Stability Testing – 2 CFR 211.166 (a & b)

Part of the GMP Laboratory Control Professional Certification Program

Duration: 90 Minutes
Course Instructor

David E. Wiggins

$ 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

In 2006, FDA withdrew both their approved 1987 Stability Guideline and their draft 1998 Stability Guidance and referred industry to the ICH Stability Guidances. In the absence of the detailed FDA guidelines, industry was left to interpret the somewhat ambiguous GMPs. The fact that stability issues continue to be a major cause for regulatory action and product recalls, it is apparent that not all companies are effective in understanding the requirements.

This accredited training course will provide a better understanding of how the pre-market stability programs can be successfully managed while minimizing the overall timeline, a key factor to the timely launch of new products. In addition, those requirements related to a compliant post-market stability program will be addressed.

Upon completion of this course, you will be able to:

  • Cite the Stability Regulatory Requirements
  • Enumerate the Seven GMP Stability Requirements
  • Describe the Relevant Stability Guidelines
  • Summarize Appropriate Stability Protocol and Report Content

This training is one part of the 10-course series required for the GMP Laboratory Control Professional Certification Program. Attend this course as part of the certification process or as a stand-along course for personal career advancement and training.

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This course is intended for individuals who have the responsibility for establishing the stability of drug products. This course will benefit individuals in:

  • R&D
  • Quality Control
  • Quality Assurance
  • Technical Operations
  • Contract Laboratories

Course Instructor


David E. Wiggins

Analytical/Stability Consultant

David E. Wiggins’s Courses
Team Training

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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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