Recording Webinar: GMP-compliant Operation of Pharmaceutical Water Systems

Recording Webinar: GMP-compliant Operation of Pharmaceutical Water Systems

Costs

ECA-Member: EUR 199,--
Non ECA Member: EUR 249,--

(All prices excl. VAT)

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 Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

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: 1,5 h.

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