GMP-compliant Operation of HVAC Systems - Webinar Recording

GMP-compliant Operation of HVAC 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

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 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 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
Recording from 24.06.2020
Duration of recording: approx. 1.5 h.

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