Ensuring Compliance of Your Bioanalytical Method Validation with the 2013 FDA Draft Guidance 2016 is a webinar that covers topics such as:
- 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
Ensuring Compliance of Your Bioanalytical Method Validation with the 2013 FDA Draft Guidance 2016 is intended for attendees from: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