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COURSE ID 2801

Auditing Stability Programs: How to Ensure a Compliant Program

AVAILABLE On-demand
90 Minutes

On-Demand

Offering Price
$ 295
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Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

ACCREDITATION CEU's - 0.2 IACET RAPS
View Course Outline

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.

who should
attend?

LEVEL
Introductory
INTERESTS
Biotechnology / Biopharmaceutical Clinical Medical Devices / Diagnostics Pharmaceutical Science & Technology

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:

-Stabilitarians

-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 instructor

John O'Neill
Editor, stabilityhub.com

John O'Neill’s Courses
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.

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