Applied Statistics
Process Validation and Verification for Medical Devices
Excelsior Hotel Ernst,
Trankgasse 1-5 / Domplatz,
Cologne,, Germany
Process Validation and Verification for Medical Devices
Informa Life Sciences’
Excelsior Hotel Ernst,
Trankgasse 1-5 / Domplatz,

Schedule of Presentations:

Tuesday, December 2, 2008
08:00:00 Registration and morning coffee
08:25:00 Chairman’s opening remarks
08:30:00 Verification vs. validation Daniel Cooper,
09:10:00 The use of validation as a competitive advantage Arnya Traher,
09:50:00 Writing the Validation Master Plan (VMP) Frank Peeters,
10:30:00 Networking break
11:00:00 Design transfer Lan Nguyen,
11:40:00 Spotlight session
12:20:00 Lunch
14:00:00 Validation and process consistency Ian Abrahams,
14:40:00 How to determine which processes need validation based on design process outputs Robert Van Boxtel,
15:20:00 "True" risk management at Coloplast Asger Dahlgaard
16:00:00 Networking break
16:30:00 Using computer systems and their power to improve the execution of validation José Mora,
17:10:00 Elements reviewed during audits on validation processes Robert Van Boxtel,
17:50:00 Question and answer session
18:00:00 End of day one
Wednesday, December 3, 2008
08:30:00 Morning coffee
08:45:00 Chairman’s welcome back to day two Denys Durand-Viel,
08:50:00 Regulatory optimal flow vs. manufacturer optimal flow Jim Clossick,
09:30:00 Equipment development and qualification for pharma, biopharm and devices: Differences, similarities and opportunities Jan C. Crielaard,
10:10:00 Networking break
10:40:00 Verification and validation using simulations: Automated insulin delivery examples Ludovic J Chassin,
11:20:00 Developing a decommissioning process Mathijs ten Berg,
12:00:00 Learn to assess the validation system with Six Sigma and lean tools Mathijs ten Berg,, Jan C. Crielaard,
13:00:00 Lunch
14:00:00 Cleaning validation with a focus on home-use re-use devices Anette Sjögren,
14:40:00 Clean rooms validation: a practical approach Thomas Salomon,, Denys Durand-Viel,
15:20:00 Networking break
15:45:00 Computer system validation Bibi Klingenberg,
16:25:00 Custom software validation for equipment Ivan Vecerina,
17:05:00 Validation as a key tool in the successful transfer or establishment of a medical device company in a new facility Oren Levin,
17:45:00 Chairman's closing remarks and end of conference
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