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Medical Device and Pharmaceuticals Quality Management Expert Witness

Technical Consultant #478


Expertise

  • 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.

Experience

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

Positions held

  • Director of Clinical Quality Assurance
  • Director of Clinical Research
  • Senior Clinical Research Associate

Responsibilities

  • 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

Positions held

  • Compliance Coordinator, Research and Development
  • Senior Research Chemist

Responsibilities

  • 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


Credentials

Certifications

  • 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

Education

Ph.D. Pharmaceutics, Temple University, Philadelphia, PA

M.A. Organic Chemistry, Temple University, Philadelphia, PA

B.S. Chemistry, Albright College, Reading, PA

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