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Laboratory Inspection and Auditing

Event Details

Laboratory Inspection and Auditing

Time: March 16, 2022 from 10am to 5pm
Location: online
Street: Compliance Online
City/Town: Palo Alto
Website or Map: https://www.complianceonline.…
Phone: 8887172436
Event Type: webinar
Organized By: Complianceonline
Latest Activity: Jan 24, 2022

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Event Description

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

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

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