Nikolaus Ferstl, University Hospital of Regensburg, Germany
Dr Lars Kreye, Boehringer Ingelheim, Germany
André Lourenco, NNE, Denmark
Dr Jean Denis Mallet, Former Head of the French Pharmaceutical Inspection Dpt. AFSSAPS, France
Andreas Nuhn, D&B Pharmadesign, Germany
Knowing the regulatory requirements on rooms and HVAC systems is an absolute prerequisite for all further steps like design, qualification and operation of clean rooms.
It is therefore essential to be aware of all restrictions and relations between material and personnel flows before starting with the building of clean rooms for pharmaceutical manufacturing. This is the starting point for the zone concepts and the required airlocks.
The clean room itself consists of floor, wall and ceiling systems suitable for the intended use. Now, which systems are suitable for which clean zones or processes? How can an isolator be integrated in the concept?
The classification and qualification of the rooms have to be done after the construction. The formal requirements on qualification are the same for clean rooms dedicated to the manufacture of both sterile and non-sterile dosage forms. Only the contents to be examined and fulfilled are different.
Qualification – which serves the verification of the correct functioning of the production rooms – merges into the routine monitoring. Moreover, the systems in place for requalification, change control, deviation and maintenance ensure the GMP status to be kept.
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.
Please be aware: The recording does not include the Q & A sessions.
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.