2020 - Laboratory Inspection and Auditing

Identify non-conformance to cGMP regulations in analytical operations
Understand the key steps in the analytical process
Recognize commonly-used analytical techniques and instruments
Appreciate the significance of pharmacopoeias in analytical operations
Understand the requirements for controlling reference standards, reagents and important consumables
Appreciate the importance of GMP controls over analytical method suitability (validation, verification and transfer)
Classify analytical instruments according to quality risk and understand the qualification requirements for each class
Understand current expectations for data integrity controls, including electronic data systems
Identify non-conformances in the control of stability studies
Appreciate the regulatory requirements for reference and retention samples