3hr Virtual Seminar - Validation, Verification and Transfer of Analytical Methods – Implementing Guidelines from FDA/EMA, USP and ICH

Why Should You Attend:

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.

Method validation recently got highest attention from regulatory agencies and industry task forces. For example, FDA and EMA released guidelines on method validation and transfer, and USP has proposed new approaches and chapters for integrated validation, verification and transfer of analytical procedures, for equivalency testing and for statistical evaluation.

The 3 hour web seminar will give attendees the background to understand the requirements and even more importantly it will focus on strategies and provide tools to implement most critical requirements. It also provides templates and examples to develop inspection ready documentation. Interactive workshop exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions with life examples.

Learning Objectives:

1. Learn about the regulatory background and requirements for validation of analytical methods and procedures
2. Learn how to plan, execute and document development and validation of methods developed in-house
3. Understand the principles of validating methods developed in-house, verification of compendial methods, transfer of analytical procedures and demonstrating equivalency to compendial and other approved methods
4. Be able to explain your company’s strategy for method validation, verification, transfer and equivalency testing
5. Be able to select test parameters, test conditions and acceptance criteria for different analytical tasks
6. Be able to justify and document decisions about revalidation after method changes
7. Be able to define and demonstrate FDA and EU compliance to auditors and inspectors
8. Be able to develop inspection ready documentation during on-going routine operation
9. Understanding what questions will be asked during audits and inspections and how to answer them
10. 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

Areas Covered in the Webinar:

Part 1: Regulatory background and requirements

• 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
• Different method validation requirements for GLP, GCP and GMP
• The importance and steps of risk assessment for testing validation parameters
• Exercise: Define risk numbers for different methods
• Method revalidation and ongoing performance review
• Lessons from recent FDA inspections and Warning Letters
• Lifecycle approach and Quality by Design (QbD) for method development and validation

Part 2: Validation of analytical methods and procedures

• 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

Part 3: 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

Who Will Benefit:

• QA managers and personnel
• Quality Control
• Method development
• Analytical chemists
• Validation specialists
• Laboratory managers and supervisors
• Regulatory affairs
• Training Departments
• Documentation departments
• Consultants

Dr. Ludwig Huber
Director and Chief Editor, Labcompliance

Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. Dr. Huber 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 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.

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