GMP-Webinar: GMP Update 2018/2019

GMP-Webinar: GMP Update 2018/2019

Course No 16880

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Speakers

Dr Bernd Renger
Dr Renger is Immediate Past Chair of the European QP Association. Prior to that he was VP Quality Control at Vetter Pharma-Fertigung GmbH. He began his career at Hoechst AG in 1977 and has held various management positions in the quality area at Mundipharma, Byk Gulden (today Takeda) and Baxter BioScience AG in Vienna.

Background

One might easily get the impression that the GMP world is continuously turning faster. Laws, regulations, and especially GMP or GDP requirements of the EU are constantly renewed, modernised and (allegedly) adapted against each other. To provide you with an overview is thus the goal of this webinar.

Target Group

The webinar targets executives and staff in the pharmaceutical industry, who want to get a compact but yet comprehensive overview of all recent changes in the GMP requirements.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.htm 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 aims at giving you a comprehensive but still compact overview about the many innovations in the GMP area - those already realised and those planned:

  • EU-GMP Guide (e.g. Annexes 1, 2, 17, 21)
  • Update FDA/ EU MRA
  • The revised MRA with Switzerland
  • Status EU Clinical Trial Regulation and guidance
  • Brexit and its consequences for pharma
  • 2019 outlook



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