Learning Objectives:

• 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 will Benefit:

Below titles working in biopharmaceuticals, pharmaceuticals, natural products/botanicals will be benefited by attending this seminar:

• Validation Scientists
• QA/QC
• Regulatory Affairs
• Laboratory Managers
• Assay Development Specialists
• Statistician
• CMC Titles
• Bio Assay