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Develop a Process Validation Roadmap: Case Studies Show How to Satisfy FDA’s Scrutiny
If you haven’t started revalidating your processes and using your change control SOPs, you’re headed for 483s and recalls that could cost millions of dollars.
Most drug and biologics manufacturers aren’t really sure how to comply with the FDA’s process validation (PV) guidance. Many don’t even want to apply the guidance to avoid having to revalidate their processes.
BONUS: Receive a customizable template document that will help you answer the FDA’s basic PV questions: How’d you get there? Can you prove your results in a repeatable manner? Show me what you’re doing going forward. This document has been used by drug and biologics companies, reviewed by FDA investigators and found acceptable.
The FDA has significantly changed its approach to process validation. You risk costly enforcement if you haven’t aligned your change controls, monitoring and trending efforts. Now, this 90-minute webinar helps you do it all with an easy-to-follow roadmap that has already helped companies with complex processes achieve compliance.
Process validation expert Rich Yeaton and Kelly Thomas shares their road-tested “roadmap” — a template that will enable you to use your existing PV data to satisfy regulators. Plus, they’ll share case studies of how three companies like yours have used the roadmap successfully.
Order the webinar CD and transcript to get the know-how you need to map out your own fastest, surest route to PV compliance, including how to:
This webinar CD and transcript offers hands-on guidance of value to executives and personnel in drug, biologics, API and combination product operating companies, including:
Meet Your Instructors
Rich Yeaton, president of East Coast Validation Services, LLC, has more than twenty years of experience working in FDA-regulated industries. He was initially introduced to GMP operations on the devices side as a development engineer in DuPont’s Medical Products Division. There, he developed and improved new process equipment and was told to validate what he had designed. He moved on to help start Phoenix Imperative, an engineering and validation consulting company serving the biopharmaceutical industry. A key achievement with Phoenix was leading validation teams at two MedImmune cell culture facilities to assist MedImmune to obtain its first two commercial licenses. He has since worked with small start-up companies and larger operating companies such as Merck, Genzyme, Wyeth and Lonza. He has in-depth experience with facility shutdowns and start-ups. Rich recently helped Avecia Biologics, a microbial fermentation contract manufacturer, to successfully prepare for its first preapproval inspection held in January 2009. He is a member of the ASME, the ISPE and the PDA and has degrees in electrical engineering and mechanical engineering from Lehigh University.
Kelly Thomas is Vice President of Quality at Atlantic Technical & Validation Services. Ms. Thomas has 18 years of experience in the pharmaceutical, biotech, and medical device industries. Her area of expertise is in developing, implementing and managing all quality assurance and quality control activities affecting cGMP operations. This includes development and implementation of Quality Systems that ensure compliance strategies are consistent with the corporate strategic mission, customer expectations and regulatory requirements. Ms. Thomas holds a Bachelor of Science in Biology from East Carolina University and a Master's of Business Administration from Meredith College. She also maintains several professional certifications from the American Society for Quality (ASQ).
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