Two Day Course on Process Validation (London, United Kingdom - March 3-4, 2020)

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Oct 10, 2019, 10:30 ET

DUBLIN, Oct. 10, 2019 /PRNewswire/ -- The "Process Validation with Qualification" conference has been added to ResearchAndMarkets.com's offering.

This two-day process validation course looks at balancing science and risk during the product lifecycle meeting and will help you gain an understanding of the EU and FDA process validation guidance. You will 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.

Benefits of attending:

Know the scope of the FDA and EU validation guidelines
Establish a three-stage, science and risk-based, lifecycle process validation programme
Clarify similarities and differences between EU and US expectations
Understand how Quality by Design supports process validation
Realise significant business benefits from taking a science and risk-based approach

Who Should Attend:

Personnel from the pharmaceutical and biopharmaceutical industry with the following background:

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

Agenda:

Programme - Day one

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
Discussion
Exercise 1: Guidelines
Process Design: FDA Stage 1/EU Pharmaceutical Development
Exercise 2: Process Design
Equipment & Utility Qualification: FDA Stage 2.1/EU Annex 15
Exercise 3: Equipment Qualification
Feedback and Discussion
Process Performance Qualification/Process Validation: FDA Stage 2.2/EU approaches

Programme - Day Two

Introduction to Day Two
Quality Risk Management
Exercise 4: Process Validation
Continued Process Validation/Ongoing Process Verification: FDA Stage 3/EU Annex 15
Exercise 5: Ongoing Process Verification
Continual Improvement and Process Optimisation
Exercise 6: Continual Improvement
Feedback and Discussion
Case Study: Process Improvement
Discussion: Implementation Challenges
Case Study: Continued/Ongoing Process Verification
Feedback and Discussion

Speakers:

Bruce Davis, NSF Healthsciences

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.

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.

For more information about this conference visit https://www.researchandmarkets.com/r/a649v5

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