2021 - Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)

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)
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
Risk-based approach to method verification - which validation parameters should be verified?
Method verification acceptance criteria
Day 02(10:00 AM - 5:00 PM EDT)
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
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