Pre-Course Workshop: Impact of Annex 1 Revision on Cleaning Validation - Online Training Recording

Pre-Course Workshop: Impact of Annex 1 Revision on Cleaning Validation - Online Training Recording

Costs

ECA-Member*: EUR 490,--
Regular Fee*: EUR 690,--
EU/GMP Inspectorates*: EUR 345,--
APIC Member Discount*: EUR 590,--

(All prices excl. VAT). Important notes on sales tax.

* 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

Robert G. Schwarz, FH Campus Vienna, Austria

Objectives

With the revised version of Annex 1 coming into force in August, this workshop aims at giving you an overview of important changes that impact cleaning and Cleaning Validation which may not be seen at the first glance. As integral topic of the new Contamination Control Strategy (CCS), it will also be in the main focus of authorities during inspections of sterile medicinal products. Some of the strategies in Annex 1 may even become “state of the art” for non-steriles in the upcoming years. This is already explicitly mentioned in scope of the new Annex 1. It will be elaborated how to align your Cleaning Validation strategy with this, highlighting points to consider when implementing those changes in requirements into your daily Cleaning Validation business.

Background

The Annex 1 Revision of the EU GMP Guide was finalised in 2022. Previously there were two drafts (2017 & 2020), now the final version will come into force at 25th August 2023. The new Contamination Control Strategy (CCS) hugely affects Cleaning Validation.

Target Group

The Pre-Course Workshop and the Main Course both are directed at staff of R&D, production and quality assurance involved in cleaning validation. They also address engineering companies and manufacturers of cleaning devices/equipment interested in learning more about the pharmaceutical industry’s viewpoint and in exchanging experiences.

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

With the Pre-Course Workshop we cover:
  • Regulatory requirements of Annex 1 regarding Cleaning Validation & Cleaning (incl. potential topics stated “between the lines”)
  • Annex 1, Annex 15 and EMA “Shared facilities Guideline” – harmonized, extended requirements or even contradictions!?
  • Annex 1 & Cleaning Validation – practical approaches
Recording from 21 March 2023
Duration of the recording: approx. 2 h 23 min

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