2021 - Lifecycle Management of Analytical Methods and Procedures according to new USP and ICH Guidelines

Day 01(10:00 AM - 5:00 PM EST)
10.00 AM - Session Start
Introductions and Agenda Review Lectures
Lecture 1 - Regulatory background and guidance
The importance of analytical procedures
Introduction to lifecycle management of analytical methods
USP approach for lifecycle management: proposed General Chapter 1220
Learnings from the new FDA, WHO and PDA method validation guidelines
Linking the procedure lifecycle to the quality system
The importance of risk management (ICH Q9)
Lessons from recent FDA Warning Letters
Recommendations for risk-based implementation
Lecture 2 - The 2015 FDA Method Validation guidance
Scope and regulatory status
Recommendations for integrated procedure lifecycle
Expectations for quality risk assessment, Quality by Design (QbD), Multivariate experiments, system suitability testing, statistics, knowledge management
Equipment operational qualification and trend analysis
Revalidation vs. ongoing evaluation
Lecture 3 - Preparing your laboratory for compliant validation studies
Analytical Instrument qualification
21 CFR Part 11/Annex 11 compliance of computer systems
Validation of chromatographic data systems
Validation and control of Excel spreadsheets
Qualification of reference standards and materials
Lecture 4 - The lifecycle overview on integrated method development, validation, and ongoing performance verification
Advantages of the new approach
Key steps for design, development, validation and ongoing performance verification
Integrated lifecycle and QbD: similarities, differences
Regulatory status of the new approach
Integrating method transfer and compendial method verification
Application of risk management through the life cycle
Day 02(10:00 AM - 5:00 PM EST)
Lecture 5 - The analytical target profile
Comparison with the scope of current methods
Advantages and limitations of the ATP approach
Introduction to measurement uncertainty
Target measurement uncertainty (TMU)
Considerations for establishing an ATP
Incorporating current USP, ICH and FDA guidance into the ATP
Constructing an ATP for existing methods
Lecture 6 - Procedure design and development
Knowledge gathering: what and how
Risk management: assessment, evaluation and control
Analytical control strategy
Typical control examples
Illustration of controls using Ishikawa (fishbone) diagrams
Knowledge management as an important factor in ensuring the acquiring, analyzing, storing and disseminating information
Lecture 7 - Procedure Performance Qualification (Validation)
Developing a validation/qualification plan and SOP
Going through ICH Q2 validation and test parameters:
Accuracy, precision, intermediate precision, specificity, LOD, LOQ, linearity, range, robustness
Examples for design and execution of test experiments
Examples of application-specific acceptance criteria
Evaluation of test results: using statistical models
Lecture 8 - Ongoing Performance Verification
Objective of ongoing performance verification
Monitoring method performance: system suitability testing and quality control samples
Handling of method changes vs. permitted adjustments
Revalidation of analytical methods: when, what to test
Handling of out-of-expectation results
Continuous improvements