Ensuring Compliance of Your Bioanalytical Method Validation with the 2013 FDA Draft Guidance 2016
24 Mar 2016
Webinar
Key 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
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Important
Please, check "Ensuring Compliance of Your Bioanalytical Method Validation with the 2013 FDA Draft Guidance" official website for possible changes, before making any traveling arrangements
