Course Description

Auditing Stability Programs: How to Ensure a Compliant Program

Online On Demand

Course Offering 2208903OL2801A
Course ID 2801

In-Person Course

Who Should Attend?
This online training is intended for professionals in the pharmaceutical, biopharmaceutical, medical devices, veterinary and cosmetic industries. It will be especially valuable to those working as:

•Quality Management, QA and QC Professionals
•Stability Stake Holders (Chambers, Labs, Facilities, etc.)

Personnel who manage these individuals would additionally benefit from this training by gaining a better understanding of the issues faced in ensuring a GMP-compliant stability program.

Course Description
A significant number of 483’s and Warning Letters related to the stability function is proof that not all companies have an adequate program in place. Since regulatory requirements and guidance’s provide only a general picture of expectations for stability programs, much interpretation is left up to individual companies. A better understanding of regulatory expectations and careful preparation is warranted to avoid joining those organizations receiving stability citations.

This 90-minute, accredited ON DEMAND online training will cover all aspects of preparing for and conducting/hosting an audit of the medical product stability function.

Course Director
John O’Neill, Stability Information Specialist/Editor Founder and Facilitator of the Pharmaceutical Stability Discussion Group

John O’Neill, Stability Information Specialist/Editor Founder and Facilitator of the Pharmaceutical Stability Discussion Group.

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 45 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, and Associate Director of 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. For the past 34 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 is a frequent conference speaker on stability topics and currently serves as Editor of

Past participants in Mr. O’Neill’s industry programs have reported that he is knowledgeable, engaging, and a great storyteller; bringing practical information backed by real-life experiences.