Biotech China 2014
4th Annual Aseptic Filling and Processing
Angelo Hotel Prague
Prague
Czech Republic, xx
http://www.informa-ls.com/aseptic
4th Annual Aseptic Filling and Processing
http://www.informa-ls.com/aseptic
Angelo Hotel Prague
Prague
Czech Republic

Schedule of Presentations:

Tuesday, January 27, 2009
08:30:00 Coffee and registration
09:00:00 Opening remarks from the Chair Gordon Farquharson
09:10:00 IMPLEMENTING THE REVISED EU GMP ANNEX 1
09:10:00 Regulatory review of the Annex 1 revisions Tor Graberg
09:50:00 Case study 1: Changes to the airborne particulate classification table – interpretation and practical issues for cleanroom operation Tim Eaton
10:30:00 Morning coffee
11:00:00 Case study 2: Bioburden monitoring
11:40:00 Case study 3: Media simulations
12:20:00 Q&A session: Implementing the revised Annex 1
12:35:00 Lunch
13:50:00 Setting up, running and assessing facilities and processes to ensure efficient energy management: Simultaneously protecting the environment and the company’s bank balance Gordon Farquharson
13:50:00 EXTERNAL & GLOBAL PRESSURES ON THE ASEPTIC PROCESSING COMMUNITY
14:30:00 The rise of low cost manufacturing and the impact that it is having on the aseptic processing community: Building vendor assurance programmes into your risk assessment Rob Walker
15:10:00 Q&A Session
15:25:00 Afternoon tea
15:55:00 Spotlight session
16:25:00 SEPARATIVE DEVICES
16:25:00 Case study 1 | Implementation of 9 isolators in highly active facilities for semi-solid and parenteral drug products: multiple purpose concept, decision criteria and main project phases. Dieter Roethlisberger
17:05:00 Case study 2 | Selecting and incorporating a RABS into a filling line: Examination of the crucial steps to ensure a successful manufacturing facility
17:45:00 Closing remarks from the Chair Gordon Farquharson
17:50:00 End of conference Day One
Wednesday, January 28, 2009
08:30:00 Coffee
09:00:00 Opening remarks from the Chair Gordon Farquharson
09:10:00 Status of the proposed revisions to the guidelines on dedicated facilities: Examination and explanation of the rationale behind the changes and how they will facilitate sterile fill and finish processes Jürgen Fleckenstein
09:10:00 CHANGING GUIDELINES, REGULATIONS & BEST PRACTICES
09:50:00 ICH Q8. Q9 & Q10: A one stop and critical update on the aspects you should be aware of Barbara Sambuco
10:30:00 Morning coffee
11:00:00 Establishing an effective environmental monitoring programme to achieve quality and perfect compliance Mike Wassall
11:40:00 Q&A Session
11:55:00 Spotlight session
11:55:00 CHOICE OF PROCESS & FACILITY EQUIPMENT
12:25:00 Lunch
13:45:00 When to best use disposable and reusable equipment in isolator filling lines Franck Pavan
14:25:00 Thoughts on how to design and plan HVAC for a new facility in the most energy efficient manner Ulla Thomsen
15:05:00 Afternoon tea
15:25:00 High level 6log sporicidal disinfection using vapour technology for rooms, RABS and isolators James Drinkwater
16:05:00 Isolator liquid filling technology: case study on a high speed line equipped with a PAT feature and integrated with MES Mauro Giusti
16:45:00 Q&A session
17:00:00 Closing remarks from the Chair Gordon Farquharson
17:05:00 End of conference
4th Annual Pharma R&D Asia Congress
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