Course Scope
This training is designed for those with responsibility for the design, execution, or validation of cleaning processes which may include operations managers and personnel, validation specialists, Quality Assurance and Quality Control managers, production engineers, microbiologists, quality systems auditors and supplier auditors.
This practical course covers basic issues in cleaning processes in pharmaceutical manufacturing, and the validation of those processes. After an introduction to the overall objectives, the course then covers process design, pitfalls and associated validation issues including sampling and testing. The course is designed so that the most important and fundamental issues associated with cleaning validation or verification are broken down and explained. Numerous practical exercises are run throughout, providing clear demonstrations of techniques to employ - and pitfalls to avoid!
Learning Outcomes
By the end of the course you will:
- Appreciate the need to validate or verify your plant cleaning
- Fully understand the documentation and legal requirements
- Understand and be able to carry out the important operation of ‘Walking the Plant’
- Recognise good and bad practices
- Be able to calculate acceptance criteria
- Be able to clearly identify what constitutes ‘visually clean’
- Be aware of the issues surrounding sampling and testing techniques
- Appreciate the importance of analytical method validation
