Laboratory Inspection and Auditing

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 ins... Read more

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 Appreciate the regulatory requirements for reference and retention samples 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