Data Integrity from Concept to Practice
ISPE 2017 Asia Pacific GAMP® Data Integrity Conference
In a two year period from 2010 to 2012, only five pharmaceutical manufacturers were cited for data integrity violations. In 2016, 26 warning letters were issued of which manufacturers in Asia are starting to make up a great number.
Although not a new issue, focus has shifted to Data Integrity due to numerous recent Health Authority enforcement actions such as:
- Warning Letters
- Import Alerts
- Product Detentions
- Suspension or revocation of Marketing Authorizations
Data Integrity can result from lack of awareness, employee errors, failure to check accuracy of data, software or system malfunction, configuration problems with electronic data handling, or misconduct by employees.
The opportunity for open dialogue between the pharmaceutical industry and regulatory agencies is rare. But when given the forum to openly discuss issues of mutual concern, exciting solutions can emerge that capture the essence of our common goal: safe and effective medicines for patients.
The inaugural ISPE 2017 Asia Pacific GAMP® Data Integrity Conference enables all stakeholders to review their data management across the product lifecycle. This event is designed to be practical and interactive, comprising expert presentations where you will apply to ‘live’ case studies, related to your own jobs.
This conference promises a unique opportunity for interaction between you, the pharmaceutical industry, and regulatory agencies for ongoing dialogue to allow for improved alignment of industry best practices. You will be able to refine your organizations’ data integrity framework to meet the needs of regulatory requirements and current best practices.
By attending the ISPE 2017 Asia Pacific GAMP® Data Integrity Conference you will:
- Gain insight into the latest requirements and practices to enable robust data management and data integrity across the product life cycle
- Understand the key challenges and possible hurdles in data integrity, with practical tips and solutions to tackle them
- Discover the latest tools and technologies available to improve your current practices
- Gauge the alignment of your organizations’ priorities with those of other manufacturers, suppliers, and regulatory agencies
- Provide feedback to the pharmaceutical industry on data integrity challenges and issues you're facing today
Global and Regional Case Studies and Experts:
- Geoff Brown, President, ISPE Singapore
- Frances Zipp, President & CEO, Lachman Consultant Services, USA
- Karen Takahashi, Senior Policy Advisor, US FDA CDER OPQ
- Ian Thrussell, former WHO GMP & UK MHRA Expert Inspector, Switzerland
- Tony Margetts, Compliance Manager, Factorytalk, Thailand
- 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
- Christopher Reid, CEO, Integrity Solutions Limited, UK
- Charlie Wakeham, Informatics CSV Consultant, Waters Asia; ISPE GAMP, Australia
- Edit Szöcs, Auditor & Consultant, Merck Biopharma, Switzerland
- Georg Singewald, Head Quality, Solids & Special Technologies, Novartis Pharmaceuticals Asia Pacific, Singapore
- Jason N. Young, Principal Cyber Security Architect, Silver Bullet Security, Australia
- Dave Abramowitz, Director for Compliance, Software and Professional Services, SCIEX
- Lim Fu Chin, Halfmann Goetsch Partner, Singapore
- Emily Tan, Corporate Vice President, Portfolio Leadership, Parexel, Singapore
- David Margetts, Managing Director, Werum IT Solutions, Thailand
- Guy Wingate, VP & GMS Compliance Officer, GlaxoSmithKline, UK
- Willy Susanto, Senior Data Integrity & CSV Engineer, Abbvie Singapore
- Pierre Winnepenninckx, CEO, No deviation Singapore