Laboratory Inspection and Auditing
2021-09-23 10:00 - 17:00 (America/New_York) | online
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 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

Learning Objectives:

US and EU GMPs relating to quality control operations
Appropriate GMP controls at each step in the analytical process
Information provided by different analytical techniques
Pharmacopoeias – contents, structure and regulatory significance
Significance of ICH guidance
Quality requirements for reference standards and reagents
What are critical consumables and how should they be controlled?
Control of analytical methods over their lifecycle
Appropriate qualification of analytical instruments
Data integrity – current expectations

Who will Benefit:

GMP auditors
Quality assurance professionals
Laboratory managers
Quality management

For more information visit https://medtechiq.ning.com/events/laboratory-inspection-and-auditing
