About the webinar
The one-hour seminar will cover the recent evolution of the FDA's 2011 Process Validation (PV) guidelines to a more effective Lifecycle Process Development and Validation (LPDV) paradigm. The original PV approach, supported by ICH Q8 (R2) – Pharmaceutical Development and ICH Q9 – Quality Risk Management guidelines, has serious fundamental weaknesses. LPDV was developed to mitigate the limitations of PV by using a risk-based approach and extending process understanding tools to simultaneously develop and validate processes using a structured paradigm. The seminar will discuss how LPDV can be used to design and execute manufacturing process unit flows as well as the many other processes a manufacturing organization needs to successfully produce 21st century biopharmaceuticals, including advanced cell and gene therapies. A question and answer session will follow the seminar.

Mark F. Witcher, Ph.D.

Mark has over 35 years of operations, engineering and leadership experience in biopharmaceuticals. Most recently, he worked for several engineering firms on feasibility and concept studies for advanced biopharmaceutical manufacturing facilities. He has spent many years as a consultant on operations issues related to product and process development, strategic business development, clinical and commercial manufacturing, technology transfer and facility design. Previously, Mark was SVP of Manufacturing Operations for a CMO responsible for the design, construction, commissioning and operations of his $50 million contract manufacturing business. Prior to that, he was VP of Manufacturing at Amgen. Mark was with Amgen for nine years, holding positions as Engineering Manager, Plant Manager and Director of EPOGEN® Manufacturing. He received his PhD in Chemical Engineering from the University of Massachusetts in 1976. Reach him at [email protected] or on LinkedIn.

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