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 accredited online training will cover all aspects of preparing for and conducting/hosting an audit of the medical product stability function.
Upon completion of this course, you will be able to:
FROM THE ATTENDEES:
“The course was great in supplying potential auditing risks found in stability programs. It allows my team to compare the industry expectations to what our company site is currently implementing and what we can improve in. John exhibited extensive stability auditing knowledge.” – Compliance Department at Zoetis
COURSE OUTLINE
Module 1:
Module 2:
Module 3:
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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/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.
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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