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 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 chapters for integrated validation, verification and transfer of analytical procedures, for equivalency testing and for statistical evaluation.
This 2-day workshop will give attendees the background to understand the requirements, and even more significantly, it will focus on strategies and provide tools to implement most critical requirements. It will also provide 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 real life examples. After the course a variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what attendees have learned in the course.
Learning Objectives:
- 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
- Be able to explain the different requirements for validation, verification and transfer of analytical procedures
- Understand the principles of validating methods developed in-house, verification of compendial methods, transfer of analytical procedures and demonstrating equivalency to compendial 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 define and demonstrate FDA and EU compliance to auditors and inspectors
- Be able to develop inspection ready documentation during on-going routine operation
- Understand statistical evaluation of validation test results
- Understanding what questions will be asked during audits and inspections and how to answer them
Handouts/ Bonus Material for Easy Implementation (available as web downloads):
- 70-page primer: Validation of analytical methods (authored by Dr. Ludwig Huber)
- 10 SOPs related to validation, verification, transfer, review and change of analytical methods
- 10 checklists, templates and examples
- Acceptance criteria for different analytical tasks
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
- 08.30 AM - 09.00 AM: Registration
- 09.00 AM: Session Start
- Day 1 – Lectures and Workshop Exercises
- Lecture 1:
Regulatory Background and Requirements- FDA and international requirements
- The importance of ICH Q2 and USP chapters
- USP approach for method validation: New/revised Chapters 220, 1200, 1210, 1220, 1225
- Learnings from the NEW FDA and WHO method validation guidelines
- Different requirements for GLP, GCP and GMP
- The importance and steps of risk assessment
- Exercise: Define risk numbers for different methods
- Lessons from recent FDA Warning Letters
- Planning for cost-effective implementation
- Lecture 2:
Preparing Your Lab for Validation Studies- Analytical Instrument qualification
- Part 11/Annex 11 compliance of computer systems
- Validation of chromatographic data systems
- Validation and control of Excel spreadsheets
- Qualification of reference standards and materials
- Lecture 3:
Validation of Analytical Methods and Procedures- Developing a validation plan and SOP
- ICH Q2 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
- Evaluation of test results: using statistical models
- Handling deviations from expected test results
- Going through an example validation report
Verification of Compendial 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
- Which validation parameters should be verified
- Logical process to set acceptance criteria
- Exercise: Application based verification testing
- Day 2 – Lectures and Workshop Exercises
- Lecture 5:
Transfer of Analytical Methods and Procedures- The main objective of formal method transfer
- Learnings from EU GMP Chapter 6 on method transfer
- USP <1224> : Choosing the approach for transfer
- Approach and benefits of comparative testing:
- Developing a risk based test plan
- Planning and developing an effective transfer protocol
- Preparing the receiving lab for the transfer
- Method transfer to new technology:: HPLC to UHPLC
- Preparing the method transfer report
- Exercise: Application specific comparative testing
- Lecture 6:
Demonstrating Equivalency to Compendial Methods- Method validation vs. equivalency testing
- Definition, objective and scope of alternative methods
- Justification for the use of alternative methods
- FDA and USP requirements
- Options for alternatives to approved procedures
- Exercise: Equivalency testing - what and how much
- Documentation requirements
- Lecture 7:
Maintaining the Validated State- Monitoring method performance: system suitability testing and quality control samples
- Change control procedure for analytical methods
- Handling method changes vs. adjustments
- Revalidation of analytical methods: when, what to test
- Method reviews as a cost effective alternative to time based revalidation
- Going through a review process
- Regulatory reporting of post-approval changes
- Examples for continuous improvements
- Lecture 8:
Special Applications and Validation Processes- Preview to the expected new USP general chapter <1220> “The Analytical Procedure Lifecycle”
- Method development and validation using Quality by Design principles following the new FDA Guidance
- Validation of bioanalytical methods according to the FDA and EMA guidelines
- Validation of stability indication method
Dr. Ludwig Huber
Chief Advisor - Global FDA Compliance, Labcompliance
- Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
- Served as team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on Laboratory Systems.
- Presenter of the Year of the Institute for Validation and Technology
- Director and chief editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories.
- Author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems"
For more information, visit www.ludwig-huber.com/qualification
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