Quality by Design (QbD) for Development and Validation of Analytical Methods 2012

Topics

• Regulatory background and trends
• General principles of QbD
• The Application of QbD for analytical methods
• Current applications of QbD in the industry
• Benefits for method transfer and routine use
• Comparison with ICH Q2 and USP
• The timeline for method design, validation and verification
• Using the lifecycle approach for method design, development and validation
• Defining the Analytical Target Profile (ATP) and design space
• Documentation requirements
• Case studies

Who should Attend

• GLP and GMP auditors
• Laboratory managers and supervisors
• Analysts and other laboratory staff
• QA/QC managers and personnel
• Documentation department
• Regulatory affairs
• Consultants
• Training departments