Quality Guidelines ask almost all to carry out risk management, particularly directives and legislation from governments such as demand by ICH Q9. In this training we will discuss what is Risk Management and how Risk Management can be applied within the different sub-areas of your organization.

The following topics are covered:

• Policies and legislation, EU and FDA
  • ICH Q9
  • ISO 31000, ISO / IEC 31010
  • ISO 14971
• General risk management
• Failure Mode and Effect Analysis (FMEA) technique
• Application of risk management techniques within
  • Change Management
  • Exceptions Management
  • Supplier management
  • Qualification and Validation Management
• Different workshops in relation to practical Risk Management

Who should attend this training

This training is specifically designed for Validation, Quality Assurance, Engineers, ICT, Project Managers, Process Engineers and others who are interested in Risk Management techniques.

If non-Dutch students participate, the training will be given in English language.

General information

• The student will receive two weeks training for an email training and location details
• The student will receive a certificate after the training
• Lunch and refreshments during the training included
• The student receives at the beginning of the training a binder which includes the printed slides of the presentation.

Trainers

• Tim Mojet
• Marcel Schakel

Price

• € 795,00 per student (excluding VAT)

Registration

You can register for this training using the tab 'Training schedule'.

For information please contact Marcel Schakel, phone +31 (0) 6 49022609 or email This email address is being protected from spambots. You need JavaScript enabled to view it.