Understanding the Final FDA Guidance for Validation of Analytical Methods

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 in which FDA regulated methods will be developed, validated and used. Because of the novelty of some of the concepts, the industry has difficulties to implement the guidance. The seminar will make it easy to understand and implement the guidance.

For easy implementation, attendees will receive:

• 2 SOPs
• Validation of Analytical Methods
• Verification of Compendial Methods
• Checklist
• Validation of Analytical Methods according to the new FDA Guidance

Areas Covered in the Session :

• Key differences to the existing and the new guidance
• 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
• Verification of compendial methods
• Analytical method comparability studies for alternative procedures
• Method transfer studies
• Development experiments that should be conducted under GMP conditions
• Application of QbD components: design space, multivariate experiments, risk assessment
• Documentation requirements
• Reporting post-marketing changes to an approved method

Who Should Attend:

A must attend webinar for professionals in Pharmaceutical development and quality control companies, medical device industry, Manufacturers of drug substances (APIs) and Contract laboratories, Clinical Research Organizations. The teams that will benefit the most are:

• QC Departments
• QA Departments
• Analysts and Lab Managers
• Regulatory Affairs Departments
• Training Departments
• Documentation Departments
• Consultants

Course Director: 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).