Laboratory Inspection and Auditing
: 23 Oct 2020
Sector: Laboratory Equipment, Pharmaceutical
Quality auditing of pharmaceutical quality control laboratories is an important activity for those performing due diligence or monitoring the performance of a sub-contractor. Besides covering GMP regulations affecting pharmaceutical quality control, this one-day course is designed to provide the non-specialist with the necessary knowledge to understand the quality significance and risk associated with different analytical operations.
By the end of the course, attendees will be able to:Identify non-conformance to cGMP regulations in analytical operationsUnderstand the key steps in the analytical processRecognize commonly-used analytical techniques and instrumentsAppreciate the significance of pharmacopoeias in analytical operationsUnderstand the requirements for controlling reference standards, reagents and important consumablesAppreciate 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 classUnderstand current expectations for data integrity controls, including electronic data systemsIdentify non-conformances in the control of stability studiesAppreciate the regulatory requirements for reference and retention samples