John Y. Lee, Executive Director

Specialist in Pharmaceutical GMP Compliance Consultation


Professional Experience

Executive Director
Pharmaceutical Compliance Associates
Massapequa, New York
Henderson, Nevada

8/91 - Present

Director, Quality Assurance and Quality Control
Altana, Inc.
Melville, New York

3/88 - 8/91

Quality Assurance Manager
Organon, Inc.
West Orange, New Jersey

4/85 - 3/88

GMP Compliance Associate
Ortho Pharmaceutical Corporation
(Div. Johnson & Johnson)
Raritan, New Jersey

12/83 - 4/85

Consumer Safety Officer (Investigator)
U.S. Food & Drug Administration
East Orange, New Jersey

10/77 - 12/83

Pharmaceutical Technical Experience

  • Extensive GMP auditing and consultation experience in active pharmaceutical ingredients (API) and finished pharmaceuticals, with specialization in FDA pre-approval inspection (PAI) audits and sterile products (aseptic processing, terminal sterilization, lyophilization).
  • 100% success rate in assisting clients to secure approval at the initial FDA pre-approval inspection (PAI). PAI country clients include US, Europe (Germany, Italy, France, Denmark, Netherlands, Sweden, UK, Spain, Norway), China and Japan.
  • Active involvement in the design, renovation and validation of sterile and non-sterile pharmaceutical facilities.
  • Designed validation studies, prepared validation documents, and coordinated validation projects for sterile and non-sterile operations.
  • Developed and organized Quality Assurance operations and programs including batch record review, product annual review, documentation control, quality assurance investigation, auditing, GMP and technical training, validation, product stability, complaint investigations, etc.
  • Developed and presented training programs for line personnel, supervisors and management, and senior executive management (e.g., CEO and Vice Presidents) on topics of GMP compliance, validation, quality assurance programs, and sterilization science and technology.

Publications

  1. “Checklist for Computer Software Validation,” Pharmaceutical Technology, February 2014.
  2. “Change Management: Common Failures and a Checklist for Improvement,” Pharmaceutical Technology Europe, May 2010.
  3. “Product Annual/Quality Review: US/EU Comparative Analysis and Interpretations,” Phamaceutical Technology, 32(3): 88-104, March, 2008
  4. "Good Laboratory Practices (GLP) Regulations: Interpretation Techniques and Review of Selected Compliance Issues," Drug Information Journal, 40(1): 33-38, 2006
  5. “FDA Compliance Issues For Cleaning Validation,” STP Pharma Pratiques, 10(5): 292-295, September-October, 2000.
  6. "Documentation Requirements for Preapproval Inspections," Pharmaceutical Technology, 17(3):154-164, March, 1993.
  7. "Validation Organization and Documentation," Pharm Tech Japan, 9(2):151-161, February, 1993.
  8. "Recent Trends in Process Validation," chapter in Pharmaceutical Process Validation, Marcel Dekker, Inc., New York, 573-586, 1993.
  9. "Validation Terminology and Concepts," Pharm Tech Japan, 8(9):7-16, September, 1992.
  10. "Sterilization Control and Validation for Topical Ointments," Pharmaceutical Technology, 16(3):104-110, March, 1992.
  11. "Product Annual Review," Pharmaceutical Technology, 14(4):86-92, April, 1990.
  12. "Investigating Sterility Test Failures," Pharmaceutical Technology, 14(2):38-43, February, 1990.
  13. "Validating an Automated Filter Integrity Test Instrument," Pharmaceutical Technology, 13(10):48-56, October, 1989.
  14. "Security for Pharmaceutical Audit Reports," Pharmaceutical Production TechSource, 4(6):3, June 1989.
  15. "Auditing an Aseptic Filtration Process," Pharmaceutical Technology, 13(2):66-72, February, 1989.
  16. "Environmental Requirements for Clean Rooms," Bio-Pharm, 1(7):40-43, 1988 reprinted 2(2):42-45, February, 1989.
  17. "GMP Compliance for the Lyophilization of Parenterals: Part II," Pharmaceutical Technology, 12(11):38-42, November, 1988.
  18. "GMP Compliance for the Lyophilization of Parenterals: Part I," Pharmaceutical Technology, 12(10):54-60, October, 1988.
  19. "Essential Elements for Establishing and Performing an Internal GMP Audit," Pharmaceutical Manufacturing, 3(2):18-21, February, 1986.
  20. "GMP Compliance for Clinical Packaging," Pharmaceutical Manufacturing, 2(9):34-38, September, 1985.

Courses and Lectures

Course director, symposium chairman, moderator and trainer/speaker for professional organizations:

  • Parenteral Drug Association
  • Pharm-Tech Conference
  • PharmaNet, Inc.
  • Technomics
  • InfoScience
  • Key to Compliance (Sweden)
  • Blue Bell Consulting (China)
  • The Center for Professional Advancement
  • Medical Manufacturing TechSource
  • American Society for Microbiology
  • Institute for Applied Pharmaceutical Science
  • Technical Seminars
  • AP3 (France)
  • China Food & Drug Administration (China FDA Inspectors)

Professional Affiliations

Founder of the GMP Compliance Network; Former Vice President of the North Jersey Chapter of the International Society for Pharmaceutical Engineers (ISPE), Former Vice President of the GMP Education and Training Association, Member of the Parenteral Drug Association, Member of the ISPE.


Education

MBA - Pharmaceutical Studies, Fairleigh Dickinson University, Teaneck, New Jersey, 1991
BA - Biology, New York University, New York, New York, 1976