Annex 1 - Sterilization and Sterile Filtration - Webinar Recording

Costs

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

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

Registration

* also payable by credit card

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 for EMA and local Government, Germany

Background

Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment, resulting in thousands of comments. A revised version was published in February 2020 and is open for limited comment by selected stakeholders.

Target Group

This Webinar is of interest to professionals from pharmaceutical and biopharmaceutical manufacturers, authorities and suppliers with responsibilities in

Quality Assurance and Quality Control
Inspection and Auditing

or who are involved in

Sterile/Aseptic Manufacturing
Contamination Control and Monitoring
Process Simulation/Media Fill

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

This webinar will inform you about the current status of the revision regarding changes and enhancements in the field of sterilization and sterile filtration. As an example, the filter test is mentioned. “The integrity of the sterilized filter should be checked before use” is stated in Annex 1. In this context, the requirement for the Pre-Use-Post-Sterilization Integrity Test (PUPSIT) is made to avoid “blinded” filter errors in the pure post-filtration test. For this purpose, it was discussed whether the risk of not using PUPSIT was lower than the risk of the integrity test negatively affecting the performance of the sterile filter. Accordingly, the webinar deals with the following topics:

Definitions
Requirements
Validation
PUPSIT - Pre-Use-Post-Sterilization Integrity Test

Recording from 28 May 2020

Duration of recording: 1,5 h.

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