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 the 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 session 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 the 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.

Agenda:-

Day 01 (10:00 AM EST - 05:00 PM EST)

• 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)
• 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
• 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
  • The risk-based approach to method verification - which validation parameters should be verified?
  • Method verification acceptance criteria

Day 02 (10:00 AM EST - 05:00 PM EST)

• 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
• 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
  • A 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

Who Will Benefit:-

• Quality assurance personnel
• Quality control and method development analysts
• Validation specialists
• Laboratory managers and supervisors
• Regulatory affairs personnel
• Consultants