Validation of Analytical Methods According to the New FDA Guidance

Why Should You Attend:

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 how FDA regulated methods will be developed, validated and used. Since these concepts are fairly new, the industry has difficulties in understanding and implementing the guidance. Through this webinar, attendees will learn everything about the background and principles of the guidance.

Participants will also receive effective hand-outs that include checklists and samples of validation reports. The webinar will focus on detailing all key components of the guidance and analyze its validation parameters, tests, and acceptance criteria.

Hand-outs:

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

Note: These complimentary hand-outs will be sent to customers on request. Please email [email protected] for these documents, stating your order number, and they will be emailed to you within 4 working days.

Areas Covered in the Webinar:

• 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:

• Personnel from the pharmaceutical and medical device industry
• Manufacturers of drug substances (APIs)
• Contract laboratory staff
• Laboratory managers and staff
• Analysts
• QA managers and personnel
• Regulatory affairs personnel
• Training department personnel
• Documentation department personnel
• Consultants
• Validation specialists

Instructor Profile:

Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. He has authored 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 includes seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national healthcare agencies.

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