Course Overview

The regulatory expectations with respect to cleaning and cleaning validation have evolved with the introduction of requirements for so called ‘Health-Based Limits’ as part of cleaning acceptance criteria. Cleaning and cleaning validation continue to result in companies being cited for poor compliance of their cleaning and validation approach. This cleaning validation training workshop will summarize the current expectations and how these can be met in a pragmatic and practical manner.

Reigster

Why You Should Attend

This course will provide a concise approach to the development of cleaning processes and the subsequent validation of those processes – it will provide you with an overview on how you can apply this 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
  • Understand how to identify potential compliance gaps with regards to cleaning validation acceptance criteria
  • Know how to plan implementation of cleaning verification and validation
  • Know acceptance criteria and how to assess
  • Understand sampling for cleaning acceptance
  • Know how to maintain the validated state
  • Know how to present your strategy and data to a regulatory body

Who Would Benefit

This workshop is ideal for managers, supervisors and operators who are directly involved or responsible for cleaning validation or verification, setting or assessing compliance limits and an overall cleaning 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 Introduction to Validation workshop which is taking place the day before at the same location. 

Register