Be Ready to Meet the Rigor of Laboratory Inspections
Good Laboratory Practices and the related Quality Assurance and Quality Control measures are a critical piece to any pharmaceutical ecosystem. The US FDA has provided a solid framework within 21 CFR 58, GLP for Nonclinical Laboratory Studies which can be used for the quality portions of any type of pharmaceutical based laboratory.
However, as you search FDA Warning Letters for laboratory issues, there are still so many challenges both in the analytical and microbiological arenas ranging from personnel training, failure to adhere to procedures, test method and transfer errors, handling of OOS (out of specifications) and contract laboratory oversight issues, to name a few.
In this webinar, we will break out the important requirements needed to assure compliance and to help you verify that the practices in place will meet the rigor of inspection readiness and accurate test reporting.
Join us to discuss regulations on:
- Organization and Personnel Requirements
- Quality Assurance (Controlled Documents and Analytical Review and Release Processes)
- Laboratory Equipment (Design, Qualification, Calibration, Maintenance and Periodic Reviews)
- Reagents and Standards Management Practices
- Test Method Development, Validation [ICH Q2 R1] and Transfer (Compendial versus In-house)
- Sample Handling
- Electronic (LIMS) versus Paper Records Management including Data Integrity Requirements
- Handling of Out of Specification Results
- Qualification and Use of Contract Laboratories
