About This Workshop

This workshop provides an introduction to validation training and the fundamental requirements of medicinal product validation. Pharmaceutical validation has been a regulatory requirement for nearly 40 years and continues to attract significant regulatory attention. As well as the obvious benefits of compliance, validation also offers significant business advantages because well understood, capable and controlled processes form the basis of day-to-day manufacturing and testing operations.

Our validation training course provides a concise, pragmatic introduction to the validation lifecycle. It covers analytical, facilities, utilities, equipment qualification, computer systems, process validation and cleaning validation.

You get an overview of how you can apply these concepts to your own activities and assess your own process vulnerabilities.

Using examples and applications from across the industry, you learn the correct approach while also formulating your own compliance plans to take forward.

Key Learning Objectives

By the end of this workshop you will:

  • Have knowledge of the current regulatory expectations relating to:
    • Analytical
    • Facilities, utilities and equipment
    • Computer systems
    • Process validation
    • Cleaning validation
  • Understand how International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) principles and the three stages of the process validation lifecycle come together
  • Understand how the individual elements are prerequisites to successful process validation
  • Understand validation documentation requirements
  • Assess organizational requirements to deliver validation
  • Have knowledge of validation maintenance requirements

Who Should Attend

This validation training course is an ideal introduction to validation for managers, supervisors and operators who are new to the subject and are directly involved or responsible for validation or verification, setting or assessing compliance and an overall validation strategy.

Course Tutor

Richard Kettlewell - Richard has over 30 years of experience in the pharmaceutical manufacturing sector. He has supported and inspected many sites of varied dosage forms worldwide. Richard has a master’s degree in pharmaceutical sciences and joined the industry in 1986 at GlaxoSmithKline, where he spent 32 years in QC, QA and technical roles. He developed and implemented lifecycle approaches to process validation across R&D and manufacturing organizations and supported new products introductions for both API and secondary filing.