Senior FDA Medical Device and Pharmaceutical Regulatory Consultant

Expertise

• Medical device submissions, regulatory affairs related to medical devices and pharmaceutical, good manufacturing practices (GMP) and Quality Systems Regulation (QSR).
• FDA compliance procedures including process validation, product validation, software validation, warning letters, consent decree resolution, compliance audits, supplier audits and ISO registrations.
• Extensive and broad knowledge of U.S. FDA quality and regulatory body regulations.
• Specializing in medical device submissions, regulatory affairs, and Good Manufacturing Practices (GMP).
• Quality Systems Regulation (QSR) compliance, process validation product and software validation.
• Warning letter and consent decree resolution, compliance audits, supplier audits and ISO registrations.
• Experienced in start-ups and re-engineering medical device quality systems.
• Experienced with blood bank operations, blood collection devices and FDA regulations.
• Medical software and information systems, experience including GxP geospatial analysis software, process control systems and software products regulated by the FDA.
• Expertise in all phases of the software development life-cycle, design controls, hazard analysis, validation, installation, support and PMA, 510(k), pre-IDE and de novo submissions.

Experience

Undisclosed Company, President and Owner, 2000 - Present

Undisclosed Company, Regulatory Affairs Consultant, 2000 - Present

• Acting Director of QA/RA and management representative for pre-production designer of non-invasive glucose measurement instrumentation.
• Prepared PMA submission, ISO and MDD/CE requirements for glucose measurement device, re-engineered quality system. Headed human factors engineering and design risk management. Assisted in assessment, evaluation and selection of contract designer and manufacturer.
• Prepared pre-IDE, 510(k) and de novo submissions, re-engineered quality system, managed efforts to correct warning letter deficiencies, ongoing audits and other projects.
• Prepared 510(k) submissions for patient wellness system and implemented QSR processes. Assisted in assessment, evaluation and selection of contract manufacturer (electronic).
• Implemented process, equipment and software validations for start-up fully automated filter manufacturing facility.
• Conducted full QSR audit and implemented corrective actions. Trained all employees on QSR and procedures. Prepared two 510(k) submissions.
• Assisted in assessment, evaluation and selection of contract manufacturer (Maquiladora).
• Developed and executed assessments, SOPs, validation plans, protocols and reports for an environmental monitoring information system including 21CFR11 requirements.
• Performed annual product evaluations, including evaluations of manufacturing and laboratory investigation reports. Conducted equipment/process equivalency studies.
• Performed various manufacturing equipment qualifications and validations.
• Developed SOPs, MVPs, protocols and executing validations for information systems and computer controlled automated equipment, systems, utilities and processes for biologic and blood diagnostic products, including validation requirements 21CFR11.
• Developed operating SOPs, developed and execute validation protocols for PLC controlled automated equipment and processes, for building/equipment cleaning and sanitation of OTC pharmaceuticals.
• Software, information system, process, equipment and electronic data/signature validations, including IQ, OQ and PQ, for diagnostic products.
• Conducted regulatory strategy and due diligence for the possible acquisition of various types of medical technology, including combination products.
• 510(k) gap analysis and final review of blood bank donor information system 510(k).
• Prepared a 510(k) submission for a power assisted hospital stretcher.
• Prepared a 510(k) submission for the addition of RF wireless technology to a blood bank donor information system.

Mediware Information Systems, Director, Regulatory Affairs and Quality Assurance, 1999 - 2000

• Directed the quality, regulatory, product validation, and product safety initiatives for a developer of blood bank, pharmacy and operating room information systems.
• Implemented automated software testing significantly reducing cycle time and providing a new product and service for sale to clients.
• Harmonized the quality systems of three 'merged' product centers.

Wyndgate Technologies Division, El Dorado Hills, CA, Director Quality Assurance and Regulatory Affairs, 1998 - 1999

• Directed the quality, regulatory and product safety initiatives for a developer of blood bank information systems.
• Re-engineered entire quality management and product safety/liability mechanisms. Coordinated ongoing 510(k) submissions and all FDA interactions.
• Preparation for ISO 9001 certification and 21CFR11 compliance.

Motorola Emtek Healthcare Division, Tempe, AZ, Assistant Vice President Quality Assurance and Regulatory Affairs, 1993 - 1998

• Directed the design and implementation of the quality, regulatory, product safety and client satisfaction initiatives for a developer of clinical information systems.
• Programs included the SEI CMM, Six Sigma quality, process mapping cycle time reduction, and Motorola Quality System Review, which has been ISO 9001 certified.
• Worldwide client base including in Europe, Japan and Australia. Member Motorola Corporate Product Safety Council.

Sunquest Information Systems, Tucson, AZ, Quality Assurance and Regulatory Affairs, 1991 - 1993

• Directed the implementation of the quality, regulatory, and product safety initiatives for a developer of blood bank and laboratory information systems.
• Proactive product safety and GMP initiatives led to much less FDA compliance action than any competitors saw in newly regulated industry.

White Knight Health Care, Asheville, NC, Director, Quality Assurance and Regulatory Affairs 1988 - 1991

• Re-engineered entire quality management system for manufacturer of sterile disposables.
• Re-instituted management's commitment to quality and safety.
• Managed approximately twenty 510(k) submissions. Managed 45 individuals including people in Maquiladora.

Johnson & Johnson, Sterile Design Division, Clearwater, FL, 1981 - 1988

Vice President Quality Assurance and Regulatory Affairs

• Directed quality, regulatory, safety, sterilization and laboratory functions for custom sterile procedure pack manufacturer.
• Pioneered implementation of 1978 FDA Medical Device Amendments. In 12 inspections at three facilities, company received no FDA Form 483 during this time frame.
• Managed major sterilization upgrade project, approximately fifteen 510(k) submission and department of 75 individuals.

General Manager

• Overall responsibility for manufacturing division, including sterilization and distribution.

Zenith Electronics, Chicago, IL and McAllen, TX, 1976 - 1981

• Purchasing positions beginning as Expeditor and ending as Manager.

Honors & Publications

Credentials

• FDA Special Commissioner's Citation
• Leadership Award - Center for Software Excellence
• AAMI Certificate of Achievement - GMP Requirements and Industry Practice
• AAMI Certificate of Achievement - Design Control Requirements and Industry Practice

Academic and Professional Affiliations

• Regulatory Affairs Professionals Society (RAPS)
• American Society for Quality (ASQ)
• Association for the Advancement of Medical Instrumentation (AAMI)
• Association of Blood Banks (AABB)

Education

• B.A. Economics, Northwestern University, Evanston, IL