Affiliate Past Events

2008 Events

12 September 2008
Workshop at Bosch / Crailsheim: “Containment/ asept. Filling of liquid products” (case studies, disposable filling systems, Isolator technology and lyophylisation)24-25 June 2008
9. PAT CoP D/A/CH Meeting

4 September 2008
Workshop / site visit at Hermes in Wolfsberg/A: “New technologies in manufacturing effervescent tablets”

24-25 June 2008
9. PAT CoP D/A/CH Meeting

30 May 2008
Workshop and site visit at Excelvision in Hettlingen/CH: “Aseptic fill and finish of eyedrops : “GMP upgrade and modular extension of production facility”

3/4 April 2008
Annual membersip assembly of D/A/CH in combination with workshop at Sartorius in Göttingen (Topic: Disposable Technology in the biopharmaceutical Production)

3-4 March 2008
Fachdiskussion ‘Containment’ (Topic: ‘Actual requirements  and risk assessment for containment facilities’) with target to start a local ‘CoP Containment’
at Novotel Freiburg, Am Konzerthaus

24./25. Januar 2008
Liebe Kolleginnen und Kollegen der ISPE Affiliate Deutschland / Österreich / Schweiz (D/A/CH), als Anlage senden wir Ihnen unser Einladungsschreiben und die vorgesehene Agenda zum Fachgespräch Projektmanagement „Aller Anfang ist schwer … Projekte erfolgreich initiieren"  am 24/25 Januar 2008 im Hotel "Novotel" in Mainz.

Zur Online-Anmeldung nutzen Sie bitte das ADOBE-Formular oder das Telefax-Formular. Sie finden beide Dateien sowie weitere Details in der Anlage.

17 January 2008
Regional ISPE PAT CoP D/A/CH
8. PAT CoP D/A/CH Meeting
at Boehringer Ingelheim, Ingelheim

2007 Events

20/21 November 2007
Panel Discussion "Containment"

5/6 November 2007
COP "Monitoring of Water- and Steam Systems"
More information (German)

After our success with the 1st event about “Rouging” in 2006 our rCOP “Water & Steam” decided to organize a further event about monitoring in water and steam systems. This topic was requested by the ISPE D/A/CH members based on a questionnaire which was sent out earlier.

The event took place in a special atmosphere due to the location in the hotel Bayarena within the football stadium of Bayer Leverkusen and reflected the key issues for monitoring from the following point of views:

• Regulatory requirements
• Chemical/physical aspects
• Microbiological aspects
• Online/offline
• PAT

For each issue an initial presentation was made. For the regulatory requirements we had the chance to listen to a speech of Mrs. Isabelle Mercier from EDQM Strasbourg which is the official representative for the European Pharmacopoeia. For the other topics we had speakers from the pharmaceutical industry in order to highlight the current state-of-art to the participants at this event.

16 very interested participants discussed possible directives for monitoring issues during these two days. Our next target is to create a newsletter within 2008 which is based on the results and discussions of this expert meeting. This newsletter is intended to be a tool for the users in industry and will be available on the website of the local ISPE DACH affiliate.

12 October 2007
One day event: Lectures in the Morning, Plant Tour in the Afternoon
Workshop “Electronic Batch Record (EBR)”
Subtitle: “The Paperless Batch Record – Vision or Reality?”
36 Participants, 5 Speakers
CILAG AG (Johnson & Johnson), Schaffhausen, Switzerland

1. Prof. Dr. H. Hensel, Techn. College Harz
   Further Development of the GAMP-Guideline with preview to GAMP 5
2. Ch. Wölbeling, WERUM AG
   PQLI/PAT/QbD-Initiative of the FDA; Activities of the ISPE PAT CoP D/A/CH
3. Dr. T. Slawinski, Bayer Tech. Services
   Integrated Factory Management Systems: Yesterday, today, tomorrow
4. Dr. A. Meyer, Dr. N. Tröndle CILAG AG
   Case Study CILAG AG: EBR based on an integrated SAP solution
   Afternoon: Demonstration of the EBR on the live system at CILAG AG.

11/12 October 2007
Workshop Electronic Batch Recording
"Die Papierlose Pharmaproduktion - Vision oder Realität?"

10/11 September 2007
"Expertentreffen bei SBM"

10/11 May 2007
Workshop on "Production of diagnostics and oral dosage forms production and the engineering, construction and implementation of process units "

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