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.
In today's pharmaceutical and biopharmaceutical industries, ensuring the reliability and efficiency of manufacturing processes is paramount. The need for rigorous process design, equipment qualification, and validation extends beyond mere compliance; it directly impacts product quality, patient safety, and regulatory adherence.
This comprehensive programme addresses these critical needs by taking a practical and analytical approach to process design, equipment, and utility qualification. It bridges the gap between product specifications and the meticulous verification required for equipment and processes at commercial scale.
Participants will delve into the foundational principles of Good Engineering Practice (GEP), essential for maintaining consistency and reliability throughout the manufacturing lifecycle. The course explores a range of advanced techniques, including Quality Risk Management (QRM), Design of Experiments (DoE), and statistical analysis. These methodologies are pivotal in optimising process qualification, verification, commissioning, and validation to achieve continual improvement and regulatory compliance.
Through expert guidance, attendees will learn how to apply these principles effectively, ensuring robust process design and validation strategies aligned with industry standards and best practices.
Upcoming start dates
Suitability - Who should attend?
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
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Reviews by course attendees
Average rating 4.3
The course was very informative and the speaker explained the content very well. I've also liked that all relevant guidelines have been included in the slides.
Very pleased with the course, it was thorough and there was plenty of time for discussion and questions.
Coming from a medical device background there was a lot of cross over...
About IPI Academy
International Professional & Industry Academy (IPI) is an international leading professional training organisation based in London. Our training solutions provide a return on your investment with measurable results, and are delivered by experienced professionals and managed with exceptional care and...
The course was very informative and the speaker explained the content very well.