Course Description

Stability Operations for Drugs, Biologics and Medical Devices: Steps to a Successful Stability Function | A 12 Hour On Demand Course

Online On Demand

Course Offering 230419VT2794A
Course ID 2794

In-Person Course

Who Should Attend?
This course is designed to benefit professionals in the Pharmaceutical, Biological, and Medical Device Industries who execute Stability Operations for their company.

Stakeholders who support, rely or otherwise liaise with the stability function would additionally benefit from understanding the requirements and challenges of stability operations.

These include:
- Stabilitarians and Product Stability Managers
- Sample Control Specialists
- Analytical Chemists, Microbiologists
- QC/QA Professionals
- Manufacturing Liaisons
- Packaging Liaisons
- Research & Product Development Scientists and Managers
- Calibration and Validation Specialists
- Facilities/HVAC Staff
- Pharmaceutical Consultants
- Regulatory Affairs Personnel

Course Description
This 12-hour accredited course focuses on the operational aspects of the stability function as practiced by the pharmaceutical, biological and medical device industries.

Establishing and maintaining strong stability operations programs will be covered, including: SOPs, training, protocols, life cycle stability strategies, storage conditions, chamber maintenance, and monitoring, trending data and sample management.

Preparing for inspections and auditing of the stability function will also be covered. Considerable attention will be given to risk management as applied to all aspects of Stability Operations.

The impact of several stability guidances (ICH, WHO, and FDA, among others) on Stability Operations will be discussed. The course concludes with a workshop for hands-on experience in risk management and auditing of Stability Operations programs.

Course Director
John O’Neill, Editor,

John O’Neill 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 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. 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. Mr. O’Neill currently serves as the Editor of a stability information website-