Annex 1 - Requirements for Personnel in the Context of the Contamination Control Strategy - Webinar Recording

Costs

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

(All prices excl. VAT)

Registration

* also payable by credit card

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

Speakers

Dr Bettina Rietz-Wolf, GMP Inspector for EMA and local Government, Germany

Background

Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment, resulting in thousands of comments. A revised version was published in February 2020 and is open for limited comment by selected stakeholders.

Target Group

The webinar is aimed at managers and employees from the pharmaceutical and biopharmaceutical industries, who want to get a compact and comprehensive overview of the current requirements in the new Annex 1 with focus on personnel.

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

This webinar will inform you about the current status of the revision with regard to the topic of personnel in conjunction with contamination control (CCS Contamination Control Strategy). The current draft emphasizes in many cases that the networking and coordination of the individual measures, from design of airlocks to personnel clothing and gowning to personnel training and up to appropriate monitoring, is crucial for success and they must result in a coherent and coordinated overall concept. Accordingly, this webinar covers the core requirements:

Requirements for personnel in the context of Contamination Control Strategy
Air locks for Personnel
Protective garments
Qualification and Disqualification
Gowning Qualification
Monitoring of personnel

Recording from 17 September 2020
Duration of the Recording: Appr. 1,5 h

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