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Event Details

Michael Payne 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.


 Overview

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. 


Who Should Attend?

Quality and validation specialists, engineers, technical professionals, managers and vendors who develop, use, support or validate. 


Agenda

08:45 -  09:00Registration
09:00 – 09:10Welcome & Introductions
09:15 – 10:10Potential Impact of Draft Annex 1 on Sterilising Filtration & Single Use Systems
10:10 – 10:30Break
10:30 – 11:30Review of Some Important Elements of Supplier Quality for Drug Lifecycle Management
11:30 – 12:30Extractable and Leachable
Validation Considerations for Single-use Implementation
12:30 – 13:30Lunch
13:30 – 14:30Technological and Engineering Innovations around Compliant Sterile Medicinal Product Manufacture & Scaling
14:30 – 14:45Break
14:45 – 16:15Workshop team Breakout - Risk Assessment, Change control and Quality Deviation Response
16:15 – 16:30Wrap Up & Close

NB – Final program subject to change without notice 

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Location
Courtyard Sydney North Ryde

7-11 Talavera Road Macquarie Park Ryde 2113, Australia


Organiser Information

Mandy Bromilow
ISPE
0447 279 008

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