Course Scope
This practical 1-day 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!
Overview:
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
•Clearly identify what constitutes 'visually clean'
•Be aware of the issues surrounding sampling and testing techniques
•Appreciate the importance of analytical method validation
Who should attend:
This training is designed for those with responsibility for the design, execution, or validation of cleaning processes, who may include:
•Operations managers and personnel
•Validation specialists/consultants - especially cleaning validations
•QA and QC managers and personnel
•Production engineers
•Microbiologists
•Quality systems auditors
•Supplier auditors
This practical 1-day 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!
Overview:
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
•Clearly identify what constitutes 'visually clean'
•Be aware of the issues surrounding sampling and testing techniques
•Appreciate the importance of analytical method validation
Who should attend:
This training is designed for those with responsibility for the design, execution, or validation of cleaning processes, who may include:
•Operations managers and personnel
•Validation specialists/consultants - especially cleaning validations
•QA and QC managers and personnel
•Production engineers
•Microbiologists
•Quality systems auditors
•Supplier auditors
