HPLC Method Development & Validation Procedures

Venue: New Jersey

Location: New Jersey, United States

Event Date/Time: Jan 26, 2009 End Date/Time: Jan 27, 2009
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A Two Day, Comprehensive and Interactive Course on:

- Laboratory Control Issues for cGMP /GLP compliance
- USP, ICH, WHO, AOAC, ISO Guidelines and Standards
- The Quality Connection and FDA’s New Directives – PAT
- Conformity Assessment in the Analytical Laboratory
- Process Model for Methods Development
- NDA, ANDA & IND Submissions and Regulatory Requirements
- Rationale of Methods of Development and Validation
- Detection and Quantification in Analytical Chemistry
- Statistical Applications - SPC,SQC
- Data Integrity and Data Analysis
- Establishing Validation Parameters
- Developing Validation Protocols
- Considerations for HPLC Method Development
- Resolution, Capacity Factor, Column Efficiency and Mobile Phase Optimization
- Recent Developments, Miniaturization and UPLC
- Instrument Validation and Qualification