All You Need to Know About Process Validation

Course

In Mayfield

Price on request

Description

  • Type

    Course

  • Location

    Mayfield

  • 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

Mayfield (East Sussex)
See map
Maycroft Place, Stone Cross, TN20 6EW

Start date

On request

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Teachers and trainers (1)

Dr Clive Moores

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

Price on request