Two Day Online Validation, Verification and Transfer of Analytical Methods Seminar: Understanding and implementing Guidelines from FDA/EMA, USP and ICH - October 14-15, 2021
Dublin, Aug. 25, 2021 (GLOBE NEWSWIRE) -- The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH) 21" training has been added to ResearchAndMarkets.com's offering.
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.
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
Key Topics Covered:
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) 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
For more information about this training visit https://www.researchandmarkets.com/r/ohuzvw
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