Webinar: To certify or not to certify

Webinar: To certify or not to certify

Course No 18105

Important: Deadline is 12 noon on 22 July 2020

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Speakers

Sue Mann, Sue Mann Consultancy

Background

Annex 16 (Certification by a Qualified Person and Batch Release) of the EU GMP Guide describes the "handling of unexpected deviations". A batch with an unexpected deviation concerning the manufacturing process may be certified if the result of a risk analysis performed shows that "the potential impact of the deviation on quality, safety or efficacy of the batch(es) concerned and conclusion that the impact is negligible."
This flexibility might sound reasonable but puts a lot of responsibility on the QPs. There will always be borderline cases and ambiguities.

Target Group

This Webinar has been designed for EU Qualified Persons (QP) but also QA personnel, upper management functions and other interested people who want to be informed about QP challenges when certifying batches.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

  • Batch deviations and QP Certification: degrees of freedom and limits as defined in the guidance
  • Discuss based on real-life scenarios:
    • Potential risks and impact
    • Batch certification possible or not
    • Consequences and further actions

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