Canadian Regulatory Affairs Quality Control Expert for Pharmaceuticals and Medical Devices

Technical Consultant #1258


Expertise

  • Pharmaceutical Good Manufacturing Practices (GMP) for Canada.
  • Regulatory Affairs Canada, submission preparation.
  • Change control and complaint management.
  • Pre-approval inspections.
  • Pharmaceutical Quality Systems, clinical trial supplies.
  • Qualification and validation: process, equipment, cleaning and test methods.
  • Water for pharmaceutical purposes.
  • Bioanalysis.
  • Adverse event management; deviation and out-of-specification investigations.
  • Sterile product manufacturing; environmental monitoring.
  • FDA, QA, QC, quality assurance, quality control.
  • Vendor audits, API, active pharmaceutical ingredients, BPC, bulk pharmaceutical.
  • Canada FDA training programs.

Experience

Independent Consultant, 1994 - Present

  • Pharmaceutical, biological, medical device, and natural health products consultancy with expertise in helping companies solve manufacturing, GMP, quality, or regulatory issues.

Eldan Pharmaceuticals, Director of Regulatory Affairs, 1990 - 1994

  • Responsible for the development, registration, and launch of a new line of sterile and innovative products. Reported to the President.
  • Helped build the department from zero to multi-million dollar annual sales by achieving a high level of government product approvals.
  • Directed third-party manufacturers and laboratories which performed the development and testing required for the registration of the products.
  • Key member of the team that in-licensed new products.

Health Canada, Section Head, 1990

  • Responsible for the management of a group responsible for the review of the chemistry and manufacturing aspects of drug submissions.
  • Initiated what has become the ICH, Common Technical Document, Module 2. Quality Overall Summary.

Allergan Inc., (then a SmithKline Beckman Company), 1982 - 1989

Director of Quality Assurance & Regulatory Affairs, 1986 - 1989

  • As Member of the Executive Committee; responsible for quality assurance, regulatory affairs, chemistry and microbiology laboratories, and graphics/labeling.
  • Served as the company's contact with federal and provincial governments. Chaired several industry committees that negotiated new regulations.
  • Succeeded in negotiating the good manufacturing practice guidelines (3rd edition) which added the Sterile Products chapter and edited the other chapters. For the benefit of the entire industry:
  • Negotiated a one-year reformulation period for the removal of certain preservatives, and obtained fast-track regulatory review of the reformulations.
  • Negotiated realistic medical device labeling requirements.
  • Developed staff that were then able to be promoted to more senior positions.
  • Planned and coordinated both the laboratory and manufacturing aspects of the validation program as part of a major plant renovation resulting in an on-time start-up.

Manager of Quality Control, 1982 - 1986

  • Responsible for quality assurance, chemistry and microbiology laboratories and graphics/labeling. A group of eighteen professionals reported through three supervisors.
  • Obtained regulatory clearance for and helped launch a new chemical entity in nine months less than the industry average for government approvals at that time.
  • Hosted all Canadian and foreign government inspections. Passed two FDA inspections without receiving a Form 483.

Supervisor of Quality Assurance, 1982

  • Responsible for the final release of raw materials, finished products, packaging, labeling materials, vendor audits, and in-process inspection.

PFIZER INC., 1994 - 1982

Chemical Division, Quality Control and Technical Manager, 1994 - 1982

  • In a bulk compendial chemical plant, responsible for process troubleshooting and the chemistry laboratory which tested raw materials, in-process and finished products.

Pharmaceutical Division, Chemist, 1974 - 1979

  • Research into new test methods, clinical sample testing, stability, finished product and raw material testing.
  • Performed research and development experiments resulting in Pfizer Canada's first published research (Hypertension) - a low-dose, clinical, pharmacokinetic study of a then-new anti-hypertensive agent, prazosin HCl.
  • Designed, equipped, and started up a new research and development/microbiology/stability laboratory. When completed, facility was rated as the best laboratory in Pfizer manufacturing plants world-wide (then 180 locales).

Honors & Publications

Credentials

  • Certificate - Pharmaceutical Sciences Group - 50 hours of continuing education pertaining to the pharmaceutical industry

Academic and Professional Affiliations

  • The Organization of Professionals in Regulatory Affairs (TOPRA), Europe
  • Calibration & Validation Group (CVG), Canada
  • International Society for Pharmaceutical Engineering (ISPE), USA
  • Canadian Association of Professionals in Regulatory Affairs (CAPRA)
  • Parenteral Drug Association (PDA), USA
  • Chartered Chemist, Association of the Chemical Profession of Ontario (ACPO)
  • Pharmaceutical Sciences Group (PSG), Canada
  • Canadian Society for Chemistry (CSC)
  • Chemical Institute of Canada (CIC)

Education

  • MBA Studies, McGill University, (Accelerated-one year)
  • B. S. Chemistry, University of Ottawa, Governor General's Study Group
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