GMP-Webinar: GMP Update 2015/2016

Tuesday, 08 December 2015, 15.00 – 16.30 h CET

Course No 10335

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Speakers

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

Objectives

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
- Chapters 3, 5, 6 and 8
- Annexes 1, 15, 16
Guidelines on GDP for APIs
Guidelines on risk assessment for excipients
News from FDA
MHRA’s Data Integrity Guidance
2016 outlook

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 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.

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