Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
ID: 723903 North Carolina, USA
Advised a large medical device IVD manufacturer under an FDA Consent Decree how to effectively and successfully address process validation issues.
Performed various types of independent audits for pharmaceutical and medical device manufacturers in support of compliance with FDA regulations:
- internal quality system audits
- external supplier audits
- sponsor audits of clinical trial sites
Performed Regulatory Affairs activities for clients requiring:
-preparation and submission of premarkent approval and premarket notification dossiers to support FDA approval or clearance in advance of US marketing of medical devices.
- Prepared sections of Amended New Drug Applications describing manufacturing and testing facilities and activities
- Performed FDA-US Agent duties for ex-US medical device manufacturers.
Developed and implemented the following training programs for medical device manufacturers:
- Risk Management training for product assessment, essential user requirements and critical control point determination
- Design Control programs compliant with 21 CFR Part 820 and ISO 13485
- How to achieve ISO 9000 / ISO 13485 registration
|Year: 1977||Degree: MS||Subject: Microbiology / Immunology||Institution: Indiana University|
|Year: 1974||Degree: BA||Subject: Biology||Institution: University of Massachusetts|
|Years: 2000 to Present||Employer: Undisclosed||Title: Principal Consultant||Department:|
|Years: 1997 to 2000||Employer: Tripath Imaging||Title: Director, QA/RA||Department: QA/RA|
Responsibilities:• Prepared FDA Pre-Market Approval Applications for cervical cytology devices
• Developed clinical trial protocols and evaluated trial site compliance to GCP and approved protocols
• Successfully negotiated PMA and GMP issues with various FDA offices (ODE-CDRH and Atlanta District)
• Developed Design Control and Quality Systems compliant with FDA regulations and company preferences
• Led growth of R&D Validation Group and development of Validation Master Plan for Software and Hardware
• Directed ISO 9000 registration and CE Mark certification efforts
|Years: 1995 to 1997||Employer: Cardiovascular Diagnostics, Inc.||Title: Director, QA/RA||Department: QA/RA|
Responsibilities:Directed efforts of IVD Medical Device manufacturer (coagulation systems) comply with ISO 9000 standards; GMP / QSR; Medical Device Reporting regulations; Sterilization Equipment and Software Validations; Premarket Notification 510(k) Requirements; European Medical Device Directives.
• Extensive FDA interactions regarding 510(k)s; recalls, inspectional issues and medical device reports
• Administered QA and compliance programs including product testing, process / lyophilization validation, batch record review and supplier certification; FDA audit awareness and lead; international registrations; GMP train-ing; and MedWatch response.
• Implemented and chaired Management Review Board responsible for improving quality of non-conforming ma-terials and products. Non-conformities reduced by 50% over 6 months.
• Developed Quality Assurance Program for materials, labels and products in compliance with GMP and ISO.
• Directed company-wide program which successfully achieved ISO 9002 certification in 9 months.
|Years: 1981 to 1995||Employer: Bayer Corporation||Title: Manager, Biology / Biochemistry QA||Department: Biology / Biochemistry QA|
Responsibilities:Managed 45 employees (exempt and non-exempt) providing various biological testing: animal; cell-culture; microbial; ELISA; coagulation; enzyme; sterility; other immunoassay.
• Responsible for product testing (biochemical / biological potency, sterility) environmental monitoring (water systems, air systems, other utilities), facilities qualification and process validation (lyophilization, sterilization and aseptic filling).
• Developed sterilization validation protocols for steam, vapor phase hydrogen peroxide, dry-heat, ETO and ster-ile filtration processes;
• Developed cleaning validation protocols for stainless steel plasma mixing vessels (100 to 10,000 liters) using to-tal organic carbon analyzer and microbial monitoring methodologies.
• Coordinated FDA Establishment License Amendment allowing testing to begin off-site.
• Managed transfer of animal testing 1000 miles off-site with no loss in testing efficiency.
• Managed cross-functional project to validate construction of new animal facility and labs that completed activi-ties on-time.
|Years||Country / Region||Summary|
|Years: 1989 to Present||Country / Region: Japan||Summary: Advised medical device manufacturers on US FDA requirements and helped them develop successful premarket dossiers allowing product marketing in the US.|
|Associations / Societies|
|ASQ, Regulatory Affairs Professionals Society, ISPE, American Society for Microbiology|
|Licenses / Certifications|
|ASQ Certified Quality Engineer 1982
ASQ Certified Quality Auditor 1997
|Awards / Recognition|
|Marquis' Who's Who on the Frontier of Science and Technology 1984|
|Training / Seminars|
|Expert achieved ASQ certification as Quality Engineer and Quality Auditor|