Description:
Recently the FDA has released a new comprehensive guidance for validation of analytical methods. The guidance applies 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 the seminar will learn everything about the background and principles of the guidance.
For easy implementation, attendees will receive
Checklist: Validation of Analytical Methods according to the FDA Guidance 2014
SOP: Validation of Analytical Methods
Example: Validation Report for Analytical Methods
Areas to be Covered:
Scope and content of the guidance
Going through validation parameters, tests, and acceptance criteria
Comparison with ICH Q2
Lifecycle management of analytical procedures
Periodic review and revalidation
Analytical method comparability studies for alternative analytical procedures
Analytical method transfer studies
Development experiments that should be conducted under GMP conditions
Application of QbD components: design space, multivariate experiments, risk assessment
Documentation requirements
Verification of submitted methods at the FDA
Reporting post-marketing changes to an approved method
Who will Benefit:
A must attend webinar for professionals in Pharmaceutical and medical device industry, Manufacturers of drug substances (APIs) and Contract laboratories. The teams that will benefit the most are:
Laboratory managers and staff
Analysts
QA managers and personnel
Regulatory affairs
Training departments
Documentation department
Consultants
Validation specialists
