GMP Update 2022/2023 - Webinar Recording

GMP Update 2022/2023 - Webinar Recording

Costs

ECA-Member*: EUR 249,--
Regular Fee*: EUR 299,--

(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 Rainer Gnibl, GMP Inspector

Background

One might easily get the impression that the GMP world is continuously turning faster. Laws, regulations, and especially GMP requirements of the EU are constantly renewed, modernised and (allegedly) adapted against each other. The effects of the pandemic and the Brexit bring additional demands. 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 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.

Please be aware: The recording does not include the Q & A sessions.

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 aims at giving you a comprehensive but still compact overview about the many innovations in the GMP area – those already realised and those planned:
  • Veterinary medicinal products: GMP-relevant changes and adaptations
  • New developments in the EU: Annex 1; quality requirements for investigational medicinal products
  • FDA (OOS and Draft Guidance for Industry Computer Software Assurance)
  • ICH Q9, ICH Q2 (R2), ICH Q14 and ICH Q5A (R2)
  • Outlook for 2023
Recording from 9 December 2022
Duration of the recording: approx. 1.5 h

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