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06-Mar-2019 - 07-Mar-2019

Process Validation in the US and EU

  • Location:
    • Venue to be confirmed

Course Overview

The two-day process validation in the US and EU, balancing science and risk during the product lifecycle meeting will help you gain an understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, under the link between Quality by Design and process validation as well as how to apply relevant tools for process validation including risk assessment.

Benefits in attending:

  • Know the scope of the FDA and EU validation guidelines
  • Establish a three stage, science-and-risk-based, lifecycle process validation programme
  • Clarify similarities and differences between EU and US expectations, with consideration of differing company requirements eg innovative to generic manufacturers
  • Understand how Quality by Design supports process validation
  • Link product requirements, to equipment verification to commercial scale process validation
  • Gain knowledge in qualification including Good Engineering Practice (GEP)
  • Apply tools such as Quality Risk Management, Design of Experiments and Statistics
  • Unscramble the real meaning of ‘buzz words’ such as qualification, verification, commissioning, calidation etc.
  • Realise significant business benefits from taking a science and risk-based approach