Process Validation for Pharmaceuticals

In-house Training and Consultancy Services

The two-day In-house programme will focus on balancing Science and Risk during the Product Lifecycle. This will help your team gain an understanding of the EU and FDA Process Validation Guidance and 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.

Sample programme

• The science and risk-based approach to process validation
• ICH Q8/9/10/11
• Introduction to the FDA Process Validation Guidance
• Introduction to the EU Process Validation Guideline and Draft Annex 15
• Exercise one: Guidelines
• Process design: FDA Stage 1/EU Pharmaceutical Development
• Exercise two: Process design
• Equipment and utility qualification: FDA Stage 2.1 / EU Annex 15
• Exercise three: Equipment qualification
• Process performance qualification/process validation: FDA Stage 2.2/ EU approaches
• Quality risk management
• Exercise four: Process validation
• Continued process verification/ongoing process verification: FDA Stage 3/EU Annex 15
• Exercise five: Ongoing process verification
• Continual improvement and process optimisation
• Exercise six: Continual improvement
• Case study: Process improvement
• Discussion: Implementation challenges
• Case study: Continued/ongoing process verification

Recommended trainers

Bruce 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. Bruce 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.

Line Lundsberg is a Global Technology Partner in GMP and Regulatory aspects, working for NNE. She has been working in the pharmaceutical Industry, both in pharmaceutical development and product manufacturing for the last 20 years. Her background is in physics and she holds a PhD in Process Analytical Technology.
Line’s main consulting areas are Regulatory Expectations, future pharma trends in smart manufacturing & control, Quality by Design (QbD), Process Analytical Technology including Real Time Release Testing, Process Validation, and Good Manufacturing Principles combined with science and risk based innovative development and manufacturing.
Line was one of the pioneers that together with the FDA, EMA and the ASTM standard organisation, took part in developing the Science and Risk based framework that today is the new foundation for product development and manufacturing in the pharmaceutical and biotech industry. She is active in ISPE, a global trainer in QbD and Process Validation and a well-recognised speaker at international conferences and events.