To certify or not to certify - Webinar Recording

To certify or not to certify - Webinar Recording

Costs

ECA-Member*: EUR 199,--
Regular Fee*: EUR 249,--

(All prices excl. VAT)

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

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 Details

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:

When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Training Course Documentation and Certificate:

The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.

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
Recording from 05.08.2020
Duration of the recording: about 1.5 h.

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