Analytical Method Validation and Transfer

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Event Date/Time: Dec 07, 2010 End Date/Time: Dec 08, 2010
Registration Date: Dec 07, 2010
Early Registration Date: Nov 15, 2010
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Description

- FDA and International Regulations for Method Transfer
- Method validation according to ICH Q2 Guidelines
- Types of Method Transfer and Testing
- Strategies for Succesful Methods Transfer to Third Parties
- Common Failures during Methods Transfer
- Risk-based Method Transfer
- Knowledge Transfer – A Critical Input to a Successful Method Transfer
- Quality by Design for Analytical Methods – Implications for Method Transfer
- Method Transfer Protocols – Contents, Acceptance Criteria and Approvals
- SOPs on Technology Transfer and Method Validation
- Building a Successful Method Transfer Team
- Determining Gap Analysis on Analytical Method Transfer
- Transferring Analytical Methods Globally

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