Analytical methods used for GxP purposes should be validated to ensure the 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 or a transfer waiver, if justified. If a laboratory uses an alternative method instead of a compendial method, equivalence or superiority of the alternative method should be demonstrated.
Recent guidance on method validation and transfer has been produced by FDA and EMA, and USP has guidance chapters on method validation, verification and transfer, equivalence testing and statistical evaluation. Articles in US Pharmacopeial Forum have introduced the concepts of measurement uncertainty and lifecycle management for analytical procedures. Lifecycle management has also been the subject of recent FDA and ICH publications.
This 2-day seminar will help attendees to understand regulatory requirements for method validation, verification and transfer. It will also suggest ways to de-risk the method validation process through prior evaluation of method performance and the use of effective protocols.
Recent guidance on method validation and transfer has been produced by FDA and EMA, and USP has guidance chapters on method validation, verification and transfer, equivalence testing and statistical evaluation. Articles in US Pharmacopeial Forum have introduced the concepts of measurement uncertainty and lifecycle management for analytical procedures. Lifecycle management has also been the subject of recent FDA and ICH publications.
This 2-day seminar will help attendees to understand regulatory requirements for method validation, verification and transfer. It will also suggest ways to de-risk the method validation process through prior evaluation of method performance and the use of effective protocols.
Learning Objectives:
- Understand the regulatory requirements for validation of analytical methods
- Learn how to plan, execute and document development and validation of in-house methods
- Be able to explain the different requirements for validation, verification and transfer of analytical procedures
- Understand the principles of validation of in-house methods, verification of compendial methods and method transfer
- Know how to demonstrate equivalence to compendial methods
- Understand the important qualities of stability-indicating methods
- Be able to select test parameters, test conditions and acceptance criteria for different analytical measurements
- Know how to plan, justify and document revalidation after method changes
- Understand important indicators of the suitability of a method for routine QC use
- Understand approaches for the statistical evaluation of validation test results
- Understanding what questions will be asked during audits and inspections and how to answer them
Course Content
Day 01(10:00 AM - 5:00 PM EDT)10:00 AM Session Start
Day 1 - Lectures and Workshop Exercises
- Lecture 1: Regulatory Background and Requirements
- FDA, EMA and international requirements (ICH Q2, ICH Q12 and the proposed ICH Q14)
- Method validation terminology
- USP and Ph Eur guidance on method validation, verification and transfer:
- 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)
- 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
- 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
- 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
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
- 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
- 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
- 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
Reviews
Speaker is very knowledgeable and the supporting material provided by him is very helpful.SQA Compliance Auditor,
AbbVie Inc.
There is sufficient information in the seminar and the presenter is very professional.
Head of Quality,
Bayer HealthCare.
Definition of raw data and its relationship of e-signature application topic was most valuable to me as we were evaluating the gap in our company and this handy data before doing that will help us to get the requirement.
Assistant Manager,
QA, SHL Group Limited
Information and resources provided by Speaker is very informative. Additional resources provided by him has practical and applicable approach. What I have learned will be helpful in reinforcing compliance in the company with QA.
Assistant Manager,
Quality Assurance, EirGenix, Inc
Course Provider
Dr Mark Powell,
Fellow ,
Royal Society of ChemistryDr 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.
Who Should Attend
- Quality assurance personnel
- Quality control and method development analysts
- Validation specialists
- Laboratory managers and supervisors
- Regulatory affairs personnel
- Consultants
