Topics
- Examples of warning letters and how to avoid them
- FDA regulations and guidelines
- Developing an SOP for method validation
- USP Chapters and ICH Guides
- Prerequisites for method validation
- Development of a validation plan for success
- Defining test conditions and acceptance limits
- Defining the minimum number of validation experiments that satisfy ICH, FDA and USP
- To revalidate or not after method changes
- Verification of compendial methods according to USP [1226]
- Seven most common method validation pitfalls and how to avoid them
- Transferring a method to routine according to USP [1224]
- Documentation for the FDA and for other agencies
- Using software for automated method validation
Who should Attend
GLP/GCP/GMP auditors, Laboratory managers and supervisors, QA/QC managers and personnel, ISO 17025 auditors, Regulatory affairs, Analysts and other laboratory staff, Consultants and Training departments.
