Annex 1 - Quality Risk Management using the example of the Contamiation Control Strategy - Webinar Recording

Annex 1 - Quality Risk Management using the example of the Contamiation Control Strategy - 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

Dr Franz Schönfeld, GMDP Inspector for EMA and local authorities, 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, which resulted in thousands of comments. A revised second version was published in February 2020 and is open for limited comment by selected stakeholders.

Target Group

 This webinar is addressed to employees of pharmaceutical and biopharmaceutical manufacturers, authorities and suppliers with responsibility in
  • Quality assurance and quality control
  • Inspections and audits
or who are active in
  • Sterile/aseptic production
  • Contamination control and monitoring
  •  Process Simulation/Media Fill

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 teaches the basics of quality risk management and its practical application using the example of contamination control (CCS Contamination Control Strategy) according to the current draft for the revision of Annex 1 of the EU GMP guidelines. It explains the importance and the networking of risk-minimizing measures in the areas of personnel, design and processes within the overall concept of avoiding microbial contamination for the efficient planning and production of sterile dosage forms. Accordingly, this webinar covers the core requirements for
  • Quality Risk Management
  • Contamination Control Strategy
  • Personnel
  • Design
  • Process flows
 
 
Recording from 23 July 2020
Duration of Recording: Appr. 1,5 h

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