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Laboratory Inspection and Auditing

Please Note : This is an old event click here to know more about organizer

: 23 Oct 2020

Sector: Laboratory Equipment, Pharmaceutical

Type: Seminar

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

Learning Objectives:

US and EU GMPs relating to quality control operationsAppropriate GMP controls at each step in the analytical processInformation provided by different analytical techniquesPharmacopoeias – contents, structure and regulatory significanceSignificance of ICH guidanceQuality requirements for reference standards and reagentsWhat are critical consumables and how should they be controlled?Control of analytical methods over their lifecycleAppropriate qualification of analytical instrumentsData integrity – current expectationsControl of stability studiesRequirements for reference and retention samples

Who will Benefit:

GMP auditorsQuality assurance professionalsLaboratory managersQuality management


Compliance Online
Phone: +1 650-620-3937
Email: referral@complianceonline.com

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