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
Who should Attend
Validation Scientists
QA/QC
Regulatory Affairs
Laboratory Managers
Assay Development Specialists
Statistician
CMC Titles
Bio Assay
Past Events
Method Development and Validation for Assays Supporting Testing of Biologics 2019 - 28-29 Mar 2019, San Francisco, California, United States (70629)
Important
Please, check "Method Development and Validation for Assays Supporting Testing of Biologics" official website for possible changes, before making any traveling arrangements
Event Categories
Business: Quality assurance
Education: Training
Health & Medicine: Medical device, Medical laboratories, Medical technology, Pharma
