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
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation – the same as you would get in an in-person seminar
- Opportunities to connect with your peers to share knowledge at a different time and have group discussions
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- As usual more content, activities and case studies and now adding homework for a comprehensive understanding
- Certification
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
- 9:00 AM Session Start
- Day 1 – Lectures and Workshop Exercises
- Lecture 1: Regulatory Background and Requirements
- FDA, EMA and international requirements (ICH Q2)
- Method validation terminology
- Compendial guidance on method validation, verification and transfer:
- USP General Chapters 1033, 1092, 1210, 1224, 1225, 1226 and 1467
- Ph. Eur. 5.21 – Chemometric Methods applied to Analytical Data
- EU GMPs: Chapter 6 and Annex 15
- Recent FDA and WHO method validation guidelines
- Different requirements for GLP, GCP and GMP
- Recent FDA and EMA enforcement action regarding method validation
- Introduction to quality risk management (ICH Q9)
- Exercise: evaluating risk in method validation, verification and transfer
- Lecture 2: Preparing for Method Validation
- Analytical Instrument qualification (USP <1058>)
- Computerized data systems (21 CFR 11, EU GMPs Annex 11 and GAMP 5)
- Validation of chromatographic data systems
- Validation and control of Excel spreadsheets
- Qualification of reference standards and materials
- Evaluating method performance prior to validation
- Lecture 3: Validation of Analytical Methods
- Developing a validation plan and SOP
- Phase-appropriate method validation
- Experimental approaches to method validation: accuracy, precision, intermediate precision, specificity, LOD, LOQ, linearity, range and robustness
- Demonstrating specificity: stress studies and impurity standards
- Dealing with validation failures
- Exercise: example validation report
- Lecture 4: Verification of Compendial Methods
- Scope, objectives and requirements of USP <1226>
- Changes allowed to chromatographic methods: USP <621> and Ph. Eur. 2.2.46
- Risk-based approach to method verification - which validation parameters should be verified?
- Method verification acceptance criteria
- Exercise: planning a method verification exercise
- Day 2 – Lectures and Workshop Exercises
- Lecture 5: Transfer of Analytical Methods and Procedures
- Method transfer objectives
- Method transfer approaches
- Risks in method transfer
- Writing an effective transfer protocol
- Preparing the receiving laboratory for method transfer
- Method transfer to new technology: HPLC to UHPLC
- The method transfer report
- Exercise: planning a method transfer exercise using comparative testing
- Lecture 6: Demonstrating Equivalence to Compendial Methods
- Method validation vs. equivalence testing
- Definition, objective and scope of alternative methods
- Justification for the use of alternative methods
- FDA and USP requirements
- Equivalence testing - what and how much?
- Documentation requirements
- Lecture 7: Maintaining the Validated State (Lifecycle Management)
- Monitoring method performance: system suitability testing and quality control samples
- Change control for analytical methods
- Handling method changes pre- and post-approval
- Revalidation of analytical methods: when, and what to test
- Method review
- Continuous improvement
- Lecture 8: Recent Developments
- Lifecycle approach to analytical methods
- Method development and validation using Quality by Design principles
- Validation of bioanalytical methods according to the FDA and EMA guidelines
- Measurement uncertainty
Mark Powell
Director, Mark Powell Scientific Limited
Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.
