Stability Testing - 21 CFR 211.166 (a & b)

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 (90 minute) 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.

THIS TRAINING IS PART OF OUR GMP LABORATORY CONTROL PROFESSIONAL CERTIFICATION

• To enroll into the complete GMP Laboratory Control Certification Program CLICK HERE.  This program includes 10 specific online courses for $2050.
• To learn more about our certification programs, visit our website at Certifications 

​To register for this individual course ONLY, click the Register Now button below.