Biographies

Robert D. Tollefsen

Robert spent his first 10 years with FDA as a Drug Chemist where he was routinely called upon by FDA Districts and by FDA's Division of Field Investigations (DFI) as a specialist to inspect computerized systems in pharmaceutical testing laboratories and in pharmaceutical production operations located within FDA's Pacific Region and abroad on international FDA team inspections. He then worked 3 years as a Drug Investigator for FDA's Seattle District where he continued to regularly be requested as a specialist in auditing computerized systems of FDA regulated companies. He was then promoted to his current position in FDA's DFI as their National Expert Investigator specializing in computer systems where he has inspected drug and biologics firms across the U.S.A and throughout the world. Additionally, Robert is an instructor at numerous FDA national training courses for FDA Investigators and FDA Analysts to include; Basic Drug School, Pre-Approval Investigations, International Inspections, Computer System Validation, and Introduction to Inspections of Pharmaceutical Laboratories. Robert also has given presentations at academic and industry seminars across the U.S.A. His inspectional experience includes sterile drug manufacturers, solid oral dosage form manufacturers, vaccine manufacturers, device manufacturers, bulk drug manufacturers (biotech derived and traditional), contract testing laboratories, Clinical Investigators, Institutional Review Boards, Air Separation Unit (ASU) facilities, & GLP laboratories.

Professional Organizations & Activities:

• Active Steering Committee member for the International Society of Pharmaceutical Engineers-Good Automation Manufacturing Practices forum (ISPE-GAMP)
• Active Editorial Board member for the Drug Information Association's (DIA) Computerized Systems for Nonclinical Safety Assessment rewrite.
• Active Technology Advisory Board member for the Life Sciences Institute for Technology (LIST) Global Institute

Regulatory Reviewer for the following ISPE-GAMP Good Practice Guides:

• IT Infrastructure Control & Compliance
• A Risk-Based Approach to Compliant Electronic Records and Signatures
• Validation of Laboratory Computerized Systems

The U.S. Food & Drug Administration is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
www.fda.gov