Webinar GMP-compliant Operation of HVAC Systems

Webinar GMP-compliant Operation of HVAC Systems

Course No 18019

Important: Deadline is 12 noon on 23 June 2020

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Speakers

Fritz Röder, Merck Healthcare KGaA

Background

Not any pharmaceutical facility can be operated without an HVAC system, no clean room can be qualified without considering the HVAC system. And: HVAC systems operated in a wrong way can lead to cross-contamination in the worst case. But one is for sure: shut down of the HVAC systems leads also to shut down of the pharmaceutical production where a controlled environment is required - no matter whether the problems were caused by compliance or technical reasons.

But experts in the HVAC field are often quite technically oriented, and “HVAC Compliance” is often neglected. How critical is pressure change in a room? And how much can you reduce the air change rate in non-production times in a cleanroom? How often do you have to repeat qualification measurements like air velocity or smoke studies?

Target Group

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

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 technical and GMP issues of HVAC systems (sterile & non-sterile) and possible solutions are shown. In addition frequently asked questions in inspections are discussed:
  • Good design can only be achieved in advance: what can be optimised later on?
  • Repetition of qualification measurements: how and how often?
  • Mistakes and their remediation: root cause analysis
  • Compliance questions from oral solids, semi-solids and sterile manufacturing
  • Typical questions from GMP inspections and possible answers

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