Quality control and related contract laboratories are considered at high risk because after testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check. That's the reason why the FDA and other agencies put highest emphasis on inspections of QC laboratories. Even though cGMP regulations have been in place for a long time, the large number of QC related 483's and warning letters demonstrate that companies have problems with implementation.
This two-day interactive in-person seminar will provide participants the regulatory background and guidelines through all critical areas of GMP compliance. This course helps attendees understand the latest requirements and also provides them templates and examples to develop inspection ready documentation.