Canadian Regulatory Affairs Quality Control Expert for Pharmaceuticals and Medical Devices

Technical Consultant #1258

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.

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).

Credentials

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

Academic and Professional Affiliations