29th September 2008

Time:  9:00-16:00

Pathumwan Princess Hotel, Bangkok, Thailand

Reaching US FDA GMP standards with Information Technology: Highlighting how modern Information Systems can ensure that procedures and processes used in Pharmaceutical manufacturing are compliant to GMP standards (US FDA). Areas to be covered include management of equipment, batch record execution, manufacturing recipe and production process control.

Agenda

09:00 - Start

• Achieving GMP requirements with IT systems - T. Cheepchol

Coffee Break

• ERP key Essentials in Pharmaceutical Industry - W. Wirayagorn

Lunch

• Computer Systems Validation (CSV): Session 1 - T. Margetts

- Introduction to CSV

- GAMP 5: CSV guidance updated

Coffee Break

• Computer Systems Validation (CSV): Session 2 - T. Margetts

- Practical Computer Systems Validation

- Case study examples

• Summary

16:00 - Close

Seminar Speakers

Mr. Teerapong Cheepchol, Senior Consultant, Factorytalk Co., Ltd.
Dr. Tony Margetts, Good Automated Manufacturing Practice editor
Mr. Wisit  Wirayagorn, Managing Director, ISS Consulting (Thailand) Ltd.

Workshop Feedback

Reaching US FDA GMP standards with Information Technology is a highly attractive event. This event has attended by 50 paticipants from 18 leading pharmacuetical industries and universities in Thailand.