Process Validation and Qualification, Including Validation Methods

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2 Day/s

CPD Hours: 14

Classroom, in-house

This course provides candidates with practical tools for validation including, qualification, process validation and analytical method validation. Incorporating facility/equipment qualification, process validation and validation of analytical methods for requirements in Europe, US and elsewhere, including ICH.


This course is suitable for those working in most pharmaceutical companies e.g. those producing novel medicines, generics manufacturers, ‘virtual’ companies, suppliers/contract manufacturers, etc. It is applicable to scientists, engineers, validation professionals working in development, manufacturing, quality, support functions, engineering, validation and other related departments.


The course covers facility/equipment qualification, process validation and validation of analytical methods. It covers regulatory guidance and requirements for Europe, US and elsewhere, including ICH.

This course is suitable for those working in most pharmaceutical companies e.g' those producing novel medicines, generics manufacturers, ‘virtual’ companies, suppliers/contract manufacturers, etc. It is applicable to scientists, engineers, validation professionals working in development, manufacturing, quality, support functions, engineering, validation and other related departments.

During the two days the course will cover the following aspects:


  • Why validate?
  • International regulatory requirements, e.g. US, EU & elsewhere
  • Science and risk -based approaches
  • The 3 stages of the validation life-cycle (Ref FDA & EU)
  • Tools to enable effective validation such as:
    • Understanding product and manufacturing process requirements
    • Importance of Control Strategy
    • Application of Quality Risk Management
  • Readiness
  • Process validation
  • Determining the number of validation batches
  • Qualification of equipment and utilities
  • Maintaining control of product life-cycle, including monitoring 
  • Analytical validation:
    • ICH Q2 principles
    • Analytical method validation

    By the end of this course, you will:


    • Understand regulatory requirements in EU, US and internationally for process validation, qualification & analytical methods
    • Understand the 3 Stage approach to validation and its applicability internationally
    • Apply tools and techniques to help clarify validation deliverables
    • Appreciate the importance of science and risk-based approaches to validation and alignment to ICH Q8, Q9 and Q10

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Meet the tutors

Bruce Davis

Bruce Davis carries out training and consultancy in a number of science and risk-based topic areassuch as Quality Risk Management (QRM); Quality by Design (QbD); Process validation/ qualification; Technology transfer. He is an experienced trainer with many years’ experience of the pharmaceutical industry. He tries to ensure participants have an engaging and learning training experience. He has always been interested in the importance of having a patient and science and risk-based approach and in its application during training. He runs his own consultancy business and has done for the past 11 years. He formerly worked at AstraZeneca, where he had an international engineering role, being responsible for putting in place new manufacturing and development facilities. He is past chair of ISPE and has contributed to or colead a number of their industry guides, including Technology Transfer, Process Validation, and a chapter on ATMPs.

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