GXP
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GOOD ENGINEERING
PRACTICE:
(GEP)
Conference Date: 21 Apr 2010-05 Jun 2010
Conference Ref: M4-6010
Fee: £1260 + VAT
Venue: The Rembrandt Hotel, London
This seminar will focus on the following:
- ISPE Good Engineering Practice Guide
- Applicable Regulations
- Risk Management
- Practical application of science and risk based approach to process and system equipment verification
- Making best use of supplier documentation
- Understanding of terminology and the ‘busting’ of some myths
- Practical approach to documentation and document approvals
- Change management and how to gain acceptance of this
- Auditing
- Maintenance management
- Opportunity to take part in group exercises to use tools in real life examples
Who Should Attend:
Professionals in:
- Quality Assurance
- Operations Management
- Engineering Management
And those involved in:
- Engineering Projects, Operations and Management
- Quality Assurance and Auditing
Those checking:
- Validation Documentation
- All aspects of Validation, Qualification, Verification and any other regulated background
At the end of this seminar, participants will be able to:
- Balance expenditure and activity in relation to cost and benefits
- State a clear definition of good engineering practice
- Understand how the risk based approach will improve effectiveness and reduce costs
- Have a common understanding of the concept and principles of GEP
- Explain how GEP concepts may be applied in the healthcare industry
- Balance expenditure and activity against the associated risks and benefits of a defined scope of work
Speakers:
Mark Foss Head of Engineering, Boehringer Ingelheim, UK
John Andrews Director, Andrews Consulting Enterprise Ltd., UK

