Annex 1 - Application of Disinfectants and their Validation - Webinar Recording

Annex 1 - Application of Disinfectants and their Validation - 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 Thomas Meindl, Specialist consultant for pharmaceutical microbiology, Laboratory LS SE & Co. KG, 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, which resulted in thousands of comments. A revised version was published in February 2020 and is open for limited comment by selected stakeholders.

Target Group

This conference is of interest to professionals from pharmaceutical and biopharmaceutical manufacturers, authorities and suppliers with responsibilities in
  • Aseptic Manufacturing, Quality Assurance, Quality Control, Auditing, Inspections
who are involved in
  • Contamination Control, Monitoring, Qualification and Validation, Self Inspection, Quality Affairs, 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 requirements for the use of disinfectants in pharmaceutical production, which are formulated in more detail in the new Annex.

Starting from a qualified cleaning, a disinfection strategy must be developed and validated as part of the Contamination Control Strategy. The validation shows that the methods, processes and materials described lead to the desired result under the individual clean room conditions. An important prerequisite for this is up-to-date data on the respective house germ flora. The selection of disinfectants is based on the results of operational hygiene monitoring as well as on risk-based approaches, which can be used to plan the frequency of use and the selection of disinfectants.
  • Inhouse Isolates as a basis for decision-making for a risk-based approach
  • Suitable disinfectant validation
  • Evaluation of disinfectant studies
 
Recording from 15 July 2020
Duration of recording: about 1,5 h

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