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:
鈥ppreciate the need to validate or verify your plant cleaning
鈥ully understand the documentation and legal requirements
鈥nderstand and be able to carry out the important operation of 'Walking the Plant'
鈥ecognise good and bad practices
鈥e able to calculate acceptance criteria
鈥learly identify what constitutes 'visually clean'
鈥e aware of the issues surrounding sampling and testing techniques
鈥ppreciate 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:
鈥perations managers and personnel
鈥alidation specialists/consultants - especially cleaning validations
鈥A and QC managers and personnel
鈥roduction engineers
鈥颈肠谤辞产颈辞濒辞驳颈蝉迟蝉
鈥uality systems auditors
鈥upplier 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:
鈥ppreciate the need to validate or verify your plant cleaning
鈥ully understand the documentation and legal requirements
鈥nderstand and be able to carry out the important operation of 'Walking the Plant'
鈥ecognise good and bad practices
鈥e able to calculate acceptance criteria
鈥learly identify what constitutes 'visually clean'
鈥e aware of the issues surrounding sampling and testing techniques
鈥ppreciate 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:
鈥perations managers and personnel
鈥alidation specialists/consultants - especially cleaning validations
鈥A and QC managers and personnel
鈥roduction engineers
鈥颈肠谤辞产颈辞濒辞驳颈蝉迟蝉
鈥uality systems auditors
鈥upplier auditors
