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

Costs

ECA-Member:	EUR 199,--
Non ECA Member:	EUR 249,--

(All prices excl. VAT)

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 GroupThe 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.

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

Duration of the Recording: Appr. 1,5 h

Recording from 17 September 2020

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