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Event Details


Process Validation in the US and EU

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Who should attend?

This seminar will be of particular inveterst 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, Engineers



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:

  • Understand the link from product requirements, to equipment verification and process validation
  • Clarify the similarities and differences between process validation expectations in the EU and US
  • Establish a Process Validation programme
  • Understand the link between Quality by Design and Process Validation
  • Gain a practical, science and risk-based approach to Process Validation including Equipment Verification
  • Apply relevant tools for Process Validation, such as Risk Assessments, Design of Experiments and Statistics
  • Gain knowledge in Good Engineering Practice (GEP)
  • Unscramble the real meaning of ‘buzz words’ such as Qualification, Verification, Commissioning, Validation etc.
  • Realise significant business benefits from a science and risk-based approach




Leigh White

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