Ron Tetzlaff, Ph.D.

Ron Tetzlaff, Ph.D.

Ron Tetzlaff, Ph.D.

Corporate Vice President

Ron has more than 50 years of experience performing FDA inspections, conducting GMP audits, and evaluating compliance with GMP requirements for quality systems. Ron assists senior management at worldwide companies to optimize their systems, processes, procedures, and controls to comply to GxP requirements. He specializes in GMP compliance and quality systems services for the FDA legal community and clients in the pharmaceutical, medical device and biologics industries. Services include development of quality systems; establishing strategies and project plans for remediation of compliance issues involving warning letters and consent decrees; serving as expert consultant for consent decrees; conducting GMP audits and data integrity audits of production and laboratory facilities; managing teams of auditors for large projects involving multinational sites; and developing and presenting training to management and staff on topics related to quality systems, such as, approaches for managing and auditing data integrity, fundamentals of GMP documentation, regulatory trends, deviation management and investigations, and auditing principles.

Work Experience

Prior to joining Parexel, Ron served 27 years with the FDA. Between 1978 and 1993, he held the position of the FDA’s National Expert on Parenteral Drugs and Sterilization specializing in GMP inspections and investigations on a worldwide basis. In 1993, he joined consulting firm Kemper-Masterson, Inc. (KMI) where he founded and led a consulting services group that specialized in GMPs and Quality Systems which was later acquired by Parexel. From 2000 to 2004 he served as President of KMI.

Education

Ron received his B.A. in Zoology from the University of Washington, Seattle and M.S. and Doctor of Philosophy degrees in Pharmaceutics from the University of Georgia, Athens.

Ron is a member of PDA and FDLI, and is active in industry programs on quality management and GMP compliance related issues, having made more than 300 presentations at various national/international industry symposia and FDA training programs. He has published more than two dozen articles and several chapters in textbooks.

We are always available for a conversation.

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