Why Should You Attend:
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data.
In this interactive one-day on-line seminar the speaker will give an introduction to FDA, USP and ICH and other requirements and present approaches for implementation. Attendees will have the opportunity to ask questions and get practical experience through exercises that are inter-dispersed within and between the presentations.
Attendees will receive full set of validation documents that can be used as templates and examples for validating user applications.
Areas Covered in the Seminar: - FDA/EU, ICH, USP and ISO 17025 requirements, regulatory expectations and inspection practices.
- FDA enforcement and inspection practices: Examples of FDA Warning Letters.
- Nine validation parameters and acceptance criteria for method validation.
- Writing the validation plan.
- Designing the sequence of experiments for highest efficiency.
- Evaluation and presentation of validation results according to ICH.
- Writing the validation report.
- Verification of compendial methods according to USP <1226>.
- Transfer of analytical methods according to USP <1224>.
