Expertise

• Good Manufacturing Practices, GMP
• Regulatory Affairs Canada, submission preparation, pre-approval inspections
• Change control, complaint management, deviation and out-of-specification investigations
• Qualification and validation: process, cleaning, methods, filters
• Water for pharmaceutical purposes
• Bioanalysis
• Adverse event management
• Sterile product manufacturing, environmental monitoring
• FDA, QA, QC, quality assurance, quality control, audits
• Biologics, medical devices, warning letters

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.

Director of Regulatory Affairs, Eldan Pharmaceuticals, 1990-1994

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

Section Head, Health Canada, 1990

• Review of the chemistry and manufacturing aspects of drug submissions.

Director of Quality Assurance & Regulatory Affairs, 1982-1989

Member of the Executive Committee, Allergan Inc (now division of GlaxoSmithKline)

• Responsible for quality assurance, regulatory affairs, chemistry & 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), resulting in the Sterile Products chapter. 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
• Manager of Quality Control: Quality assurance, chemistry & microbiology laboratories, and graphics/labeling. 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

Quality Control & Technical Manager, Chemical Division, Pfizer, 1979-1981

• In a bulk compendial chemical plant, responsible for process troubleshooting and chemistry laboratory testing raw materials, in-process, and finished products.
• Chemist, Pharmaceutical Division, 1974-1979: Research new test methods, clinical sample testing, stability, finished product and raw material testing. Performed R&D experiments resulting in Pfizer Canada's first published research (Hypertension 4: 93, 1982) low-dose, clinical, pharmacokinetic study of a new anti-hypertensive agent, prazosin HCl. Designed, equipped, and started up a new R&D/microbiology/stability laboratory that was rated as the best laboratory in Pfizer manufacturing plants world-wide.

Honors & Publications

Professional Memberships

• The Organization of Professionals in Regulatory Affairs (TOPRA), Europe
• Parenteral Drug Association, USA
• Calibration & Validation Group (CVG)
• International Society for Pharmaceutical Engineering (ISPE), USA
• Canadian Association of Professionals in Regulatory Affairs (CAPRA)
• Pharmaceutical Sciences Group (PSG), Canada

Education

• B. S., Chemistry, University of Ottawa, Governor General's Study Group
• MBA studies, McGill University (one year)
• Certificate - Pharmaceutical Sciences Group - 50 hours of continuing education pertaining to the pharmaceutical industry