21th August 2009

Time:  9:00-16:30

Ambassador Hotel, Bangkok, Thailand

Later this year the European Union will publish new guidance on the use of computerised systems for the manufacture of medicinal products: European Union Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Draft Annex 11 Computerised Systems.

The updated Annex11 of the EU GMP will also be the PIC/S standard. Companies currently supplying to or intending to supply PIC/S markets or the EU should be aware of and determine their approach in meeting the regulations. Responsible staff from Companies' Production and QA departments should understand the benefits these regulations can bring and IT departments will need to review and align their procedures and processes.

Agenda

- Outline of the new annex

- Applicability in Thailand

- The effect on Production and QA

- The effect on IT

- Recommended Company Activities

- Information on Validation Planning & Risk Assessment

- Role of Regulated Company and Role of Supplier

- Regulated company activities, Supplier Activities

The event will include several workshop sessions to help understanding. The sessions will be interactive and will also discuss practical case studies. The speaker welcomes questions throughout and as preferred questions maybe submitted prior to the event using the attached form.

Seminar Speaker (The presentation will be in English)

Dr. Anthony Margetts, Good Automated Manufacturing Practice editor

Workshop Feedback

PIC/S Update: EU GMP Guidelines on Medicinal Products for Human and Veterinary Use - Draft Annex 11 Computerised Systems attended by 43 paticipants from 19 leading pharmacurtical companies in Thailand. According to the chart above, almost half of the participants found that the workshop is better that expected and noone thought that it is dissappointed.