A Two-Day Comprehensive and Interactive Course with Workshops and Discussions on:

- Revised General USP Chapter <467> on Residual Solvents
- Practical Approach to the Implementation of <467>
- Applying Risk Based Strategies
- Complying with FDA , ICH Requirements for Method Validation
- Validation of Impurities
- Designing Analytical Method Validation Protocols
- Determination of Acceptance Criteria
- Managing Validation Deviations and Failures, and Protocol Exceptions
- Preparing for and Documenting Change Control
- Documentation Management for Analytical Method Validation
- Format and Preparation of Validation Reports
- Revalidation and Methods Update
- Method Equivalency Comparison
- Instrument Performance Effects on Validation Experiment Results
- Compilation and Review of Data
- Differences between Qualification and
Validation applicability
- HPLC Analytical Method Validation
- Comparing HPLC, UHPLC, Fast Chromatography and UPLC
- Solid Phase Extraction