CMC Biopharma MasterClass 3.0

Topics

• Analytical and Formulation Development
• Process Development Strategies
• Process Analytical Technology
• GMP Manufacture
• Guidelines and Regulatory Pathways for New Biological Entities and Biosimilars

Who should Attend

• Stability program managers
• QC release and stability analysts
• Process analytical chemists and process development scientists
• Product scientists and test method technical experts (R&D and QC)
• GMP compliance auditors
• Quality assurance specialists
• Analytical and stability laboratory managers (R&D through GMP)
• Regulatory affairs CMC authors or reviewers
• Business managers with CMC responsibilities
• Project managers with CMC responsibilities
• Contract testing labs
• Key staff from biotech academic incubators and small start-ups
• Biopharmaceuticals, biosimilars
• Chemistry, Manufacturing & Controls (CMC) regulatory
• Executive and operational managers of pharmaceutical companies, packaging operations
• Or other biologics
• Quality
• Engineering staff
• Product Information Operations
• Product Development Materials handling/management
• Biotech companies HTAs
• Licensing