Project & Quality Training International

Process Validation

Within the Life Science Industry (Pharmaceutical, Medical Devices, Biotechnology, etc.) but also increasingly the Food Industry, Process Validation is an essential part of the Quality System, where strict requirements of guidelines and legislation must be met, such as those from the FDA and European GMP. In this training we deal with what Process Validation content, what requirements are set and how Process Validation can be applied within your organization.

The following topics are covered in the training:

  • Guidelines; EU and FDA
    • EU GMP Annex 15
    • FDA Guidance for Process Validation
    • EMA Guideline on process validation
  • Process Development
  • Process Qualification
  • Proces Validation
  • Continuous process verification / re-validation
  • Using Risk Management, as Process Failure Mode and Effect Analysis (PFMEA)
  • Validation Master Plan
  • Practical examples of Process Validation:
    • Qualification of process equipment
    • Performance Qualification protocol and repport
    • Risk based testing
    • Qualification and Validation Management
 

Who should attend this training

This training is specially designed for qualification/validation staff, Quality Assurance staff, Process Engineers and others who interested in Process Validation in general.

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

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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

Price

  • € 750,00 per student (excluding VAT)

Registration

You can register for this training using our 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.