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EU and FDA Process Validation Guidance Course (London, United Kingdom - March 3-4, 2020) -


The "Process Validation with Qualification" conference has been added to's offering.

Gain a comprehensive understanding of the EU and FDA Process Validation Guidance, how to establish a Process Validation Programme, understand the link between quality by design and process validation, apply relevant tools for process validation including risk assessment

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 of 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
  • Understand how Quality by Design supports process validation
  • Realise significant business benefits from taking a science and risk-based approach

Who Should Attend:

This seminar will be of particular interest to all those from the Pharmaceutical Industry working in:

  • Development
  • Manufacturing
  • Engineering
  • Quality

Personnel from the pharmaceutical and biopharmaceutical industry with the following background:

  • Process engineers
  • Pharmacists
  • Scientists
  • Quality assurance professionals
  • Quality control managers
  • Late-stage product and process development engineers, scientists, pharmacists
  • Technology scale-up and transfer managers
  • Validation and qualification managers
  • Validation and qualification specialists
  • Risk management specialists
  • Lean management specialists
  • Operations managers and engineers


Programme - Day one

  • The Science and Risk-Based Approach to Process Validation
  • ICH Q8/9/10/11
  • Introduction to the FDA Process Validation Guidance
  • Introduction to the EU Process Validation Guideline and Draft Annex 15
  • Discussion
  • Exercise 1: Guidelines
  • Process Design: FDA Stage 1/EU Pharmaceutical Development
  • Exercise 2: Process Design
  • Equipment & Utility Qualification: FDA Stage 2.1/EU Annex 15
  • Exercise 3: Equipment Qualification
  • Feedback and Discussion
  • Process Performance Qualification/Process Validation: FDA Stage 2.2/EU approaches

Programme - Day Two

  • Introduction to Day Two
  • Quality Risk Management
  • Exercise 4: Process Validation
  • Continued Process Validation/Ongoing Process Verification: FDA Stage 3/EU Annex 15
  • Exercise 5: Ongoing Process Verification
  • Continual Improvement and Process Optimisation
  • Exercise 6: Continual Improvement
  • Feedback and Discussion
  • Case Study: Process Improvement
  • Discussion: Implementation Challenges
  • Case Study: Continued/Ongoing Process Verification
  • Feedback and Discussion

For more information about this conference visit

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