Introduction to Validation Training
About This Course
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.
Each two-hour 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.
Key Learning Objectives
By the end of the courses you will understand:
- The current regulatory expectations relating to:
- Analytical validation
- Equipment, facilities and utilities qualification
- Process validation
- Cleaning validation
- Validation documentation requirements
- How each of the validation disciplines should be executed at your workplace
- Validation maintenance requirements
Who Should Attend
This training is an ideal introduction to validation for people who are new to the subject and are directly involved in or responsible for validation.
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.
Discounts offered to NHS staff, regulators and charities. Book all four bite-size validation courses together to receive an £85 discount and free access to our Computerised Systems Validation eLearning course.