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ANALYTICAL METHODS
VALIDATION
Conference Date: To be announced
Conference Ref: tbc
Venue: To be announced
Date in 2011 to be confirmed
Please contact us for further information and a brochure info@management-forum.co.uk
The demonstrable validity of analytical methods and systems used to generate data either in support of INDs, NDAs or Marketing Authorisation is seen by Regulatory Authorities as a key area for compliance. Proper procedures and practices for development and validation of analytical methods and procedures are necessary for the establishment of a scientifically sound baseline to support product release and on-going stability testing. In addition, the statistical evaluation of the data generated is critical to support the validation effort.
The objective of this seminar is to provide delegates with:
- An understanding of the requirements for method validation
- A knowledge of current best practices for cost effective compliance
- Practical advice on approaches to calibration, qualification and validation approaches
- Hands on experience of best practices through worked examples and a case study