Understanding Process Validation in Biotechnology Manufacturing

US FDA’s Draft 2008 Process Validation Guidelines provide an excellent framework for understanding Process Validation. They describe the principles and approaches that the FDA feels the industry should use in executing validation lifecycle activities for developing and producing biopharmaceuticals. This fundamental online course introduces and uses some new terms and concepts not found in the US FDA 2008 draft guidelines. Those planning to use the guidelines should read and understand them, including the final version when it is approved, for specific guidance. At the conclusion of this course, participants will be able to:

  • Understand how to manage the uncertainties inherent in biotechnology manufacturing.
  • Define and explain the framework for structuring the process validation effort.
  • Describe and identify tools used to support process validation.
Mark F. Witcher, PhD
Senior Consultant

Mark Witcher, Ph.D is a Senior Consultant for IPS - Integrated Project Services in Morrisville, NC. At IPS, Mark does feasibility and concept process designs and operational plan development for novel and advanced facility designs. Prior to joining IPS in 2011, he was a consultant in the biopharmaceutical industry for 15 years on operational issues related to: Process development, product development; strategic business development; clinical and commercial manufacturing planning; tech transfer; and facility design and construction. He teaches courses on process validation for ISPE. He was previously the Sr. Vice President, Manufacturing Operations for Covance Biotechnology Services (formerly Corning Bio, Inc.). At Covance, he was responsible for the design, construction, start-up, and operation of Covance's $50MM contract manufacturing facility. Prior to joining Covance in 1995, he was Vice President of Manufacturing for Amgen, Inc. Mark was with Amgen for nine years and also held positions as Engineering Manager, Plant Manager, and Director of EPOGEN® Manufacturing. Mark received his Ph.D. in Chemical Engineering from the University of Massachusetts.

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