Medical Device and Pharmaceuticals Quality Management Expert Witness
Technical Consultant #478
- Quality assurance, clinical research and regulatory affairs to assist in quality systems improvements, product development, and marketing approval of medical products.
- Quality management for medical devices, pharmaceuticals, and biologicals.
- GLP, cGMP, GCP, ISO-13485 and ISO-9000 regulations as they apply to quality systems audits to assure compliance with regulations and standards.
Expert Witness Experience
- Five cases, one court testimony.
- Assisted in the reversal of three Federal Court consent decrees.
Undisclosed Company, Independent Consultant, 2001 - Present
- International engagements include Croatia, Canada, Netherlands, and Taiwan.
- Assist medical device, pharmaceutical, and biological firms as well as contract laboratories to develop and improve their quality systems.
- Gained approval for a device manufacturer to resume production and sales following regulatory closure.
- Assisted a major pharmaceutical company identify problems in their clinical development program that resulted in approval of a multi-billion dollar product.
Regulatory Affairs and Clinical Research Consultant
- Servicing the Medical Products industry.
- Provided services for numerous pharmaceutical, device, cosmetic and medical product companies.
Flemington Pharmaceutical Corporation, Flemington, NJ, 1998 - 2001
Vice President of Product Development
- Responsible for Product Development and Quality Assurance, with emphasis on formulations which were designed to deliver rapid blood molecule absorption.
- This encompassed analytical methods development, contract manufacturing and testing, clinical trials for licensing and product submissions, resulting in one approved product.
Medical Development Quality Associates, Lenexa, KS, President, 1992 - 1998
- Successful execution in clinical research, quality assurance, regulatory affairs, ISO-9000 compliance to assist in development, marketing approval and maintenance of medical device products.
- Provide technical training in GCP, GLP, cGMP and ISO-9000.
- Conduct audits to assure compliance with regulations and standards.
- Major clients: Warner-Lambert Co., Hoechst-Marion-Roussel, Inc., Procter & Gamble, Battelle Laboratories, Novartis Pharmaceuticals, Sarnoff Research Institute, Government of Pakistan, and Centeon Pharmaceutical Products.
- Assisted in the reversal of three Federal Court consent decrees.
Oread Laboratories, Inc., Lawrence, KS, Manager of Regulatory Affairs, 1991 - 1992
- Managed quality assurance of laboratory services, including GLP and GMP compliance.
- Supervised the IND development, analytical testing, contract manufacturing, clinical trials and licensing of an approved drug for neonates.
- Developed client confidence, resulting in 30% growth in staff and new contracts.
Pharmaceutical Consultants, Inc., Leawood, KS, Director of Corporate Development, 1989 - 1990
- Directed all daily activities of clinical research and regulatory affairs staff of contract clinical research organization.
- This included numerous projects for domestic and international pharmaceutical and biological products clients.
- Additional responsibilities encompassed identification of new opportunities, bids for contract, budget negotiations and technical/regulatory consulting.
- Staff increased by over 200% in eighteen months.
Martec Pharmaceutical, Kansas City, MO, Director of Clinical Research, 1988 - 1989
- Directed all aspects of clinical development of ethical and generic drugs.
- Clinical development protocol design, investigator selection, budget preparation, data review, clinical reports, selection of contract research organizations, and supervision of study monitoring.
- Interacted with all other departments to assure integrity of products and quality of regulatory submissions.
- Clinical research therapies included cardiology, rheumatology, gastroenterology and psychiatry.
Seton Company, Malvern, PA, Director of Regulatory Affairs/Quality Assurance, 1984 - 1987
- Directed all regulatory and quality assurance activities for five company divisions including submissions to federal and state agencies.
- Oversaw pre-clinical and clinical trials for new medical devices.
- Supervised manufacturing of all biologically-based products.
- Monitored bio-products research to ensure validity of procedures and equipment.
- Prevented the loss of a major customer by developing analytical support, manufacturing capabilities, and credibility to produce acceptable components for wound dressings.
Janssen Pharmaceuticals, Inc., Piscataway, NJ, 1976 - 1984
- Director of Clinical Quality Assurance
- Director of Clinical Research
- Senior Clinical Research Associate
- Identified an invalidating flaw in an NDA, which prevented the rejection of the application.
- Directed the activities of four research groups working on domestic and international drug development. This encompassed 12 new chemical entities, seven of which have been approved in the U.S.
- Supervised a staff of 16 and controlled an annual budget exceeding $2 million.
- Clinical research activities included immunology, rheumatology, oncology, cardiology, mycology, anesthesiology, gastroenterology, and allergology.
Harleco, Division of American Hospital Supply Corp., NJ and PA, 1970 - 1976
- Compliance Coordinator, Research and Development
- Senior Research Chemist
- Managed all documentation for a line of 400 diagnostic products.
- Established expiration dates for all company products.
- Developed and patented an in vitro test reagent in various packaged forms.
- Adapted established reagents to meet defined packaging requirements for a new clinical chemistry analyzer.
- Initiated and managed new product clinical research testing program.
Educator: National and International
- Good Laboratory Practices for Pre-Clinical Testing, Berlin, German
- Course Director: Good Laboratory Practices for the Center for Professional innovation and Education, Inc., Malvern, PA
- Center for Professional Advancement, Course Director for Good Laboratory Practices, Instructor for Quality Management.
- Part-time Lecturer at Univ. of Missouri, College of Pharmacy.
- Part-time Lecturer at the Business and Industry Institute, Johnson County Community College, Overland Park, KS.
Honors & Publications
- Regulatory Affairs Professional Society Certification
- Certified ISO-9000 Lead Assessor(IRCA)
Continued Education and Training
- Design and Conduct of Stability Studies for Developing Product Expiration Dates
- Design and Conduct of Clinical Trials
- Preparation and Filing of IND's and NDA'S
- Processes and Documentation for Sterile Products
- FDA Requirements for Health Products Derived from Biotechnology
- Teleconference from the Juran Institute on Total Quality Management
- ISO-9000 Lead Assessor Course and Examination
- FDA/FDLI Video Teleconference-The 510k Process
- Numerous courses on Good Clinical Practices
Academic and Professional Affiliations
- American Society for Quality Control (General and Auditing Divisions)
- Regulatory Affairs Professional Society
- American Diabetes Association
- SynVax Pharmaceuticals, Inc, Board Member
Ph.D. Pharmaceutics, Temple University, Philadelphia, PA
M.A. Organic Chemistry, Temple University, Philadelphia, PA
B.S. Chemistry, Albright College, Reading, PA