RISK MANAGEMENT AND
RISK ANALYSIS - A
Core Compliance
Process

Conference Date: 13 Oct 2010
Conference Ref: TD N10-8210
Fee: £450 + VAT
Venue: MWB Cavendish Square, London, W1

This course forms part of the new Medical Device Training Academy series: Medical Device Training days, therefore when you download the brochure details of this course together with others in the same series will be provided.

Course Summary

The risk management process is the backbone of the European Regulation. As such, its effective implementation is key to the success of the manufacturer in complying with the requirements.

The purpose of this training day is to present the background of risk management in the framework of the relevant harmonised standards. Through practical examples the process is rolled out, and its impact on the organisation and its documentary system is explained. The course is interactive and will involve the trainees in completing case studies.

Key Topics to Include:

• ISO 14971 and its Background
• Sequence of the Process and Their Importance
• Risk Mitigation
• How to Conduct a Risk Analysis
• Connection to the Technical File
• Specifics to Active and Passive Medical Devices

Who Should Attend:

• All those who need to comply with the Directives and Quality Systems in their role within the organisation:
• Project Managers
• Regulatory Affairs Managers
• Quality Assurance Professionals
• Operations Managers
• Safety and Risk Analysis
• Sales and Marketing Managers

Tutor:
Will Burton, Director, RSQA

Please contact andrea.james@management-forum.co.ukif you wish to know more about the new Training Academy or click here to visit our Training Academy Blog.

Click here to register for this important Seminar.