Ensuring Compliance of Your Bioanalytical Method Validation with the 2013 FDA Draft Guidance 2016

Topics

• Learning from the Crystal City FDA/Industry conference report
• FDA guidelines for bioanalytical method validation
• Development of a master plan and SOP for validation
• Logistics of validation
• Defining parameters and acceptance limits
• Preparation and use of reference standards and equipment
• Considerations for Microbiological and Ligand-binding Assays
• Defining validation experiments
• Transferring and using the method for routine analysis
• To revalidate or not after method changes

Who should Attend

Attendees from:

• QA managers and Personnel
• Managers and Analysts in bioanalytical laboratories
• Consultants, Scientists, Technologists, and Engineers in the pharmaceutical industry
• Validation Specialists
• Biotech R&D Staff
• Bioanalytical Scientists
• Biopharmaceutical Consultants
• Outsourcing Professionals