Description: 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.

1. GRC Training Solutions
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2. 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.
Description

3. • 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.
Topics

4. • QC managers
• QA managers and personnel
• Laboratory managers and supervisors
• Analysts
• Regulatory affairs
• Training departments
• Documentation department
• Consultants
Who will benefit (by Function)

5. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of
www.labcompliance.com, 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. For more information, please visit Dr.Huber’s website
www.ludwig-huber.com.
Instructor Profile