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How FDA Trains its Inspectors to Review CAPA, and Best Practices for Inspection Preparation - Webinar

  • ID: 4899863
  • Webinar
  • January 2018
  • Region: Global
  • 90 Minutes
  • Compliance Online
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Why Should You Attend:

Analytical instruments should be qualified to demonstrate suitability for the intended use. Companies are unsure on what exactly to qualify or re-qualify, test and document. The main reason is that unlike for analytical methods there was no clear standard with details for equipment qualification. This has changed. The USP has developed a chapter that provides a framework for analytical instrument qualification (AIQ).

This USP < 1058> webinar will give a good understanding of current and future FDA requirements and the USP framework. It also will provide detailed steps, examples and tools for cost-effective implementation.

Areas Covered in the Webinar:

FDA and EU requirements for analytical instrument qualification.
Most common inspection problems.
Terminology, scope and principles of the new USP chapter.
AIQ and its relation to method validation, system suitability testing and quality control checks.
Essential steps for AIQ: DQ, IQ, OQ, PQ
Purpose and contents of equipment qualification phases: design qualification, installation qualification, operational qualification, performance qualification.
Recommendations for firmware and software validation.
Roles and responsibilities: QA, manufacturer, user.
Approach for automated systems (incl. firmware/computer systems).
Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade).
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Jeff Kasoff, RAC, is the director of quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Mr. Kasoff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For 13 years prior to that, he served as director of regulatory affairs at Life-Tech, Inc., in which capacity he was similarly responsible for quality system oversight. Mr. Kasoff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. He received his Regulatory Affairs Certification in 1996.
Note: Product cover images may vary from those shown