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On the afternoon of Sunday, 2 September, ISPE is pleased to present two workshops, which will run concurrently from 1:30 p.m. to 5 p.m., finishing just in time for the Welcome Cocktail Reception at 5:30 p.m.!
Workshop 1 - Science and Risk-based Approaches to Computer Systems Compliance
Internationally acclaimed computer systems compliance expert and editor of the GAMP Guide for Validation of Automated Systems, Sion Wyn, will lead this workshop and provide a detailed drill-down on how to apply GAMP5 principles to the validation of Enterprise Resource Planning (ERP) and other IT systems. Areas to be covered include quality risk management, risk assessment in practice, record and data integrity, effective and efficient lifecycle activities, GAMP5 special interest topics, new guidance on operational aspects, and outsourcing IT. Come along to get the most-up-to-date insight into the evolution of the GAMP5 guidance from Wyn and see how it fits into wider ISPE and industry initiatives.
Workshop 2 – Risk-based Management – Practical Steps in Assessing, Quantifying and Managing GMP Compliance Risks
With more than 34 years quality assurance, manufacturing and consulting experience in the biotechnology, pharmaceutical and medical device industries, SeerPharma Director Steve Williams, will lead this workshop. He will draw on his extensive experience to provide case studies and practical examples on how to assess, quantify and manage compliance risks from a GMP perspective. Williams delivered a similar workshop at the ISPE conference in Singapore in June, which attracted more than 80 delegates and was very well received.
A Plenary session will be held on the morning of 3rd Sept. Confirmed Plenary Session Speakers:
• Steve Williams, ISPE/Asia Pacific’s CPIP Commissioner
• Carl Fearn, Area Vice President Australia and New Zealand,IMS Health
• Dr. Mark Doverty, Head of TGA’s Manufacturers Assessment Branch, TGA
Monday 3rd Sept and 4th Sept will cover 3 streams a) Facility Life Cycle Innovation b) Manufacturing Excellence and c) Compliance.
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