System Suitability, Allowable Adjustments, and Data Quality in Chromatographic Systems 2017

Topics

• Discuss the factors that impact System Suitability and the relation of System Suitability to Instrument Qualification
• System Suitability as the start of the Quality Assurance Framework supporting chromatographic data reliability
• The selection of appropriate System Suitability parameters and the relationship of each parameter to support product quality
• The key elements of a Quality Assurance Framework
• Application & limitations of Allowable Adjustments
• The extension of System Suitability across a sequence
• Approaches to investigation of System Suitability failures
• The application of System Suitability in methods with multiple analytic

Who should Attend

• Manager of Analytical Development
• Director of Analytical Development
• Manager of Quality Control
• Director of Quality Control
• Chemists in both the ASRD and QC functions
• Pharmaceutical Supervisors
• Regulatory Affairs