Frances Brostrom Morris

Consultant

• (610) 462-4090
• info@qualitysolutionsnow.com

Experienced Senior QA Manager with 20+ years in Quality Assurance and Quality Control in GxP in pharma, biotech, clinical trials, medical device, and Cell and gene Therapy industries. Skilled in ensuring compliance with regulatory standards, Quality Management Systems, deviations, root cause analysis, CAPA, FMEA-Risk Assessment, investigations, change controls, driving continuous improvement, team management, analytical method development, early research and development, validation, and implementing Lean and Six Sigma tools. Certified Change Agent dedicated to delivering cutting-edge therapies while maintaining high quality and regulatory compliance.

CORE COMPETENCIES

• Quality Risk Management ICH Q9, 21 CFR
• Regulatory Response to Observations
• BLA Review and Approval
• Standard Operating Procedures/Work Instructions
• Project Management/Collaborative Leadership
• High-Performance Team Building
• Process Development/Process Controls
• Six Sigma, Lean Manufacturing/Laboratories
• Kaizen, Kata, 5 Whys, 5S, Fault Tree Analysis, Ishikawa Diagram
• Data Analysis/Trend Reports/Metrics
• Technical Writing/Protocols/Reports
• Deviation Management/CAPAs/Root Cause Analysis
• Quality Systems Auditing/Gap Assessment
• Sterility Assurance (FDA, EU GMP, 21 CFR)
• 21 CFR Parts 4/7/210/211/801/803/806/807/810/812/820
• ICH, ISO 9000/9001, ISO 13485
• Continuous Process Improvement
• Analytical Method Development ICH Q2R2, Q6A-Q6B, Q9, Q11, Q14

SELECTED ACCOMPLISHMENTS

• Inspection Readiness and Product Launch:
  Supported inspection readiness and launch teams for two CAR-T drug products (Abecma and Breyanzi) at Bristol Myers Squibb, ensuring compliance with global cGMP standards and corporate policies.
• Regulatory and BLA Submission Support:
  Provided quality oversight for clinical and commercial parenteral drug manufacturing, supported BLA regulatory review, and responded to FDA observations, achieving timely product release and regulatory compliance.
• Cost Savings Through Procedure Improvements:
  Drove operational improvements at Bristol Myers Squibb by implementing streamlined procedures, reducing turn-around times, and achieving cost savings through Six Sigma Lean Labs and FMEA-Risk Assessment for commercial operations.
• QMS Gap Assessment:
  Completed a 3-year contract at Merck in Luzern, Switzerland, performing a QMS gap assessment for Phase 2 clinical manufacturing of Keytruda, closing over 300 deviations and CAPAs, and preparing the site for FDA commercialization.
• Leadership in Quality Assurance:
  Recruited, managed, and mentored a team of 6 managers and 45 scientists to support the rapid expansion of operations at Bristol Myers Squibb, driving business continuity planning and maintaining compliance with global quality standards.
• Process Development and Risk Assessment:
  Led the development of quality management systems and risk assessments for early clinical phase manufacturing at the Gates Biomanufacturing Facility, ensuring compliance and successful project management for multiple clients.

PROFESSIONAL EXPERIENCE

• Bristol Myers Squibb – Senior Manager Quality Control Microbiology Operations (Jan 2022 – Jul 2024)
• Bristol Myers Squibb – Senior Manager Quality Assurance Operations (May 2019 – Dec 2021)
• Gates Biomanufacturing Facility – Quality Assurance Manager (Feb 2016 – Jun 2018)
• MSD (Switzerland) – Senior Quality Assurance Specialist (Aug 2012 – Jun 2015)
• Merck – Quality Assurance Specialist (Feb 2011 – Aug 2012)
• Professional Gap – Family emergency (Jun 2007 – Jan 2011)
• Amgen – Senior Quality Assurance Associate (contract) (Nov 2006 – Jun 2007)
• Pharmatech – Program Manager Clinical Trials (Mar 2006 – Nov 2006)
• Thermo Biostar – Formulations Supervisor (Jan 2004 – Mar 2006)
• Amgen – Senior Microbiologist (contract) (Jan 2001 – Dec 2003)
• Procter & Gamble – Senior Microbiologist Program Manager (Sep 1996 – Aug 2000)
• Professional Gap – Family planning (1993 – Sep 1996)
• Pace Foods – Microbiologist (Jul 1990 – Dec 1993)
• Virus Reference Laboratory – Microbiologist (Sep 1987 – Jul 1990)
• University of Texas Health Science Center – Research Associate (Aug 1982 – Aug 1987)

EDUCATION

• Master of Science (MS), Organizational Leadership – Colorado State University (Sep 2009 – May 2017)
• Bachelor of Science (BS), Biology/Chemistry – University of Texas (Aug 1981 – Dec 1992)

CERTIFICATION

• Certified Change Agent – Merck (Sep 2011)
• Yellow Belt – Merck (Jan 2012)

TRAINING

• Root Cause Analysis – Merck (2011)
• Six Sigma – Merck (2012)
• Comparative Analysis – Thermo Biostar (Jun 2004)
• Analytical Method Development
• Laboratory Information Systems
• Preparing for ASQ Certification for Quality Auditor

AFFILIATIONS

• Parenteral Drug Association (PDA) – Jan 2022
• American Society for Quality (ASQ)

Leonel Vanegas

Consultant

• (610) 462-4090
• info@qualitysolutionsnow.com

Accomplished Global Director of Quality Assurance with over 25 years of expertise in quality management, regulatory affairs, and commercialization of combination products and medical devices. Proven track record of managing quality assurance teams and driving compliance with FDA, ISO, and other global regulatory standards in the medical device and pharmaceutical industries. Expertise in drug delivery platforms (injectables, prefilled syringes, autoinjectors, electro-mechanical on-body delivery systems), Asthma inhalers, single-entity, co-packed, and cross-labeled combination products, laparoscopic devices, transcatheter heart valves, and drug-eluting stents. Proficient in regulatory frameworks, including ICH Q8-Q10, ICH E6(R2), and 21CFR Parts 4, 210/211, 803, 806, and 820. Bilingual in English and Spanish.

CORE COMPETENCIES

• Clinical Trial Quality Assurance
• Clinical Evaluation Plans/Reports
• Regulatory Compliance (FDA, ISO)
• Quality Management Systems (QMS)
• Risk Management & FMEA
• Process Development & Improvement
• CAPA, Change Control & Remediation
• Inspection Readiness for US and EU
• Auditing & Inspections
• Analytical Method Development and Validation
• Regulatory Submissions (INDs/BLAs/PMAs)
• Post-Market Surveillance
• Clinical Operations (GMP/GCP/GVP)
• Medical Devices and Combination Products
• Supplier Quality & Vendor Qualification
• Cross-Functional Leadership & Team Management
• Lean Six Sigma Methodologies
• Design Control & Validation

SELECTED ACCOMPLISHMENTS

• Cost Reduction and Lab Establishment: Led the initiative to establish, validate, and launch two internal labs for medical devices, adhering to FDA, EU, and ISO 13485 standards, saving $3M annually by reducing reliance on external testing facilities and minimizing poor quality costs.
• Global Compliance Improvement: Implemented and monitored quality management systems across global teams, achieving a 95% compliance rate with FDA and cGMP regulations, improving operational efficiency and audit readiness.
• Risk Mitigation Strategy Implementation: Spearheaded the creation of a Quality Risk Assessment framework, resulting in early identification of product risks and successful risk mitigation strategies, reducing deviations and CAPAs by 40%.
• GR&R Protocol Optimization: Achieved a $500K annual cost reduction by optimizing GR&R protocols for the measurement of tissue leaflets in heart valves, improving product reliability and decreasing production costs.
• Customer Complaint Reduction: Implemented iterative design changes for Enbrel legacy combination products, reducing unresolved customer complaints by 30% and improving product safety and user satisfaction.

PROFESSIONAL EXPERIENCE

• Precision Regulatory Consulting LLC – Founder (Aug 2016 – Present)
  • Developed and executed regulatory strategies for medical devices and biotech industries, resulting in the successful submission of 5 INDs and 3 BLAs.
  • Supported clients in regulatory filings, product development, and audit readiness, focusing on GCP, GMP, and GLP compliance.
  • Advised clients on complex regulatory compliance issues, resulting in a 15% increase in client satisfaction scores.
• Alexion Pharmaceuticals (AstraZeneca Rare Disease Unit) – Director, Corporate Clinical Product Quality (April 2020 – July 2024)
  • Managed global regulatory and quality strategies for biologics, medical devices, and combination products, aligning with cGMP standards.
  • Achieved 95% compliance in regulatory reporting and implemented quality frameworks that saved $3M through lab setup.
  • Ensured up-to-date regulatory intelligence, reducing device compliance risks by 50%.
• Alexion Pharmaceuticals – Director, R&D Quality / Expert Consultant (Sept 2019 – April 2020)
  • Developed EU MDR procedures and launched compliance courses for injectable combination products, contributing to IND and BLA approvals.
  • Led Device Quality Operations with oversight of GMP, GVP, and GCP for combination products.
• Merck & Co. – Director, Global QA – Devices and Combination Products (Feb 2017 – Aug 2019)
  • Directed global QA/RA strategies for vaccines and combination products, resulting in the successful launches of Gardasil 9® and Pneumovax 23.
  • Planned and executed DHF remediation efforts for 32 products, achieving FDA and ISO13485 compliance.
• Noven Pharmaceuticals – Director of Quality Engineering (Jul 2014 – Nov 2016)
  • Managed quality engineering, validation, and Lean Sigma training, overseeing the timely remediation of FDA 483 observations and improving audit outcomes.
• Amgen – Principal Device Quality Engineer (May 2012 – Jul 2014)
  • Led quality assurance for injectable products, achieving zero observations during FDA audits for Neulasta® and Repatha® launches.
  • Reduced unresolved customer complaints by 30% for Enbrel legacy combination products through iterative design changes.

EDUCATION

• Master of Science (MS) in Regulatory Affairs Science – San Diego State University, CA (May 2016)
• Master of Business Administration (MBA) in Global Management – University of Phoenix, Plantation, FL (June 2022)
• Bachelor of Science (BS) in Chemistry – Florida International University, Miami, FL (May 1997)
• Associate of Arts (AA) in Biology – Miami Dade College, Miami, FL (June 1993)

CERTIFICATION

• Certified Six Sigma Black Belt (CSSBB) – American Society for Quality (ASQ)
• Certified Quality Engineer (CQE) – ASQ
• Biomedical Auditor (CBA) – ASQ
• Certified Manager of Quality of Organizational Excellence (CMQ/OE) – ASQ
• EU Medical Device Regulation (EU MDR) Certified – MEDDEV

TRAINING

• “Statistical Methods for Quality Engineering” by Consulting Alliance Group
• “Design Control and Risk Management for Medical Device Industry” by Excel Partnership (Aug 2006)
• Certified Lean Sigma Black Belt at Medtronic and Johnson & Johnson (Jun 2008)
• “EU Medical Device Regulation (EU MDR)” by MEDDEV Solutions (Feb 2017)

AFFILIATIONS

• American Society for Quality (ASQ)
• Regulatory Affairs Professionals Society (RAPS)
• Parenteral Drug Association (PDA)
• International Society for Pharmaceutical Engineering (ISPE)

PUBLICATIONS AND PRESENTATIONS

• Vanegas, L. (2019). How Can Quality Help Drug-Device Teams Become Agile? Presented at 9th Ed. Injectables Summit, San Diego.
• Vanegas, L. (2020). How Quality Can Help Drug-Device Combination Teams Become Agile in Changing Regulatory Environment. Presented at Pre-filled Syringes East Coast Virtual Conference, SMi.
• Vanegas, L. (2022). Practical Applications of a Streamline Approach (21CFR part 4 – Subpart A) cGMPs of CPs in Pharma. Presented at 12th Edition Injectables Summit, Boston, MA.
• Vanegas, L. (2024). Test Method Validation Strategies of Prefilled Syringes. Presented in Boston, MA.

Brian Newbery

Consultant

• (610) 462-4090
• info@qualitysolutionsnow.com

A seasoned medical device quality system consultant with over two decades of experience in global quality systems and regulations. Expertise spans across medical devices from Class I to Class III, covering all parts of the product life cycle, including design, development, manufacturing, and post-market activities. Focused on helping start-up medical device companies fast-track their quality management systems to achieve certification and assisting with major QMS transitions, such as the FDA QMSR transition.

CORE COMPETENCIES

• Fast-Track Complete QMS Implementation
• Use of QMS Documentation Templates
• Gap Analysis and Implementation Planning
• ISO 13485:2016 Certification Support
• QMSR Gap Analysis and Transition Planning
• QMSR Transition Support
• Quality System Training and Coaching
• QMS Remedial Action Support
• Internal Auditing
• Process Verification and Validation
• Corrective and Preventive Action Process (CAPA)
• Design and Development Compliance
• Effective Quality Metrics
• Parametric Release and Improvements in Cost of Quality (CofQ)

SELECTED ACCOMPLISHMENTS

• Global Leadership and Team Management: Led global quality system teams across North America and Asia, managing quality operations in facilities ranging from small manufacturing plants to sites with over 2,500 employees.
• Proactive Quality Planning: Initiated, developed and implemented changes from a reactive to proactive quality planning and management approach. This resulted in significant improvements in product quality and reductions in the cost of quality as well as increased customer satisfaction. 
• ISO Certification Fast-Tracking: Working with start-up medical device facilities fast-tracked QMS implementation and achieved ISO Certification in 6 months.
• Industry Recognition and Awards: Chairman’s Science and Technology Award, Robotic System, Allegiance, Cardinal Health
• Patent Achievement: Design Patent Award for Bi-Directional Tractor Design, USA 1993

PROFESSIONAL EXPERIENCE

• Fast-Track QMS Consultants
  • Founder and Senior Consultant (June 2019 – Present)
• Cardinal Health
  • Director QA/RA, Rayong, Thailand (Feb. 2003 – May 2019)
• V. Mueller
  • Senior QRM Manager, St. Louis, MO, USA (Feb. 1998 – Feb. 2003)
• Ford New Holland
  • QA Manager, Winnipeg, Canada (1993 – 1998)
  • Product Design Leader, Winnipeg, Canada (1990 – 1993)

EDUCATION

• Higher National Certificate, Mechanical Engineering, Taunton College UK (July 1973)
• Mechanical Engineering Certificate, London Institute UK (June 1971)

CERTIFICATION

• Quality System Lead Auditor, General Physics Corporation (March 1995)
• Implementing a Quality Management System Compliant with ISO 13485 & MDD, TUV (June 2003)
• Certificate of Management, University of Manitoba (May 1995)
• Certification of Quality Management, University of Manitoba (May 1997)

TRAINING

• Lead Auditor Training & Certification, General Physics (March 1995)
• ISO 13485/MDD QMS Implementation, TUV (June 2003)
• SPC Tools, Cardinal in-house training (June 2010)
• Risk Management, Cardinal in-house training (Aug 2010)
• Design and Process Validation, Cardinal in-house training (April 2012)
• Lean Six Sigma, Green Belt and Project Sponsor training, Cardinal (June 2012)
• Concurrent Engineering, Ford New Holland (May 1995)

Scott DiDomenico

Consultant

• (610) 462-4090
• info@qualitysolutionsnow.com

Global life sciences project and change management leader with expertise in strategy and business portfolio acumen. Demonstrated ability to design, develop, and launch life sciences products and services within the medical devices, combination products, and pharmaceutical clinical trials industries. Additional experience in quality, procurement, and clinical supply chain management. Specific product experience includes fracture care implants and instruments as well as autoinjector and passive needle guard combination products.

CORE COMPETENCIES

• Design Controls/DMADV Method
• Risk Management/FMEA/Hazard Analysis
• Operating Procedures/Work Instructions
• Regulatory Submissions
• Technical Writing/Protocols/Reports
• Project Management
• Change Management
• Change Controls/CAPA
• Quality Systems Gap Analysis
• 21 CFR Parts 820.30
• ISO 9000/ISO 13485/ISO 14971
• Six Sigma Process Excellence
• 510k Submissions
• Leadership Development
• Workshop Facilitation
• Communication
• Continuous Improvement
• Operating Room Procedures

SELECTED ACCOMPLISHMENTS

• Project Management and Process Development: Led teams to design and develop processes and capabilities within the pharma industry, resulting in standardization and efficiency improvements.
  • Completed CMC responsibilities and led two early development small molecule neuroscience compounds through appropriate stage gates.
  • Improved unblinding processes in clinical trials.
  • Led numerous Continuous Improvement projects, including workshop facilitation and SOP development.
  • Developed and managed a 3-year roadmap for clinical trial negotiation, contracting, pricing, and payments.
  • Developed global capabilities post-Covid to aid in faster drug supply to patients.
• Pharma/Device Combination Product Design: Designed and launched various combination products, leading to significant sales volumes.
  • Adhered to 21CFR Part 820.30 for combination product design and development.
  • Executed verification and validation procedures, including drop testing and syringe liquid release to ensure proper dosages.
  • Updated risk management activities, including FMEAs and risk management summary reports.
  • Conducted Human Factors testing with healthcare professionals to develop proper usage and handling instructions.
• Orthopedic Implant and Instrument Design: Designed graphic cases and implants, resulting in high sales revenue for orthopedic implants and instruments.
  • Worked closely with product development engineers and top orthopedic surgeons to define and prototype designs.
  • Managed design, prototyping, and validation processes using CAD software and lean methodologies.
  • Attended surgeries to ensure the safe and effective use of implants and instruments.
  • Developed associated Design History Files and co-developed Technique Guides for surgical use.

PROFESSIONAL EXPERIENCE

• Johnson & Johnson, Innovative Medicine
  • Associate Director, Country Insights and Deployment Office (Remote) – 1/20 to 8/24
  • Associate Director, Contracts and Centralized Services (Remote) – 1/17 to 12/19
  • Senior Manager, Strategy & Process Improvement (Remote) – 1/14 to 12/16
  • Chemistry Manufacturing & Control Leader (Raritan, NJ) – 1/13 to 12/13
  • Quality Improvement Leader (Springhouse, PA) – 1/12 to 12/12
  • Senior Scientist, Primary Container and Device (Springhouse, PA) – 3/08 to 12/11
• DeVry University
  • Adjunct Professor (Fort Washington, PA) – 5/07 to 5/09
• Johnson & Johnson, Depuy Synthes
  • Sr. Product Development Engineer (West Chester, PA) – 1/00 to 2/08
• Neapco, Inc.
  • Product Development Engineer (Pottstown, PA) – 1/97 to 12/99
• JG Furniture
  • Product Development Engineer (Quakertown, PA) – 1/94 to 12/96

EDUCATION

• Master’s in Business Administration, Business, St. Joseph’s University, Philadelphia, PA – 9/97 to 5/03
• Bachelor of Science, Mechanical Engineering Tech., Temple University, Philadelphia, PA – 8/91 to 1/94
• Associate of Science, Mechanical Engineering Technology, LCCC, Schnecksville, PA – 8/89 to 5/91

CERTIFICATION

• Certified Rapid Learning Cycles Program Manager, Rapid Learning Cycles Institute – 12/09
• Certified Six Sigma Green Belt (CSSGB), American Society of Quality – 12/11 to Present
• Certified Leader in Flawless Process Execution (FPX), JNJ FPX – 6/13 to Present
• Certified in Problem Solving and Decision Making (KT), Kepner-Tregoe – 6/14 to Present

TRAINING

• AutoCAD, Autodesk – 1/94
• Pro/Engineer CAD, PTC Corporation – 1/00
• Orthopedic Sales Basic Training, Depuy Synthes – 1/04
• Cadaver Lab Procedures, Depuy Synthes – 2/04
• Operating Room Procedures, Depuy Synthes – 3/04
• Rapid Learning Cycles Program Management, Rapid Learning Cycles Institute – 12/09
• Six Sigma Yellow Belt, Johnson and Johnson Quality – 12/10
• Six Sigma Green Belt, Johnson and Johnson Quality – 12/11
• Six Sigma Black Belt, Johnson and Johnson Quality – 12/14
• Dale Carnegie Leadership, Johnson and Johnson Innovative Medicine – 8/17
• Leaders of Tomorrow, Johnson and Johnson – 12/21

AFFILIATIONS

• Society of Manufacturing Engineers – 8/92 to 1/94

PUBLICATIONS AND PRESENTATIONS

• Inventor listed on USPO US Patent #7,951,176, Bone Plate – 5/11
• Inventor listed on USPO US Patent #8,043,297, Aiming Arm for Bone Plates – 10/11
• Inventor on USPO US Patent #8,753,348, Compressor-Distractor – 6/14
• Inventor listed on USPO US Patent #10,653,466, Bone Plate – 5/20

Dipti Dharia

Consultant

• (610) 462-4090
• info@qualitysolutionsnow.com

A seasoned quality and regulatory professional with over 30 years of technical and compliance experience in global Medical Devices/Diagnostics, Pharmaceuticals, Combination Products, Consumer Products, Dietary Supplements and Foods industries. Strong combination of Quality Systems, Compliance, Regulatory, Clinicals, Quality Engineering, Engineering, Operations, Lean Initiatives, Product/Process Transfer & Commercialization, Contract Manufacturing, Validations, Customer Service, Project Management, Process Excellence (Black Belt certified), and acquisitions & divestitures experience. Demonstrated success in operating in stable and turnaround situations with global experience in both large company and smaller PE backed company environments.

CORE COMPETENCIES

• Quality Systems/Auditing/Gap Analysis/Quality Maturity Modeling
• Warning Letter Remediation
• Regulatory Submissions
• Design Controls/DFSS
• Risk Management/dFMEA/pFMEA/Hazard Analysis
• Usability Engineering
• Complaints Management/Adverse Event Reporting
• CAPA/NCs/Change Controls
• Investigations/Root Cause Determinations
• Recalls/Field Actions
• Standard Operating Procedures/Work Instructions
• Supplier Management/Supplier Quality
• Training/Training Curriculum/Training Materials/Assessments/Tracking
• Stability/Product Testing
• eQMS Implementation/Optimization/Training
• Process Development/Process Controls
• Post Market Surveillance
• Inspection Readiness
• Project Management/Leadership
• 21 CFR Parts 4/7/11/210/211/801/803/806/807/810/812/820/110/111/117
• ISO 9000/ISO 13485/ISO 14971
• EU MDR 2017/745
• FSMA/HACCP/New Dietary Ingredient
• Six Sigma/Certified Black Belt/DMADV

SELECTED ACCOMPLISHMENTS

• Developed and executed a comprehensive remediation plan to revamp Quality Management Systems in response to repeat FDA inspection observations, with a specific focus on Complaints/Medical Device Reporting, CAPA, Management Responsibilities, Change Controls, Design Controls, and Risk Management.
  • Documented CAPAs for repeat observations, defined problem statements, conducted root cause investigations, and developed action plans.
  • Created optimized Complaints Management & MDR processes, including process flows, procedures, and detailed work instructions.
  • Established a robust Change Control process covering both design changes and changes not impacting product design, including a checklist for impact assessment and various supporting forms.
  • Developed a streamlined Design Controls process, including procedures for hardware and software development, detailed work instructions, and forms/templates for all design control deliverables.
  • Created a Risk Management process in compliance with ISO 14971:2019, linked to Design Controls, Complaints, Post Market Surveillance, and Operations.
• Managed multiple workstreams to develop quality systems for compliance with EU MDR for a medical device manufacturer, including:
  • Creating and updating procedures, forms, and templates to support regulatory, clinical, design controls, risk management, post-market surveillance, quality systems, and economic operators.
  • Completing a gap assessment of technical files against EU MDR, leading to the submission of EU MDR applications for 22 product families and obtaining certifications.
  • Revamping clinical procedures, forms, and templates, and overseeing the preparation and submission of study documents for ethics approval.
• Guided a large quality team to remediate Major Non-Conformities and critical FDA findings for a medical device manufacturer of implantable medical devices, including:
  • Revamping the CAPA process, improving complaint management, and increasing CAPA and complaint timeliness significantly.
  • Revising training programs and non-conformance procedures to capture trending and risk management effectively.
  • Registering offsite product development offices as design facilities and ensuring audit readiness.

PROFESSIONAL EXPERIENCE

• Kendallton, LLC – President (Kendall Park, NJ) – 10/18 to Present
  Supporting numerous clients, including Intuvie LLC, Vytalogy LLC, Juvenescence, and CeQur Corporation.
• Corin Ltd. – Chief Quality, Regulatory, and Clinical Officer – 6/19 to 7/23
• Atrium Innovations – Chief Quality and Regulatory Officer – 10/14 to 12/18
• Johnson & Johnson – Various positions – 1/97 to 10/14
  • Customer & Logistics Services (CLS), Sr. Director – Quality Affairs (New Brunswick, NJ) – 4/14 to 10/14
  • Consumer Products Worldwide, Sr. Director – Business Quality (Skillman, NJ) – 1/11 – 4/14
  • Orapharma Inc., Director – Quality Affairs (Warminster, PA) – 4/09 to 12/10
  • J&J Consumer, Director – Quality Affairs (Skillman, NJ) – 8/07 to 4/09
  • Veridex, Director Operations/Product Support (7/06 to 7/07)
  • Veridex, Director Customer Quality (6/03 to 7/07)
  • Ortho-Clinical Diagnostics, Acting QA Manager (Raritan, NJ) – 2/03 to 6/03
  • Ortho-Clinical Diagnostics, Staff Quality Engineer – Quality Technical Operations (Raritan, NJ) – 4/02 to 6/03
  • Ortho-Clinical Diagnostics, Staff Quality Engineer – Product Support (Raritan, NJ) – 10/01 to 4/02
  • Ortho-Clinical Diagnostics, Senior Engineer – Product Support (Raritan, NJ) – 4/99 to 10/01
  • Ortho-Clinical Diagnostics, Verification & Validation Engineer (Raritan, NJ) – 7/98 to 4/99
  • Cordis, Sr. Manufacturing Engineer (Warren, NJ) – 1/97 to 7/98

• British Aerospace – GEC Marconi Electronics Systems – 9/93 to 1/97
• Alpha Wire Corporation (Elizabeth, NJ) – 3/92 to 9/93
• BF Goodrich – Simmonds Precision (Cedar Knolls, NJ) – 7/88 to 10/91

EDUCATION

• Master of Science, Information Systems, New Jersey Institute of Technology, Newark, NJ – 9/00 to 5/05
• Master of Science, Engineering Management, New Jersey Institute of Technology, Newark, NJ – 9/88 to 5/98
• Bachelor of Science, Industrial Engineering, New Jersey Institute of Technology, Newark, NJ – 4/83 to 5/88

CERTIFICATION

• Executive Quality Leadership Development (EQLD), Johnson & Johnson – 2012
• Certified Six Sigma Black Belt (CSSGB), Johnson & Johnson – 2003

TRAINING

• Best practices for engaging with the US FDA on HFE strategy and submissions, Emergo – 2024
• Conducting a Comparative Analysis in Lieu of HF Validation Testing, Emergo – 2024
• Medical Device Software and Cybersecurity, Emergo – 2024
• Proposed Rule Medical Devices; Quality System Regulation Amendments 21 CFR 820 – 2023
• MHRA, UK Road Map and Swiss Regulatory Updates, Emergo – 2023
• Claiming Equivalence Under MDR – Regulatory Considerations, BSI – 2022
• Understanding Risk Management with Medical Devices, FDA – 2022
• MDR Rule 14 Devices (Combination Products), BSI – 2021
• Clinical Evaluation for Medical Software & AI Devices, BSI – 2021
• UKCA for Medical Devices, BSI – 2021
• European Union Medical Device Regulation (EU MDR), TUV Sud – 2019 & 2020
• ISO 14971:2019, TUV Sud – 2020
• Extension to the MDR Transition Timelines – 2020
• Executive Quality Leadership Development (EQLD) –2012
• Crossing the Finish Line, Diversity and Inclusion Group, New Brunswick, NJ – 2010
• Project Management, Ortho-Clinical Diagnostics, Raritan, NJ – 2001
• 7 Habits of Highly Effective People; Learning Services, J&J Corp.- 2007
• Kepner Traego – Problem Solving Techniques; Learning Services, J&J Corp. – 2006
• Seven Steps to Finding Root Cause; ADVAMED – 2006
• Failure Modes and Effects Analysis (FMEA); Learning Services, J&J Corp. – 2008
• Design for Manufacturability/Concurrent Engineering; GEC Marconi, Wayne, NJ – 1997

Jitendra J. Balar

Consultant

• (610) 462-4090
• info@qualitysolutionsnow.com

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

• (610) 462-4090
• info@qualitysolutionsnow.com

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

• (610) 462-4090
• info@qualitysolutionsnow.com

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

Carolyn de Jonge

Consultant

• (610) 462-4090
• info@qualitysolutionsnow.com

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

• (610) 462-4090
• info@qualitysolutionsnow.com

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