • Provided GLP support to analytical testing of test articles.
    • Conducted training (this included formal GMP presentations and one on one on the job training in clinical packaging, USP concepts, inventory control, and manufacturing).
  • Led multiple efforts for drug/biologics manufacturer of innovative medicines, vaccines, biologic therapies, consumer care and animal health products, including:
    • Provided GMP support to Part 11 remediation of R&D.
    • Provided GMP support to a group formed to speed nominated development projects to IND filing.
  • Managed and provided GMP and technical support for high profile, no fail projects at a multinational Pharmaceutical company including:
    • Coordinated efforts between: analytical R&D, API Led GMP and technical remediation efforts at a single source API supplier (this required 6 months of onsite supervision of manufacturing, R&D, pharmaceutical R&D, commercial manufacturing, the contract site and corporate planning).
    • GMP responsibility for an AIDS drug through NDA approval.
    • Served as member of team to remediate warning letter deficiencies at Puerto Rican company site
    • Responsible for GMP aspects of the renovation of a commercial manufacturing and packaging site
    • Represented manufacturing on a team to reformulate a soft gelatin capsule.
    • Led technical transfer and launch efforts at a commercial manufacturing site to launch a new product
    • Hosted 5 FDA inspections, a MHRA inspection and multiple DEA inspections with no serious observations.
    • Provided GMP support to installation and validation of purified water systems.

PROFESSIONAL EXPERIENCE

  • Zilli Consulting, LLC, President (Chaddsford, PA) – 2013 to Present
  • Endo Pharmaceutical, Manager R&D QA (Chaddsford, PA) – 2007 to 2013
  • QS Pharms, Director Quality Assurance, (Boothwyn, PA) – 2002 to 2007
  • Merck, Senior GMP Compliance Administrator, (West Point, PA) – 2002 to 2002
  • DuPont Pharmaceutical, Senior Quality Assurance Scientist, R&D QA (Wilmington, DE) – 1995 to 2001
  • DuPont Pharmaceutical Senior Process Pharmacist, (Garden City, NY) – 1993 to 1995
  • DuPont Pharmaceutical Manager Regulatory Compliance, (Garden City, NY) – 1991 to 1993
  • DuPont Pharmaceutical Senior Scientist, Central Manufacturing Technology, (Garden City, NY) – 1990 to 1991
  • DuPont Pharmaceutical Section Supervisor Bulk Manufacturing, Chemical Processing, and Contract Manufacturing, (Garden City, NY) – 1986 to 1990
  • DuPont Pharmaceutical Supervisor Packaging, (Garden City NY) – 1984 to 1986
  • DuPont Pharmaceutical Supervisor Bulk Manufacturing, (Garden City NY) – 1981 to 1984
  • DuPont Pharmaceutical Chemist, Quality Control, (Garden City, NY) – 1979 to 1981

EDUCATION

  • Ph.D., Industrial Pharmacy, St. John’s University, New York, NY – 1989
  • MS, Industrial Pharmacy, St. John’s University, New York, NY – 1983
  • BS, Chemistry, Hofstra University, Hempstead, NY – 1978

AFFILIATIONS

  • American Chemical Society, 1974 – Present

PUBLICATIONS AND PRESENTATIONS

  • Zilli and Nash, “Mixing of Acetaminophen and Lactose in a V-Shaped Blender, An Example of a Total Mixture”, Pharmaceutical Engineering, vol. 12, pp 54 (1992)

Brette Travaglio


President and Principal Consultant


Professional with solid technical and compliance knowledge, skilled in product development, quality engineering, and regulatory affairs. Highly credentialed with years of experience in top global medical device, biologics, and drug manufacturers. Background in orthopedic implant, safety needle/syringe, fluid therapy, clinical nutrition, patient monitoring system, infusion therapy, venous access systems, regional anesthesia, and wound drainage medical device, combination, and drug products.

CORE COMPETENCIES

  • Design Controls/ DMADV/DFSS Methods
  • Risk Management/FMEA/Hazard Analysis
  • Process Development/Process Controls
  • Operating Procedures/Work Instructions
  • Inspection Procedures/Test Methods
  • Sampling Techniques/Sampling Plans
  • Project Management
  • Quality Engineering/Regulatory Affairs
  • Quality Control/Quality Assurance
  • Change Initiatives/Change Controls
  • Quality System Development/Support/Auditing
  • Training/Training Materials/Assessments
  • 21 CFR Parts 11/210/211/820
  • ISO 9000/ISO 13485/ISO 14971
  • Council Directive 93/42/EEC
  • SOR/98-282
  • Process Improvement
  • Six Sigma/Lean Manufacturing

SELECTED ACCOMPLISHMENTS

Managed various project activities for medical device manufacturer of products in gastroenterology, urology, surgery, pulmonology, gynecology, and otolaryngology.

  • Provided regulatory compliance support to R&D, Project Management, QA, Technical Writing, and Validation departments regarding design control activities in support of a web-based information management software solution, utilized to capture images and videos, and generate physician, nursing, and patient documents from captured data
  • Conducted DHF audits and supported FDA and ISO audits.
  • Supported risk management activities according to ISO 14971, including development of risk plans, completion of FMEA/hazard analysis, documentation of risk reassessment, implementation of process for verifying effectiveness of risk mitigations, and training.
  • Prepared appropriate documentation required to support why FDA field actions not required.
  • Conducted software validation of Excel-based risk assessment form, including preparation of user requirements, functional requirements, software risk analysis, and test cases.
  • Completed gap analysis to identify compliance issues; developed quality plans to address issues and align/prioritize corrective actions required by numerous sources of external audits.
  • Lead CAPA efforts to ensure implementation and closures according to schedules and tracking in CAPA database; developed supplier qualification and monitoring processes.
  • Revised sampling plan, DHF audit, product development, risk management, validation, and GDP processes, including SOP’s, work instructions, process maps, and forms; developed training materials/assessment tests, and conducted training for over 50 team members.

Facilitated numerous project efforts for high-profile pharmaceutical, biologics, and medical device manufacturer of products in cardiology, dermatology, gastroenterology, immunology, mental health, nephrology, neurology, oncology, rheumatology, surgery, and virology.

  • Led and managed Procurement, Package Engineering, QA Validation, and thermal qualification test laboratory team members responsible to evaluate replacement of old with new gel pack in various controlled temperature shipping systems; developed strategy for establishing equivalency based on statistical analysis of packaging material strength, puncture resistance, seal strength, and enthalpy, and worst case thermal testing, in place of full qualifications.
  • Led and managed Package Engineering and QA Validation team members to requalify existing controlled temperature shipping systems and qualify controlled temperature shipping systems for new drug/biologics products, including development of project schedule, planning/scheduling of work, preparation of agendas, facilitation of meetings with thermal qualification test laboratories in UK, Harleysville, and Chicago, preparation of minutes to track action items, mitigation of risks to timelines, and reporting of progress and risks to upper management and product launch teams.
  • Lead and managed Six Sigma team comprised of Package Engineering and QA Validation personnel to develop leveraging methodology using thermal mass, product weights, and specific heat to establish equivalency between previously qualified controlled temperature shipping systems for existing drug/biologics products and new products in place of full qualifications, which translated to $1M cost savings.
  • Utilized leveraging methodology to prepare technical justifications, component specifications, packaging instructions, and bills of materials, providing rationale for use of existing qualified shippers with new drug, biologics, and combination device products.
  • Completed gap assessment to identify compliance issues related to package engineering processes; developed schedule and lead team to address gaps; revised SOP’s, work instructions, and forms accordingly; coordinated associated training.
  • Facilitated team comprised of domestic and international members, including Project Management, Package Engineering, Manufacturing Engineering, and Production personnel, to install and qualify toploading packaging solution from Dividella in Schaffhausen, and associated secondary packaging for vials, syringes, and injector pens; developed plan, scheduled and conducted meetings, updated plan, and prepared minutes to track action items.
  • Facilitated team comprised of domestic and international members, including Project Management, R&D, QA, Package Engineering, Manufacturing Engineering, and Production personnel responsible for automation and secondary packaging technology required for processing and packaging prefilled glass syringes in Schaffhausan; maintained plan and prepared minutes to track action items.
  • Managed global team responsible for establishing raw material qualification and vendor change control processes; utilized six sigma tools, including project charter, project plan, SIPOC analysis, process mapping, voice of customer at Leiden, Cork, Puerto Rico, Raritan, Springhouse, Malvern, Radnor, and Horsham sites, and database for tracking cycle times.

Conducted gap analysis for start-up implantable medical device manufacturer of products in spine, orthopedics, neuroscience, and vascular surgery seeking FDA compliance and ISO 13485 certification; managed consultant responsible for process validations related to manufacturing of proprietary gel technology; conducted due diligence investigation using fault tree analysis and prepared technical report to support complaint record.

Conducted gap analysis for prescription warehouse company intending to establish drug repackaging and manufacturing operations, and compliance with FDA 21CFR Parts 210/211.

Established complete quality system for medical device manufacturer of products that provide for vascular access and reduction of infection related to catheter related blood stream infections; quality system audited by FDA with no Form FDA 483 observations or warning letters.

Led and managed numerous project efforts for medical device manufacturer of products in fluid therapy, clinical nutrition, patient monitoring system, infusion therapy, venous access systems, regional anesthesia, and wound drainage medical device.

  • Facilitated task reduction program to eliminate non-value-added inspection, reducing testing by 15%, and began transition of QC inspection to operator self-inspection.
  • Conducted root cause investigations of nonconforming product, complaints, corrective action notifications, recalls, etc., resulting in annual reduction of nonconformances by 30%.
  • Developed and implemented enhanced nonconformance system at 4 sites requiring methodical root cause investigations and implementation of corrective and preventative action based upon top 5 patient safety defects; improved deviation processes.
  • Implemented start-up inspection for label printing and packaging operations, reducing nonconformances by 14% from previous year.
  • Lead group in conducting daily MRB’s to expedite disposition of nonconforming material.
  • Developed and implemented new material control program to reduce number of nonconformances related to mixed product internally by 68%; improved product identification and traceability program to enhance compliance; developed and implemented new label control program, ensuring that all labels were reviewed/ controlled prior to effectivity.
  • Improved rework/reprocess system to better track activities for enhanced compliance.
  • Facilitated major initiative between Quality, Manufacturing, and Engineering departments to create a harmonized classification of defects to better align categories with patient safety, functional, and cosmetic defects at 5 sites; developed and implemented improved inspection plans in packaging and molding, reducing inspection based on process controls/historical data.
  • Implemented statistical charting programs (control charts and key performance indicators).

Managed various project activities for medical device manufacturer of needles and syringes.

  • Provided QE support to R&D, Manufacturing Engineering, Production, QC, and QA for $93M product launch, specifically related to drawings, specifications, contract manufacturing, critical dimensions/tolerances, OGP Smartscope inspections, measurement methods, Gage R&R’s, validations, process capability, and facilities for manufacture of prototype and finished products.
  • Managed team responsible for Six Sigma efforts, including implementation of customized reduced sampling plans leading to $200K annual savings and execution of verification trials for vision inspection systems leading to reduction in scrap of $50K annually.
  • Managed internal and supplier audit programs; conducted audits; trained auditors.
  • Reviewed water and environmental monitoring programs on monthly basis; managed investigations for failed test results; provided support for upgrade of DI/UF water systems.
  • Conducted product impact investigations related to out-of-calibration nonconformances and prepared technical documentation to support impacts; conducted complaints investigations.

Facilitated various project efforts for medical device manufacturer of products in orthopedics.

  • Completed establishment registrations according to 21CFR Part 807, device listings and premarket notification submissions, 510(k)’s, according to 21CFR Part 807, investigation device exemptions according to 21CFR Part 812, and premarket approval applications, PMA’s, according to 21CFR Part 814; coordinated biocompatibility studies, toxicology studies, and sterilization validations in support of 510(k) applications.
  • Prepared test protocols, conducted testing, and completed test reports related to design verification testing of prototype and finished product bioabsorbable implants and sutures, polyester sutures, and titanium implants based upon simulated bench and cadaver testing.

PROFESSIONAL EXPERIENCE

  • Quality Solutions Now, Inc., President (Emmaus, PA) – 10/04 to Present
  • B. Braun Medical, QC/QE Manager (Allentown/Bethlehem/Breiningsville, PA/Cherryhill, NJ) – 1/04 to 4/05
  • B. Braun Medical, QC Process Control Manager (Allentown, Bethlehem, and Breiningsville, PA) – 4/03 to 1/04
  • Tyco/Healthcare/Kendall, Senior Quality Engineer (Deland, FL) – 1/02 to 4/03
  • Tyco/Healthcare/Kendall, Quality Engineer (Deland, FL) – 3/01 to 1/02
  • Arthrex, Inc., Regulatory Affairs Specialist (Naples, FL) – 6/99 to 3/01
  • Naples Day Surgery, Quality Analyst (two Naples, FL sites) – 12/97 to 6/99
  • Naples Day Surgery, Client Relations Representative (two Naples, FL sites) – 1/97 to 12/97

EDUCATION

  • Master of Science in Industrial Engineering, University of Miami, Coral Gables, FL – 9/95 to 12/98
  • Master of Business Administration, University of Miami, Coral Gables, FL – 9/95 to 12/97
  • Bachelor of Science, Aerospace Engineering, Florida Institute of Technology, Melbourne, FL – 9/86 to 12/90

CERTIFICATION

  • Certified Six Sigma Green Belt (CSSGB), American Society of Quality – 6/10
  • Certified Quality Auditor (CQA), American Society of Quality – 12/02
  • Certified Quality Engineer (CQE), American Society of Quality – 12/01

TRAINING

  • Introduction to Medical Combination Products, Center for Professional Innovation & Education – 9/12 (1.4RU)
  • Software Development for Medical Device Manufacturing, Software Quality Consulting – 11/10 (1.2 RU)
  • Certified Six Sigma Green Belt Certification Preparation, American Society of Quality – 6/10 (3 RU)
  • International Conference on ISO9000, American Society of Quality – 3/10 (1.8 RU)
  • Understanding and Implementing the New ISO 13485 Standard, Excel Partnership, Inc. – 1/05 (1.4 RU)
  • QSR for Medical Devices, Excel Partnership, Inc. – 8/03 (1.4 RU)
  • Validation, Tyco/Healthcare/Kendall – 11/02 (2.4 RU)
  • Sampling Techniques, Tyco/Healthcare/Kendall – 12/02 (0.8 RU)
  • Lean Manufacturing, Colby Associates – 4/02 (4.0 RU)
  • Behavioral Interviewing, Tyco/Healthcare/Kendall – 1/02
  • Design of Experiments, Launsby Consulting – 7/01
  • Team Building, Competitive Solutions, Inc. – 6/01
  • Investigational Device Exemption, FDA – 12/00
  • Internal Quality Auditing, Excel Partnership, Inc. – 12/00
  • Major Testing Techniques for Plastics, ASTM – 12/00
  • Advanced Failure Mode and Effects Analysis (FMEA) for Medical Devices, University of Wisconsin – 10/00
  • E/M Testworks 3.0 (Material Testing Software), MTS Systems Corporation – 3/00
  • Failure Mode and Effects Analysis (FMEA) for the Medical Device, University of Wisconsin – 1/00
  • QSR for Medical Devices, Excel Partnership, Inc. – 10/99
  • ISO 9000 Internal Quality Auditor, ISOtec – 6/98

AFFILIATIONS

  • American Society of Quality (ASQ) (Member #01362884) – 7/00
  • Healthcare Businesswomen’s Affiliation (HBA) (Member #9912470) – 10/12
  • Regulatory Affairs Professionals Society (RAPS) (Member #09551147-0) – 10/12