Скачать или смотреть GRCTS Webinar: Validation of Analytical Methods according to the New FDA Guidance

GRCTS Webinar: Validation of Analytical Methods according to the New FDA Guidance

Click Here for more information - https://www.grcts.com/FDA-Validation-...

You can contact us here - www.grcts.com | [email protected] | +1 248 233 2049

FDA has released a new comprehensive guidance for validation of analytical methods. The guidance follows the modern integrated life cycle 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.

Areas we will be Covering:

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 re-validate 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

Handouts:

Standard Operating Procedure - Validation of Analytical Methods
Transfer of Analytical Methods
Verification of Compendial Methods


GRCTS Webinar: Validation of Analytical Methods according to the New FDA Guidance

Click Here for more information - https://www.grcts.com/FDA-Validation-...

You can contact us here - www.grcts.com | [email protected] | +1 248 233 2049