ISPE 2017 Asia Pacific GAMP Data Integrity Conference

Education Programme

Monday 13 November 

PLENARY: Regulatory Requirements & Compliance

0845 Opening Remarks from the Chair Geoff Brown, President, ISPE Singapore
0945 Overview of Data Integrity in the Full Product Life Cycle Frances Zipp, President & CEO, Lachman Consultant Services, USA
0945 KEYNOTE: Current Expectations and Guidance, including Data Integrity and Compliance with cGMPs Ian Thrussell, former WHO GMP & UK MHRA Expert Inspector, Switzerland
1030 Morning refreshments  
1100 KEYNOTE: Data Integrity, the Challenges to Meeting Regulatory Requirements  
1145 Panel discussion: Challenges to Data Integrity in Emerging Markets Moderator: Tony Margetts, Compliance Manager, Factorytalk, Thailand & Speakers

Industry Best Practices

1330 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
1415 Quick Wins for Data Integrity Compliance: GAP Assessment  Christopher Reid, CEO, Integrity Solutions Limited, UK
1500 Afternoon refreshments  
1530 Application Workshop: Risk-based Approach to Records and Data Integrity Charlie Wakeham, Informatics CSV Consultant, Waters Asia; ISPE GAMP, Australia
1615 Quick Wins for Data Integrity Compliance: Audit Trail Valeria Frigerio-Regazzoni, Senior Director, Head of Quality Auditors & Consultants Group - ‎Merck Group, Switzerland
1700 Panel Discussion / Q&A Speakers
1730 End of Day 1  
1800 Evening Socials (optional)  

 

 Tuesday 14 November

Data Integrity & Enabling Technologies

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, USA
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 Speakers & 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
1400 Case Study: Data Integrity in the Clinical Environment  
1445 Case Study: Addressing Company Data Integrity Challenges Guy Wingate, VP & GMS Compliance Officer, GlaxoSmithKline, UK
1530 Afternoon refreshments  
1600 The Quality Culture in Implementing a Corporate Data Integrity Programme

 

1630 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 & Pierre Winnepenninckx, CEO, No deviation, Singapore
1715 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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