Method Development and Validation for Assays Supporting Testing of Biologics 2019 is a seminar that covers topics such as:
- Understanding the different requirements for small versus large molecules
- Mapping appropriate timelines with decision points
- Designing, developing, optimizing, and validating key methods
- Potency methods, other release and stability methods
- Preclinical and clinical methods
- Use of DOE and statistical analysis
- Handling of critical materials
- Process monitoring concepts
- Assessment of orthogonal methods
- Assessing readiness for validation
- Defining the validation protocol with real-time capture of data analysis
- Maintaining quality through documentation
Method Development and Validation for Assays Supporting Testing of Biologics 2019 brings together:
- Validation Scientists
- QA/QC
- Regulatory Affairs
- Laboratory Managers
- Assay Development Specialists
- Statistician
- CMC Titles
- Bio Assay
