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About the Webinar
Many of us view the hard-won regulatory approval of our product as reaching a well-deserved finish line, but for those responsible for stability studies, it is actually arriving at a second starting line, with as many, if not more laps around the stability track ahead. This presentation will explore the stability steps required to arrive at Product regulatory approval as well as the numerous and diverse objectives to be achieved while conducting post-approval stability studies. These may include post-approval commitments, commercial product studies, shelf-life extensions, additions of suppliers, manufacturing sites, and dosage forms, and changes to test methods, packaging, and storage instructions, to name a few. Guidances, strategies and best practices will help us discover what we need to know in our quest to conduct efficient and effective stability studies.
About John O’Neill
John O’Neill earned his Bachelor’s degree in Pharmaceutical Sciences from Columbia University and a Master’s in Health Systems Management from Union University. His career of 47 years has taken him from Registered Pharmacist to-Liquids and Semi-solids Formulator at Sterling Winthrop-QC Manager at Sanofi-Aventis- Medical Device Quality Steward at Boston Scientific-Independent Consultant-Principal Stability Specialist for Biologics at Genentech-Associate Director for Stability at both Gilead and Regeneron.
He is a past chair of the Stability Working Group of the International Pharmaceutical Federation and was a member of the Product Quality Research Institute Stability Working Group for Shelf Life. Mr. O’Neill is a frequent conference speaker on stability topics. For the past 33 years he has been the Facilitator of the Pharmaceutical Stability Discussion Group, which has made him privy to just about everything that can go wrong or right with the Stability function. Mr. O’Neill currently serves as the Editor of a stability information website- StabilityHub.com