This 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 guidance’s (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.
Upon completion of this course, you will be able to:
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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:
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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