Validation of Analytical Methods according to the New FDA Guidance



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
QA managers and personnel
Regulatory affairs
Training departments
Documentation department
Validation specialists

Dr. Ludwig Huber

Ludwig Huber, Ph.D., is the director of Labcompliance and editor of (, 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, 21CFR Part 111 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies. For more information, please visit Dr.Huber’s website (


  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT

  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance