Due to changing regulatory requirements pharmaceutical Quality Control Compliance Managers are continuously facing new challenges. There are many regulatory requirements relevant for the pharmaceutical quality control, both in EU and in the US, for instance:
EU GMP Guide (Part 1 / Part 2 / Annexes)
21 CFR Part 210/211 (USA)
Guidances (EMA and FDA)
WHO and PIC/S Recommendations
Pharmacopoeias (Ph.Eur., USP)
QC Compliance Managers must be familiar with all these GMP-related topics and must be aware of the latest updates and the current interpretation of all these guidance documents.
In addition, analytical QC laboratories are increasingly in the focus of GMP inspections, both in Europe and in the US. For instance after FDA inspections, many laboratory-specific citations can be found in 483s and Warning Letters. And many findings related to the laboratory can also be found after inspections of European GMP supervisory authorities. Key compliance requirements include:
Change control systems
Calibration and qualification of analytical instrument
GMP compliant documentation
Validation of analytical methods
Validation of computerised systems
Procedures for handling OOS results
All these key compliance issues will be addressed in this course and the main topics also deepened in workshops.