All You Need to Know About Process Validation
Course
In Mayfield
Description
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Type
Course
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Location
Mayfield
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Duration
3 Days
At the end of the course delegates should have gained: An understanding of the principles of validation. An understanding of the requirement to validate. Knowledge of the type of information required from R&D to support the validation at the commercial site.
Facilities
Location
Start date
Start date
Reviews
Teachers and trainers (1)
Dr Clive Moores
Consultant (formerly Glaxo SmithKline)
Clive Moores was awarded his D.Phil. by Sussex University in 1973 for research work in Synthetic Organic Chemistry with Professor Douglas Young. He then worked for GD Searle for 4 years as a team leader in chemical development. In 1977 he moved to GlaxoSmithKline. He has spent 19 years in process research and development developing new synthetic processes and transferring process from lab to plant and hence into manufacture. ...
Course programme
A Course for Process Research and Development Chemists
The validation of a commercial process to manufacture active pharmaceutical ingredients (APIs) and their intermediates starts during the development process. A number of systems supporting the preparation of APIs for clinical trials must be validated. The data supporting the eventual process validationmust be robust and could be inspected by regulatory authorities. For these reasons it is imperative that chemists involved in these activities have a good understanding of the requirements for validation at the development level, what is required to validate a chemical process and the support that is required at the manufacturing site.
Course Outline
Overview of Validation
• What is validation and why is it required?
• Regulatory requirements and guidelines
• Validation in R&D and commercial environments
• Types of validation
• Validation vs qualification
Validation of a Chemical Process
• Critical stages and process parameters
• Starting materials and intermediates
• Suppliers
• Equipment
• Calibration vs validation
• Training
• Validation protocols
• Acceptance criteria
• Resolution of exceptions
• Validation report
Maintenance of the validated state
• Change control
• Trending
• Failure investigations
• Corrective and preventive actions
All You Need to Know About Process Validation