CAPA – An Element of the Pharmaceutical Quality System

Event Information
Product Format
Prerecorded Event
Presenter(s)
Conference Date
Thu, Jul 20, 2017
Length
90 minutes
Product Description

Understand the Importance of Corrective Actions and Preventive Actions (CAPA) in the Pharmaceutical Quality System

A proactive program of corrective actions and preventive actions (CAPA) is an important element of the pharmaceutical quality system. It provides the framework for the proactive program that identifies deviations from the required or the norm, and recommends and executes actions that will correct the current deviation and/or prevents the occurrence of a similar deviation in the future.

CAPA is an important part of any quality system. The expectation for CAPA began to appear in the FDA regulated environments with the release of the quality system regulation (21CFR820) in 1996. It has become more significant as the agency focuses more on the concept of continuous improvement. Many observations found in FDA 483 reports and warning letters cite deficiencies in the CAPA system. The expectation for an effective CAPA system is not unique to standards for FDA regulated industries. It is found in all quality systems.

Join this session by expert speaker Dr. Jerry Lanese, Ph.D., to discuss the growing expectation of every organization for an effective pharmaceutical system that has an element of CAPA. Dr. Lanese will provide understanding on an effective CAPA system that allows the identification, logging, investigation and determination of the cause of deviation, corrects the current deviation, and prevents future occurrence of deviation.

Session Highlights:

  • What are CAPA?
  • Why the FDA expects the industry to initiate and complete CAPA?
  • Procedures that manage CAPA from the observation of a deviation through the verification of the corrective or preventive action
  • Processes and responsibilities for the identification, recording and investigation of deviations
  • Recommendations and execution of corrective actions preventive actions (CAPA)
  • Demonstrating that the action effectively corrects and/or prevents the deviation

Who Should Attend?

Personnel in production, quality control, quality assurance, materials, and functions that support these, will benefit from an understanding an effective CAPA system—a system for identifying, logging, investigating, determining the cause of the deviation and correcting the current deviation and/or preventing future occurrences of the deviation.

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Dr. Jerry Lanese - Pharma Guidelines Expert

Dr. John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where...   More Info
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