FDA Foreign and Domestic Drug Investigation Consultant

Technical Consultant #884


Expertise

  • Domestic and foreign pre-approval and CGMP Investigations.
  • Inspect and investigate activities of pharmaceutical manufactured drugs from an FDA point of view.
  • FDA drug foreign Investigations included pharmaceutical manufactures in Canada, Belgium, Israel, Australia, Japan, Italy and France.
  • Conducted independent international inspections to determine compliance with CGMPs of bulk drugs, new drugs.
  • Validation of analytical methods.
  • Laboratory FDA certification.

Experience

Independent Consultant, Present

Food and Drug Administration, Philadelphia, PA, 1974 - 1998

New Drug Application/Abbreviated New Drug Application (ANDA) Coordinator

  • Reviewed analytical methods validation for new drugs and generic drugs with direct interaction with various investigation branches within the FDA, the Center for New Drugs, and the Office of Generic Drugs.
  • Reviewed analytical methods validation and global pharmaceutical companies and their various manufacturing locations.
  • Coordinated with NDAs, ANDA reviewers and secondary FDA Laboratories to determine approval or disapproval status of the analytical method validation.
  • Maintained logs on each of the applications validated in the Philadelphia's Laboratory and provided information to the Science Branch.
  • Reviewed the analytical data obtained on each of the method validation and determined the recommendations for the approval or disapproval.
  • Prepared method validation endorsement for the Science Branch Director.

Research Coordinator and Analytical Chemist

  • Reviewed technically all research assignments, collaborative studies, NDA, ANDA and National Check Sample Program.
  • Monitored the U.S.P. official reference standards and working standards.
  • Reviewed scientific journals and updated the laboratory methods' file.
  • Had direct contact with office of Field Science and various bureaus.
  • Reviewed research proposals.

Analytical and Regulatory Chemist

  • Fulfilled the mandatory training program by FDA as required for new chemist.
  • Laboratory focus on drug and food analyses, micro and macro analyses.
  • Developed background in FDA laws, current good manufacturing practice and the various compliance programs.

Domestic and Foreign Pre-approval and CGMP Investigations

  • As a member of the investigative team conducted both domestic and foreign visits and participated in various pre-approved and CGMP investigations.
  • Foreign investigations included: Canada, Belgium, Israel, Australia, Japan, Italy and France.
  • Conducted independent international inspections to determine compliance with CGMPs of bulk drugs and new drugs.
  • Trained new international drug analysts for investigation.

Honors & Publications

Academic and Professional Affiliations

  • American Chemical Society
  • Delaware Valley Chromatography Forum
  • A.O.A.C. International

Credentials

  • Fluent Italian
  • Modern Analytical Methods, Illinois Institute of Technology, Chicago, II

Education

  • B.S. Chemistry, Italy, Institute Technical Industrial for Chemists, Chieti, Italy
  • B.S. Chemistry, Saint Joseph's University, Philadelphia, PA
  • M.S. Analytical Chemistry, Saint Joseph's University, Philadelphia, PA
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