Complying with FDA/ICH Requirements for Stability Testing
Course Description
Stability failures are consistently ranked as one of the top reasons for drug product recalls. Stability deficiencies also are cited regularly in 483s and Warning Letters, and sometimes even delay approval of new drug candidates. This course provides participants with the skills and knowledge to avoid such problems. How to streamline processes and save resources is another main focus of the course. Topics include comprehensive coverage of ICH guidelines; OOS investigations; bracketing and matrixing; documentation; CMC submissions; method validation; SOPs; and more. The material is presented in dynamic, engaging fashion, with numerous hands-on exercises to help participants apply key concepts to real-life scenarios encountered on the job.