This one-day event will feature presentations & interactive sessions that examine the multiple facets of single-use systems (including filtration) lifecycle management including an in-depth review of current global regulatory practice for filtration applications in aseptic processing, tips and tricks and other hot topics such as Pupsit, etc.
graduated as a Chemical Engineer from University of New South Wales majoring in bioprocessing, including a three-year postgraduate research program in membrane characterization and production. Michael joined Millipore (now Merck Millipore) in 1980 and served in a variety of positions including regional management (3 years), technical support management (3 years), validation protocol writing and execution (5 years), technology management (5 years), and the head of Technical and Customer Training in Bedford Mass (10 years).
Now he is the principal technical consultant working in Asia focusing on validation, regulatory, sterilization, integrity testing and process consulting. During the last 12 years, Michael has presented at a number of ISPE and PDA meetings in the region delivering materials on quality, process efficiency, single-use technology, qualification, and sterile compliance. He has also been involved in generic technical education for inspectors and reviewers in several countries across Asia.
Quality and validation specialists, engineers, technical professionals, managers and vendors who develop, use, support or validate.
|08:45 - 09:00||Registration|
|09:00 – 09:10||Welcome & Introductions|
|09:15 – 10:10||Potential Impact of Draft Annex 1 on Sterilising Filtration &
|10:10 – 10:30||Break|
|10:30 – 11:30||Review of Some Important Elements of Supplier Quality for Drug Lifecycle Management|
|11:30 – 12:30||Extractable and Leachable
Validation Considerations for Single-use Implementation
|12:30 – 13:30||Lunch|
|13:30 – 14:30||Technological and Engineering Innovations around Compliant Sterile Medicinal Product Manufacture & Scaling|
|14:30 – 14:45||Break|
|14:45 – 16:15||Workshop team Breakout - Risk Assessment, Change control and Quality Deviation Response|
|16:15 – 16:30||Wrap Up & Close|
NB – Final program subject to change without notice