CAPA - An important Element of the Pharmaceutical Quality System


Duration: 90 Minutes  

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The objective of this webinar is to inform personnel in the pharmaceutical industry of the growing expectation that each organization have an effective CAPA system. and demonstrating the action effectively correct and/or prevent the deviation.
Jerry Lanese   Product Id : 501442
  Instructor : Jerry Lanese

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Overview:

In this webinar we will discuss CAPA (Corrective Actions and Preventive Actions) , what they are and why the FDA expects the industry to initiate the investigation of any deviation and the complete recommended corrective and preventive actions. We will also discuss the CAPA System, the procedure or family of procedures that manage corrective actions and preventive actions from the observation of a deviation through the verification of the corrective or preventive action.

Why should you Attend: Recent FDA Warning Letters and 483s have included observations the firm's CAPA program was inadequate. It is important the appropriate staff understand what CAPA is, what constitutes a CAPA program, and what should be included in the program. The objective of this webinar is to inform personnel in the pharmaceutical industry of the growing expectation that each organization have an effective CAPA system that defines process and responsibilities for the identification, recording and investigation of deviations, the recommendation and execution of corrective actions and demonstrating that the action effectively correct and/or prevent the deviation.

Who Will Benefit:

  • Laboratory Managers
  • Laboratory Supervisors
  • Laboratory Analysts
  • Quality Assurance Managers
  • Quality Assurance Record Reviewers


Speaker Profile
John (Jerry) Lanese is an independent consultant with a focus on Laboratory Controls, Quality Systems and the components of an effective Quality System as they apply to the pharmaceutical and medical device industries and their suppliers to those industries. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan. Dr. Lanese focuses on the development of Quality Systems and trains extensively on related topics. He lectures throughout the world and presents training in all formats (lectures, seminars and webinars) on a variety of topics related to Quality Systems, GMPs, APIs, training, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar and conference providers. Jerry is a member of the Editorial Board of the Journal of GXP Compliance and co-edits a continuing column, “GXP Talk” in the Journal of GXP Compliance.




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