Auditing Stability Programs: How to Ensure a Compliant Program

Duration: 90 Minutes
Course Instructor

John O'Neill

$ 295
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

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 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:
• Identify sources for Audit targets
• Execute mechanics of Risk Management and identify systems to be evaluated
• Master aspects of effective audit training
• Build an Audit Host Team
• Facilitate effective “Day of” Audit practices

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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 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


John O'Neill’s Courses


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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