Isolator Conference - with workshops at SKAN (Day 3 only)
Speakers
Claudio Bechini, Pharma Integration
Dr Andreas Flückiger, F. Hoffmann-La Roche
Dr Friedrich Haefele, Boehringer Ingelheim
Dr Timo Krebsbach, HHAC Labor Dr. Heusler
Dr. Jörg Lümkemann, F. Hoffmann-La Roche
Elodie Muller, Confarma
Jean-Sébastien Parisse, Aseptic Technologies
Benoît Ramond, Sanofi
Lionel Rapin, GSK Vaccines
Dr Lars Restetzki, F. Hoffmann-La Roche
Dr Andreas Schreiner, Novartis Pharma
Thomas Zinn, Sandoz
Objectives
This is why you will benefit from attending this conference:
Presentations of the experiences of various specialists working with innovations and state-of-the-art equipment within pharmaceutical industry and microbiology
Experts from pharmaceutical companies will share their knowledge regarding operational experience. E.g.:
trends in laboratory and environmental monitoring,
new decontamination processes and small scale production,
market trends, requirements and operation of
production isolators.
Case studies from various pharmaceutical companies deal with the implementation, qualification and operation of isolator and RABS systems.
You will discuss the current state-of-the-art and new technological developments in Barrier Systems technology.
You will participate in active workshops based on usual aseptic and aseptic-toxic manipulation.
Target Group
This event is directed at decision-makers from pharmaceutical production, development and quality assurance/control. It also addresses engineers, technicians, and planners who need to be well informed about current developments in the field of barrier systems.
Please understand that, for competitive reasons, not all firms can register their employees for this event.
Workshops at Skan
The workshops will take place at SKAN AG in Allschwil. After lunch on 31 May and 1 June a bus shuttle service will bring the participants to SKAN.
After the workshops at 17.00 h, the bus shuttle will bring the participants to the airport, the train station or back to the venue.
At the end of 2 June a bus will bring the participants to the airport or to the train station.
Programme
Programme
Day1 - Laboratory and environmental monitoring, Tuesday, 31 May 2016
History, future and regulatory trends in sterility testing
Elodie Muller, Confarma
Roche containment: High-Potency-API – regulatory requirements
Dr Andreas Flückiger, F. Hoffmann-La Roche
Case study HHAC: Microbiology in isolators
Dr Timo Krebsbach, HHAC Labor Dr. Heusler
Case study Sanofi: Environmental monitoring program: hot topics in microbiology & best practice
Benoît Ramond, Sanofi
Workshops at SKAN
Sterility testing in an isolator
Environmental monitoring in an isolator
Service: qualification of an isolator
SCADA solution for isolators
Day 2 - New decontamination process and small scale production, Wednesday, 1 June 2016
The actual trends in isolator technology
Philippe Jérôme
SKANFOG, the future decontamination system
Volker Sigwarth
Case study GSK: Design of isolators for aseptic
processes
Lionel Rapin, GSK Vaccines
The isolator solution for flexible small scale production
Frank Lehmann
Different applications for flexible small scale production
Paul Ruffieux, Consultant
Case study Boehringer Ingelheim: Filling of ready-to-use vials in an isolator
Dr Friedrich Haefele, Boehringer Ingelheim
Workshops at SKAN
E-Beam: Surface decontamination of tubs
Production filling line isolator
Flexible small scale filling isolator
Glove tester for isolators and RABS
Isolator Academy and bio indicator production
Containment isolators and innovative safe change filter
Day 3 - Production isolators, Thursday, 2 June 2016
Alternative morning session: parallel visits of sterility test laboratories at Roche Kaiseraugst. The number of participants is limited.
Case study: Filling isolator with freeze dryer
Case study Roche: Occupational hygiene measurements in isolators for parenteral manufacturing
Dr Lars Restetzki, F. Hoffmann-La Roche
Pharmaceutical processes with robotics in isolators
Claudio Bechini, Pharma Integration
Case study Sandoz: E-Beam filling line with isolator
Thomas Zinn, Sandoz
Cleaning requirements based on the new EMA guideline
Dr Andreas Schreiner, Novartis Pharma
Closed vial filling from R+D to market
Jean-Sébastien Parisse, Aseptic Technologies
RABS retrofit for improving aseptic processing quality
Manfred Holzer
This course is part of the GMP Certification Programme "ECA Certified Sterile Production Manager" Learn more
This training/webinar cannot be booked. Send us your inquiry by using the following contact form.
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.
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Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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