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

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

Course No 18111

Important: Deadline is 12 noon on 22 July 2020

You will find all webinars of this series in this overview

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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 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

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

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