Achieving and Maintaining Laboratory cGMP Compliance
Course Description
Laboratory controls is one of the six subsystems targeted by FDA inspectors during cGMP inspections. If your Laboratory Controls system is deemed "out of control," you may be subject to FDA enforcement actions and/or more frequent and stringent inspections. Therefore, ensuring laboratory cGMP compliance is vital. This two-day training course provides laboratory professionals with the skills and knowledge necessary to maintain and/or improve laboratory cGMP compliance. Topics include OOS investigations; good documentation practices; computer system validation; stability testing; method validation; HPLC; how to prepare for FDA inspection and more. After completion of this interactive training event, participants will return to their job with an in-depth understanding of laboratory cGMP requirements and how to implement industry best practices!