Process Validation with Qualification: 2-Day Online Training Course (May 21-22, 2024) - Fully Understand and Comply with Current EU and FDA Process Validation Guidelines

Dublin, Jan. 31, 2024 (GLOBE NEWSWIRE) -- The "Process Validation with Qualification Training Course" conference has been added to's offering.

Attending this invaluable two-day event will give you the tools to fully understand and comply with current EU and FDA process validation guidelines and meet implementation challenges.

Taking a practical and analytical approach to process design, equipment and utility qualification, the programme will link product requirements to equipment verification and commercial-scale process validation.

Good engineering practice (GEP) and a range of techniques, including quality risk management and design of experiments
and statistics, will be examined to optimise continual improvement in process qualification, verification, commissioning and validation.

Benefits of attending:

  • Know the scope of FDA, EU and other international validation guidelines
  • Establish a three-stage, science and risk-based, life cycle process validation programme that can be applied to all products internationally, from generic products to novel medicines to ATMPs
  • Clarify similarities and differences between EU and US regulatory expectations
  • Understand the importance of a science and risk-based approach to support process validation and qualification
  • Realise significant business benefits by clarifying the key purposes of validation
  • Reduce validation documentation by concentrating on product drivers supported by clear qualification steps
  • Unscramble the real meaning of buzzwords such as qualification, verification and validation
  • Learn tools and techniques for you to subsequently apply to your products


  • CPD: 12 hours for your records
  • Certificate of completion

Who Should Attend?

This seminar will be of particular interest to all those from the pharmaceutical industry working in:

  • Development
  • Manufacturing
  • Engineering
  • Quality

It will also benefit the following personnel working in the pharmaceutical and biopharmaceutical industry:

  • 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

Key Topics Covered

Day 1

  • The science and risk-based approach to process validation
  • ICH Q8/9/10/11/12
  • Exercise 1 - Key points
  • Introduction to the FDA process validation guidance
  • Introduction to the EU Process Validation Guidelines and Annex 15
  • Exercise 2: Guidance
  • Process design: FDA PV Stage 1
  • Exercise 3: Process Design
  • Quality risk management
  • Exercise 4: Risk assessment

Day 2

  • Equipment and utility qualification: FDA PV Stage 2.1
  • Exercise 5: Equipment Qualification
  • Tools for Process Validation - part 1
  • Tools for Process Validation - part 2
  • Exercise 6: What techniques/tools to use at which PV Stage
  • Process Performance Qualification/Process Validation - FDA PV Stage 2.2
  • Exercise 7: Process Validation - number of batches
  • Continued Process Verification/Ongoing Process Verification - FDA PV Stage 3
  • Exercise 8: Ongoing Process Verification
  • Case Study: Process improvement
  • Exercise 9: Continual Improvement
  • Exercise 10: SWOT

For more information about this conference visit

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