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.
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
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Speakers
Mr Bruce Davis,
Associate ,
NSF HealthsciencesBruce Davis runs his own training/consultancy company for science and risk based approaches to Engineering and Process Validation (PV), Quality by Design (QbD), Quality Risk Management, GMP for Engineers and other related topics. He has run many training events for companies both in the UK and internationally and is often invited to speak at international conferences.
He is past Chair of ISPE International Board of Directors and led their case study for practical implementation of QbD. He co-chaired the team updating their Technology Transfer (TT) Guide and carries out training for them and other organisations.
He is a professional engineer and has many years’ experience in the pharmaceutical industry and a wide international knowledge, and understanding of current regulatory approaches in the above topics for both US and EU.
He previously worked at AstraZeneca, where he had a number of responsibilities, including managing international engineering, facilitating QbD and leading changes to qualification practices.
He played a leadership role to set up De Montfort University’s MSc distance learning course in QbD.
He is an Associate to NSF Healthsciences, and for them has carried out consultancy and training in the above topic areas, and also for driving down human error.
Who Should Attend
Professionals working in development, manufacturing, engineering and quality within the pharmaceutical and biopharmaceutical industry, including:
- 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
