Programme

Education Programme

Monday 13 November 

PLENARY: Regulatory Requirements & Compliance
0900 Welcome & Opening Remarks Geoff Brown, President, ISPE Singapore
0910 Chairman’s Remarks  
0915 Overview of Data Integrity in the Full Product Life Cycle Frances Zipp, President & CEO, Lachman Consultant Services, USA
1000 KEYNOTE: Current Regulatory Trends and FDA's Guidance for Industry Data Integrity and Compliance with CGMP Karen Takahashi, Senior Policy Advisor, US FDA CDER OPQ
1045 Morning refreshments  
1115 KEYNOTE: Data Integrity, the Challenges to Meeting Regulatory Requirements Ian Thrussell, former WHO GMP & UK MHRA Expert Inspector, Switzerland
1200 Panel discussion: Challenges to Data Integrity in Emerging Markets Moderator: Tony Margetts, Compliance Manager, Factorytalk, Thailand & Speakers
1245 Lunch  
Industry Best Practices
1345 KEYNOTE: Addressing Data Integrity Across Global Organisations; Regulations, Systems and People Michael Rutherford, Consultant - Laboratory and Quality Systems, Medicines Development Unit (MDU) - Business Systems Support, Eli Lilly and Company, ISPE GAMP Global Chair & GAMP Data Integrity SIG Sponsor, USA
1430 Quick Wins for Data Integrity Compliance: GAP Assessment  Christopher Reid, CEO, Integrity Solutions Limited, UK
1515 Afternoon refreshments  
1545 Application Workshop: Risk-based Approach to Records and Data Integrity Charlie Wakeham, Informatics CSV Consultant, Waters Asia; ISPE GAMP, Australia
1630 Quick Wins for Data Integrity Compliance: Audit Trail Edit Szöcs, Auditor & Consultant, Merck Biopharma, Switzerland
1715 Panel Discussion / Q&A Moderator: Michael Rutherford, Consultant - Laboratory and Quality Systems, Medicines Development Unit (MDU) - Business Systems Support, Eli Lilly and Company.
Speakers & Georg Singewald, Head Quality, Solids & Special Technologies, Novartis Pharmaceuticals Asia Pacific, Singapore
1745 End of Day 1  
1800 Evening Under the Stars at Gardens by the Bay (separately bookable)  

 

 Tuesday 14 November

Data Integrity & Enabling Technologies
0850 Chairman’s Remarks  
0900 MES – Why and How Asia is Moving Towards Meeting Data Integrity Requirements Electronically David Margetts, Managing Director, Werum IT Solutions, Thailand
0930 Advancing Cybersecurity Strategies for Systems Lifecycle Management: Challenges to Data Integrity & Controls Jason N. Young, Principal Cyber Security Architect, Silver Bullet Security, Australia
1000 Assuring LCMS Data Integrity in Regulated Pharmaceutical and Bioanalytical Workflows Dave Abramowitz, Director for Compliance, Software and Professional Services, SCIEX
1030 Morning refreshments  
1100 Application Workshop: Auditing for Data Integrity Charlie Wakeham, Informatics CSV Consultant, Waters Asia; ISPE GAMP, Australia
1145 Panel discussion: Investigating Potential Data Integrity Incidents, Methods and Tools Moderator: Pierre Winnepenninckx, CEO, No deviation, Singapore 
Panellists: Speakers from morning & Lim Fu Chin, Halfmann Goetsch Partner, Singapore
1230 Lunch  
Data Integrity Execution & Risk-Based Approach
1330 Learning from Implementing eCTD and Data Integrity in the Clinical Environment Emily Tan, Corporate Vice President, Portfolio Leadership, Parexel, Singapore
1415 Case Study: Addressing Company Data Integrity Challenges Guy Wingate, VP & GMS Compliance Officer, GlaxoSmithKline, UK
1500 Afternoon refreshments  
1530 Case Study: Data Integrity Risk Assessment in Computerised Systems in a Manufacturing Environment Willy Susanto, Senior Data Integrity & CSV Engineer, Abbvie Singapore
1615 Panel Discussion / Q&A: Risk-Based Approach to Computerised System Compliance and Data Integrity Moderator: Guy Wingate, VP & GMS Compliance Officer, GlaxoSmithKline, UK Panellists: Speakers of the day &Pierre Winnepenninckx, CEO, No deviation, Singapore
1700 Close of conference  

Programme Changes

Last minute changes due to functional, private, or organisational needs can be necessary. The event organiser accepts no liability for any additional costs caused by a change of programme. Programme is subject to change.

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