Introduction to Validation

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1 Day/s

CPD Hours: 7

Online, in-house

The course provides an overview of the concept of qualification and validation as described in Annex 15 to Eudralex Volume 4.


It covers responsibilities and terminology (qualification, validation and verification), and looks at the requirements of equipment qualification (IQ, OQ and PQ), process and cleaning validation, analytical method validation. The need for effective change management and lifecycle management will be discussed. The course also examines the documentation and project management aspects of validation studies.


Classroom courses - please note, the advertised venue may need to be changed, if the required number of delegates is not met. In this situation, the course will be converted to an Online Virtual course and all delegates notified accordingly. The decision regarding the venue will be made at least 4 weeks before the course is due to run.


This course will be of value to all pharmaceutical professionals, including management, laboratory and manufacturing staff, and engineering personnel, who need to understand the current GMP expectations of validation in today’s regulatory environment.

This course includes the following topics:


  • Basics of validation
  • Planning validation
  • Documentation
  • Protocol preparation
  • Qualification protocols and reports
  • Protocol Completion analytical
  • Method validation process and cleaning validation
  • Transport, packaging and utilities

      • By the end of the course you will:


      • Understand the regulatory expectations
      • Know how to evaluate validation and qualification requirements
      • Be able to plan and document validation studies
      • Understand the link to change management and ongoing lifecycle management
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    Meet the tutors

    John Spenn

    John Spenn is an experienced quality professional with over 25 years in the biopharmaceutical / life sciences industry. John has held senior strategic management and leadership roles and has extensive knowledge and experience in quality management and regulatory processes as well as CQV lifecycle for equipment, facilities, utilities, computer systems, sterilisation and cleaning validation. John is currently a director at Dorset Quality Services offering validation and quality consultancy services to the pharmaceutical and life sciences industry. His previous positions include Associate Director and Head of Validation at Lonza Biologics, Cleaning and Process Validation Manager at Porton Biopharma and Validation Manager at Public Health England.

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