GMP-Webinar: GMP Update 2016/2017

GMP-Webinar: GMP Update 2016/2017

Course No 15642


Costs

This conference already took place.

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

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

To be able to take part in a Webinar, you need a computer with high-speed Internet access (i.e. DSL) and speakers.

Your Internet browser must have following features to use the GMP Webinar system:
1. Adobe Flash-Player must be installed.
2. Javascript must be allowed.
3. Port 1935 must be released.

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 Directives
  • EU-GMP Guide (e.g. Annexes 1, 16, 17, 21)
  • News from FDA (e.g. Update Quality Metrics)
  • News from Europe (e.g. Data Integrity, WFI production)
  • News from ICH (Guideline on Elemental Impurities and its implementation in the different regions)
  • 2017 outlook

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