Process Validation with Qualification

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