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Validity : 30th Apr'24 to 10th May'24
Validation, Verification and Transfer of Analytical methods and Procedures
Part 1: Regulatory background and validation of analytical methods
• FDA and international requirements
• The importance of ICH Q2 and USP chapters
• USP approach for method validation: USP Chapters 1220, 1224, 1225, 1226
• Learnings from the NEW FDA and WHO method validation guidelines
• The importance and steps of risk assessment for testing validation parameters
• Method revalidation and ongoing performance review
• Lessons from recent FDA inspections and Warning Letters
• Lifecycle approach and Quality by Design (QbD) for robust method development and validation
• Developing a validation plan and SOP
• ICH Q2 and USP 1225 validation and test parameters:
Accuracy, precision, intermediate precision, specificity, LOD, LOQ, linearity, range, robustness, ruggedness
• Examples for application specific acceptance criteria
• Examples for design and execution of test experiments
• Handling deviations from expected test results
• Going through an example validation report
• Different method validation requirements for GLP, GCP and GMP
Part 2 Verification of compendial and transfer of analytical methods
• FDA and equivalent international expectations
• Scope and objectives of USP <1226>
• USP <1226> verification requirements
• Risk based approach for type and extent of verification testing
• The main objective of formal method transfer
• Learnings from EU GMP Chapter 6 or method transfer
• USP <1224> : Choosing the approach for transfer
• Approach and benefits of comparative testing:
• Developing a risk based test plan for method transfer and verification
Overview of the webinar
Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing. In case a laboratory wants to use an alternative method instead of a compendial method, equivalency of the alternative method to the compendial method should to be demonstrated.
Since about 20 years there were no new guidelines from FDA and international agencies on analytical method validation. This has changed now: FDA did introduce a new very important guideline in 2015 entitled: Analytical Procedures and Methods Validation for Drugs and Biologics. Now after a grace period of three years FDA is expected to enforce the guidelines. Similarly USP, the European medical Agency and the WHO introduced chapters, regulations and guidelines on analytical method validation, verification and transfer. These guidelines are heavily enforced by agencies from different parts of the world resulting in warning letters and other enforcement actions
Who should attend?
• Quality Assurance managers and personnel
• Quality Control managers and personnel
• Method development chemists
• Analytical chemists
• Validation specialists
• Laboratory managers and supervisors
• Regulatory affairs staff
• Training specialist
• Documentation specialist
• Consultants
Why should you attend?
Analysts, supervisors and managers in analytical and quality control laboratories are advised to attend this seminar presented by the method validation expert Dr. Ludwig Huber
Mainly because attendees will
• Learn about the regulatory background and requirements for validation of analytical methods and procedures
• Learn how to plan, execute and document development and validation of methods developed in-house
• Understand the principles of verification of compendial methods, transfer of analytical procedures and demonstrating equivalency to compendial and other approved methods.
• Be able to explain your company’s strategy for method validation, verification, transfer and equivalency testing
• Be able to select test parameters, test conditions and acceptance criteria for different analytical tasks
• Be able to justify and document decisions about revalidation after method changes
• Be able to develop inspection ready documentation during on-going routine operation
• Understanding what questions will be asked during audits and inspections and how to answer them
• Understand current and future industry trends: new/revised USP chapters 1220/1225 “The Analytical Procedure Lifecycle” and Quality by Design (QbD) principles for method development and validation
Faculty - Dr.Ludwig Huber
Dr. Ludwig Huber, Ph.D., is the chief advisor 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, Informa Healthcare, and of the 70-page primer: Validation of Analytical Methods".
He has given more than 300 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.
Dr. Huber has been awarded as
• The Presenter of the year at IVT conferences, selected by thousands of attendee as #1 out of 175 presenters
• The Winner of the "First International GLP Award" from Indian Drug Manufacturer Association for Publications and Presentations in the Area of GLP and GMP
• Winner of the Wallhaeusser award, sponsored by the European Compliance Academy for publications in the area of 'Quality and Safety of Drugs'