Bitesize Validation Series

Virtual Learning

March 9 – 30, 2022

Course Overview

This course total duration is 8 hours over 4 days. 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.

This training is part of a series of validation courses running at 2-4pm GMT on four consecutive Wednesdays from 9 March 2022 to 30 March 2022. This series of four two-hour bitesize virtual course provides an overview of the relevant guidance for each validation area and takes you through an interactive session where you will learn:

Cleaning: How to design your cleaning process, analytical methods and specifications to be used during cleaning validation as well as how to maintain the validated state

Analytical: Method verification, method validation, system suitability and method transfer

Process: The principle of validation, the validation lifecycle, quality by design, execution of process validation and continuous process verification

Equipment, facilities and utilities: The different stages of qualification from the URS to the performance qualification and how they should be executed

Each course uses scenarios and interactivity to support and strengthen the learnings.

The four bite-size courses, along with the computer systems validation eLearning, form a good foundation for anyone wanting to gain a good understanding of validation in the pharmaceutical industry.

Course Coach: Emma Ewins - Emma has over 20 years of experience in pharmaceutical operations management, technical services and QA, gained working for international pharmaceutical organizations. She has held roles in development, manufacturing, site leadership and QA where she has been responsible for fully outsourced operations, supply chains, process development, validation, engineering and manufacturing.