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.
Speaker Qualifications
Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.
Programme Changes
Programme is subject to change. Last minute changes due to functional, private, or organisational needs may be necessary. The event organiser accepts no liability for any additional costs caused by a change of programme.
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