Quality by Design (QbD) for Development and Validation of Analytical Methods

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Using the QbD approach for development and validation will result in more robust analytical methods. Advantages are easier method transfer, longer revalidation cycles and fewer or no methods specific Out-of-Specification situations when used in routine. In addition, FDA, USP and international agencies promote the QbD approach because it is expected that such performance based routine methods can be changed within the analytical target profile (ATP) without regulatory resubmission and approval. Moreover, the new FDA Method Validation Guide suggests using QbD elements for development and validation. Because there is no or little experience with the QbD approach for analytical methods, the industry has many questions.

For easy implementation, attendees will receive:
Master plan – Template and examples: Development and Validation of Analytical Methods through QbD
SOP – Development and Validation of Analytical Methods through Quality by Design
Checklist – Validation of Analytical Methods according to the FDA Guidance 2015

Areas to be Covered:

General principles and key benefits of QbD
Regulatory background and trends: FDA, ICH Q8/9/10
Reasons for changing the way we validate methods
Current applications of QbD in the pharmaceutical industry
The Application of QbD for analytical methods
Comparison of the QbD process with ICH Q2 and USP <1225>
Benefits for method transfer and routine use
Using the lifecycle approach for method design, development and validation
Developing specifications and, the analytical target profile
Documenting input variables for risk assessment in fishbone diagrams
Using the risk assessment prioritization matrix to select the test parameters
Traditional vs. the QbD process for method parameter optimization
The method validation and qualification studies
Using the method in the routine: on-going performance control, review and change control
Continuous monitoring and improvements
Documentation requirements
Defining the Analytical Target Profile (ATP) and design space
Case studies

Who will Benefit:

A must attend webinar for professionals in Pharmaceutical and medical device industry, Manufacturers of drug substances (APIs) and Contract laboratories, Contract manufacturing organizations, Clinical research organizations. The teams that will benefit the most are:
QA Managers and Personnel
Analysts and Lab Managers
Regulatory Affairs
Training Departments
Method Development Departments
Documentation Departments

Dr. Ludwig Huber

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, 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 (www.ludwig-huber.com).

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  • 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