Process validation & qualification, including validation methods

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 has worked in the pharmaceutical industry for over 25 years, including roles within AstraZeneca spanning International Engineering of Facilities, facilitation of Quality by Design, capital and asset programmes and strategy. He has been responsible for training regulators and is a past Chairman of ISPE.

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