GOOD ENGINEERING PRACTICE: (GEP)

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 Attrend:

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