One-Day Lab Inspection and Audit Online Training Course

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DUBLIN, July 11, 2022 /PRNewswire/ — “Laboratory Inspection and Audit” training has been added to from ResearchAndMarkets.com offer.

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The quality audit of pharmaceutical quality control laboratories is an important activity for those who carry out due diligence or monitor the performance of a subcontractor.

In addition to covering GMP regulations affecting pharmaceutical quality control, this one-day course is designed to provide the non-specialist with the knowledge necessary to understand the importance of quality and the risks associated with different analytical operations.

At the end of the course, participants will be able to:

  • Identify non-compliance with cGMP regulations in analytical operations

  • Understand the key stages of the analytical process

  • Recognize commonly used analytical techniques and instruments

  • Appreciate the importance of pharmacopoeias in analytical operations

  • Understand control requirements for important reference standards, reagents and consumables

  • Appreciate the importance of GMP controls on the relevance of analytical methods (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 control, including electronic data systems

  • Identify non-conformities in the control of stability studies

  • Appreciate regulatory requirements for reference and retention samples

Learning objectives:

  • American and European GMPs relating to quality control operations

  • Appropriate GMP controls at each step of the analytical process

  • Information provided by different analytical techniques

  • Pharmacopoeias – content, structure and regulatory significance

  • Importance of ICH guidelines

  • Quality requirements for reference standards and reagents

  • What are critical consumables and how should they be controlled?

  • Mastery of analytical methods over their life cycle

  • Appropriate qualification of analytical instruments

  • Data integrity – current expectations

  • Control of stability studies

  • Reference and Preservation Sample Requirements

Who should attend:

For more information on this training visit https://www.researchandmarkets.com/r/wumoap

Media Contact:

Research and Markets
Laura Woodsenior
[email protected]

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