David E. Jones

David E. Jones is an independent consultant who provides services primarily to the pharmaceutical industry. David started his industry career as a practicing pharmacist so the end product, i.e., the safe and efficacious medication dispensed to the patient, has always been his focus of what cGMPs are ultimately aimed to accomplish. He left the practice of pharmacy to earn a MS in business degree while starting a career with the A. H. Robins Company. His lessons in medical device efficacy were learned as Robins marketed the Dalkon Shield, an intrauterine contraceptive device. The product resulted in harm to patients and product liability suits led to the company’s demise. The issues surrounding the product played a role in the writing and promulgation of the Safe Medical Device Act of 1990. David continued to work for American Home Products (AHP), the successor to Robins, as a division vice-president for several years as AHP divested various business units to focus exclusively on finished drug products. Those divestitures eventually included the business units for which he was responsible prompting a change in career. Starting with the GMP Institute, then a privately held training group that was subsequently acquired by ISPE, David shared both his knowledge and his conviction that appropriate training was one of the important keys to successful CGMP implementation in firms. His former experience as a Toastmaster and his involvement in operations and corporate management equipped him to address operators and technicians and—very importantly—corporate offices on the value of CGMPs as a model for success in the making and distribution of finished drug products. He was chosen to provide background training to FDA field personnel on a quality system approach to auditing that was consistent with the adoption of the QRS (Quality System Regulation for medical devices and then later the QSIT (quality system investigation technique) for drug products. More recently, and as needs have dictated, he has worked with several of the large consulting groups as a team member or team leader to assist firms with remediation in response to warning letters or consent decrees. He has written and reviewed numerous articles for the Journal, many focusing on various aspects of training and facets other CGMP controls. David is a member of the Institute of Validation Technology Editorial Advisory Board.

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