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FDA has released a new comprehensive guidance for validation of analytical methods. The guidance follows the modern integrated lifecycle approach with related new requirements for using quality-by-design components, risk assessment, design space and continuous improvement. The guidance will significantly change the way how FDA regulated methods will be developed, validated and used. Because of the novelty of some of the concepts the industry has difficulties to understand and implement the guidance. Attendees of this seminar will understand and learn how to implement the new guidance.
- Key differences to the existing guidance
- Scope and content of the guidance
- Going through validation parameters, tests, and acceptance criteria
- Comparison with ICH Q2
- How to apply the lifecycle management for analytical procedures
- When and how to periodic review and revalidate methods
- Analytical method comparability studies for alternative methods
- Recommendations analytical method transfer studies
- Development experiments that should be conducted under GMP conditions
- Application of QbD components: design space, multivariate experiments, risk assessment
- Standard Operating Procedure - Validation of Analytical Methods
- Transfer of Analytical Methods
- Verification of Compendial Methods
Who will benefit (by Function)
- QC managers
- QA managers and personnel
- Laboratory managers and supervisors
- Regulatory affairs
- Training departments
- Documentation department
Ludwig Huber, Ph.D., is the director of Labcompliance. The global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China CFDA, ISPE, PDA, PIC/S and several other industry organizations and national health care agencies.