ISPE Thailand Annual Meeting 2012 “Good Engineering Practice (GEP)”

26-27 July 2012

Arnoma Hotel, Bangkok, Thailand

“Good engineering practice” or “GEP” is a term applied to engineering and technical activities to ensure that a company manufactures products of the required quality as expected by the relevant regulatory authorities. Good engineering practices are to ensure that the engineering or software development methodology generates deliverables that support the requirements for qualification or validation. Good engineering practices are applied to all industries that require engineering; they do not solely apply to the pharmaceutical industry.

Background and Objective:

The use of “Good engineering practice” is good practice for managing pharmaceutical industry projects and will reduce time and resources spent on qualification and validation.

This event will be two day seminar which will be focused on following:

• Applicable Regulations
• Risk Management
• Practical application of science and risk based approach to process and system equipment verification
• Making best use of supplier documentation
• Practical approach to documentation and document approvals
• Change management and how to gain acceptance of this
• Opportunity to take part in group exercises to use tools in real life examples

Who should attend

Pharmaceutical Industry Managers and Professionals, QA, Production, Engineering and Supplier Companies

AGENDA

* Sessions are conducted in English and translated by Mr. Totsapon Santitewagun and Ms. Jittaporn Wattanaseree.