Track 3: Information Technology

Monday 14 November - Tuesday 15 November 2011

Should Pharma be Afraid of the Future Vision of IT? 
How Should Corporate Strategies for Cloud Computing, Virtualisation and Outsourcing be Affected by Compliance Concerns?
Many companies are not sure what the regulatory impact of hot new technologies may be, and as a result sometimes find that they have wasted time and money on ineffective initiatives.
Attending this session will help you understand the implications such new technologies have, and you’ll see approaches that can help you to better manage your data. Join Regulators and Industry experts during round table discussions on virtualisation, cloud computing and outsourcing.

Leaders:
Randy Perez
, PhD, Director of IT Risk Management and Compliance, Novartis Pharmaceuticals Corp. (USA)

Speakers:
Christopher Evans
, GSK (UK) (TBC)
Sam Brooks, Novartis (UK) (TBC)
Keith Williams, CEO, GxPi (UK)
 

At the conclusion of this session, participants will be able to:
Leverage state-of-the-art technical and business strategies for information systems while maintaining a state of control and compliance.

Who Should Attend?
IT Quality, Compliance Professionals, GAMP® COP.

Download the Registration Form for this Conference here! ( 42 KB)

Latest Agenda:

Monday 14 November 2011
9:30 10:30 Keynote Address
10:30 10:50 Refreshment Break
10:50 12:30 Keynote Address
12:30 13:30 Lunch and Networking Break
13:30 14:00 Welcome and Introduction to IT Track Session
Randy Perez, Novartis (USA); Robert Tollefsen, FDA (USA)
14:00 15:00 Risk Management for Outsourcing/Offshoring
Christopher Evans, GSK (UK)
15:00 15:30 Networking Break
15:30 16:30 Virtualisation in the Regulated Environment
Randy Perez, Novartis (USA)
16:30 16:45 Session Wrap-up
Randy Perez, Novartis (USA); Robert Tollefsen, FDA (USA)
16:45   Session Adjourns
Tuesday 15 November 2011
8:00 8:10 Welcome and Agenda Review
Randy Perez, Novartis (USA); Robert Tollefsen, FDA (USA)
8:10 9:10 Regulated Applications in the Cloud
Keith Williams, GxPi (UK)
9:10 10:00 The Cloud as a Disaster Recovery Solution
Sam Brooks, Novartis (UK)
10:00 10:30 Networking Break
10:30 12:00 Roundtable Discussions on Virtualisation, Cloud DR Solutions, Cloud Security and Outsourcing
Randy Perez, Novartis (USA); Robert Tollefsen, FDA (USA); Christopher Evans, GSK (UK)
12:00 13:00 Lunch and Networking Break
13:00 13:30 Roundtable Discussion - Continue
Randy Perez, Novartis (USA); Robert Tollefsen, FDA (USA); Christopher Evans, GSK (UK)
13:30 14:20 Report back from Roundtable Discussions
Randy Perez, Novartis (USA); Robert Tollefsen, FDA (USA)
14:20 14:30 Session Adjourns
14:30 15:00 Networking Break
15:00 17:00 ISPE GAMP Conference - Plenary Session

Conference Highlights:

Monday 14 November - Tuesday 15 November 2011

In honour of our 20th Anniversary of GAMP®, ISPE is offering 20% off all GAMP®Guidance Documents in the Guide Series to ISPE Members*.

*Guidance Documents will not be on site. You will be able to complete the order form and ISPE will ship your order to you. If you cancel registration to the conference after purchasing any GAMP Guide(s) you will be charged the full Guidance Document price. 20% discount applies to ISPE Members only.