Introduction to validation

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.

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

    Jane Wright

    Jane has over 30-years’ experience in quality assurance roles, including Quality Management positions and, encompassing a wide range of dosage forms. Dosage form experience includes metered dose inhalers, tablets, capsules, liquids, topical preparations, plus sterile products.

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