1 Day Laboratory Inspection and Auditing Online Training Course

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DUBLIN, July 11, 2022 /PRNewswire/ — The “Laboratory Inspection and Auditing” training has been added to ResearchAndMarkets.com’s offering.

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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
  • Control of stability studies
  • Requirements for reference and retention samples

Who Should Attend:

  • GMP auditors
  • Quality assurance professionals
  • Laboratory managers
  • Quality management

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

Media Contact:

Research and Markets
Laura Wood, Senior Manager
[email protected]

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SOURCE Research and Markets

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