One-Day Online Lab Inspection and Audit Training –


DUBLIN–(BUSINESS WIRE)–Training “Laboratory inspection and audit” has been added to from offer.

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:

  • GMP auditors

  • Quality Assurance Professionals

  • Laboratory managers

  • Quality management

For more information on this training visit


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