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Stability Operations: A Comprehensive Review of Medical Product Stability Functions

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Overview / Abstract:

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 as well as for the stakeholders who support or rely on some aspect of the stability process.

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
• Regulatory Affairs Personnel
• Calibration and Validation Specialists
• Facilities/HVAC Staff
• Pharmaceutical Consultants

Course Description
This course focuses on the Operations (excludes testing and data analysis) 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.


Sep 11, 2018


Education (Higher Ed)


Live / Seminar, Seminar



Credits / Hours

1.2 CEUs



Presenters / Authors / Faculty

John O’Neill, Stability Information Specialist, Nagano Science USA; 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 43 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 for Stability at both Gilead and Regeneron. Mr. O’Neill currently serves as Stability Information Specialist for Nagano Science USA. He is a past chair of the Stability Working Group of the International Pharmaceutical Federation and is 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 29 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 story teller; bringing practical information backed by real-life experiences.

Keywords / Search Terms

CfPA Stability Operations, Pharmaceutical, Biological, Medical Device, Stabilitarians, Sample Control, QC/QA, Calibration, Validation, Regulatory Affairs, HVAC, Facilities, SOPs, chamber maintenance, ICH, WHO, FDA, risk management, training, protocols, life cycle stability strategies, storage conditions, chamber maintenance, monitoring, trending data, sample management. Seminar CE CME

LIVE Activity Location Details

09-10-2018 - 09-11-2018

New Brunswick
United States of America

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