Annex 1 - New Requirements for Clean Rooms & HVAC Systems - Webinar Recording

Annex 1 - New Requirements for Clean Rooms & HVAC Systems - Webinar Recording

Costs

ECA-Member*: EUR 199,--
Regular Fee*: EUR 249,--

(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 Jean-Denis Mallet, Former head of the French Inspection Department AFSSAPS, Pharmaplan

Background

Annex 1 of the EU GMP Guide “Manufacture of sterile medicinal products” is the most important guideline for sterile manufacturing of medicinal products. It is currently under revision with a first version having been published for public comments in 2017. After thousands of comments had been received a revised version was published in February 2020 which is now open for commentation by selected stakeholders. Many changes can be found in the new document especially when compared to the former official version of the Annex 1. This is also true for the premises, clean rooms and HVAC systems which are necessary to ensure aseptic/sterile conditions.

Target Group

The target group of this webinar are professionals in engineering, production and quality assurance responsible for setting up or operating GMP-compliant premises for the manufacture of sterile medicinal products.

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.

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

In this webinar it will be shown where the differences and new requirements are, compared to former versions of the EU GMP Annex 1:

Premises
  • Supervision from outside the critical cleanrooms
  • Clarification on the need for several airlocks and the related transfers
  • Management of differential pressure  (cascade or not)
  • The importance of visualisation of the airflow patterns
  • Disinfection of cleanrooms
HVAC-Systems
  • Electronic particulate counting ... and microbial, too ?
  • What is cleanroom classification, cleanroom qualification, cleanroom monitoring?
Equipment
  • Anticipating the progressive disappearing of the classical clean rooms
  • Sterilization or disinfection of equipment
Utilities
  • More detailed requirements from the new Annex 1
Recording from 09.06.2020
Duration of recording: approx. 1,5 h.

Go back

Online Training & Webinar Recordings by topic