Course Overview

This introduction to validation pharmaceutical training workshop will provide you with an introduction to the scope and 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 with regulatory expectations, validation also offers significant business benefit in that well understood, capable and controlled processes form the basis for day to day manufacturing and testing operations.

Reigster

Why You Should Attend

This workshop will provide a concise, pragmatic introduction to the validation lifecycle – covering analytical, facilities, utilities and equipment, computer systems, process validation and cleaning validation.

You will get an overview on 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 will learn the correct approach whilst also formulating your own compliance plans to take forward.

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 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 Would Benefit

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

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 spent time developing and implementing lifecycle approaches to process validation across the R&D and manufacturing organizations and supported a number of new products introductions for both API and secondary filing.

Workshop Fees

Workshop cost (excluding VAT)  £710.00

DISCOUNTS AVAILABLE

Early bird and multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators and charities - contact us for details.

Have a question or want to book a place? Contact pharmacourses@nsf.org - you can also register online by clicking below.

You may also be interested in the one day Cleaning Validation workshop which is taking place the following day at the same location. 

Register