GMP-compliant Operation of Pharmaceutical Water Systems - Webinar Recording

GMP-compliant Operation of Pharmaceutical Water 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

 Fritz Röder, Merck Healthcare KGaA

Background

Pharmaceutical Water is unique and comprises a lot of special circumstances that are not common in the GMP area. There is no test for identity, the process is running continuously and cannot be switched off – except for maintenance reasons. That is the reason why many question arise day by day concerning operation & compliance. And this can become critical for the manufacture of medical products. Water in pharmaceutical quality is used in many processing steps and in almost every manufacturing process of pharmaceutical products. And here, no matter whether the water system is shut down for technical or compliance reasons: the pharmaceutical production is shut down also.

Target Group

This webinar aims at persons responsible for the trouble-free  technical and GMP-compliant operation of pharmaceutical water systems - especially from production, engineering and QA or Microbiology.

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 the webinar, typical mistakes and problems from the daily business are explained, frequent questions from inspections are discussed and answered. Is your water system compliant? How long do you allow your water loop to stop until you have to start an investigation? And what is the minimum Reynolds number during normal operation? How often do you have to take samples after an microbiological OOS result?
  • How to set up a suitable control strategy
  • Problems and their remediation: root cause analysis in water systems
  • Common compliance questions in practice
  • Typical questions and possible answers in inspections
Recording from 17.06.2020
Duration of recording: approx. 1.5 h.

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