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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

DAY 1 – Thursday 26 July 2012

 

DAY 2 – Friday 27 July 2012

09.00

Welcome

 

09.00

Welcome

09.20

Why GEP?
Presented By Ms. Sanhaluck Buasuang

 

09.05

Factory Planning and Risk Management *
Presented By Mr. Alain Kupferman

10.00

Good Engineering Practices Principle*
Presented By Dr. Anthony Margetts

 

10.40

Coffee Break

10.40

Coffee Break

 

11.00

Factory Planning and Risk Management *
Presented By Mr. Alain Kupferman

11.00

URS*
Presented By Dr. Anthony Margetts

 

12.00

Lunch

12.00

Lunch

 

13.00

ISPE Thailand Summary
Presented By Ms. Sorada  Wangmethekul, ISPE Thailand President

13.00

  • Design Review  *
  • Change Control *

Presented By Dr. Anthony Margetts

 

13.30

  • Project Execution plan
  • Project Quality Management
    Presented By Ms. Jittaporn Wattanaseree

15.00

Coffee Break

 

14.30

Coffee Break

15.20

Document Management
Presented  By Ms. Chompunut Apinan

 

14.50

  • GMP Assessment & Risk Analysis *
  • Case study of GEP + Validation *
    Presented By Dr. Anthony Margetts

16.30

Closure

 

16.30

Lucky Draw & Closure

 

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

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