Training Overview
This MasterClass will provide a deep and detailed instruction on Chemistry, Manufacturing, and Controls (CMC) requirements and review processes for clinical trial, registration, and postapproval drug applications. Attendees will also have a solid but comprehensive overview of all relevant regulatory, technical, and quality elements, implementation, and documentation of the required CMC analytical and stability knowledge for biotechnology products, including biosimilar products. Practical examples will be provided as an illustration and proper time will be allowed for discussion designs and outcomes.
Learning Outcomes
• Process development strategies
• Analytical and Formulation development
• GMP manufacture
• Process analytical Technology
• Guidelines and Regulatory pathways for New Biological entities and Biosimilars
Who should attend
• QC release and stability analysts
• Stability program managers
• Product scientists and test method technical experts (R&D and QC)
• Process analytical chemists and process development scientists
• Quality assurance specialists
• GMP compliance auditors
• Regulatory affairs CMC authors or reviewers
• Analytical and stability laboratory managers (R&D through GMP)
• Project managers with CMC responsibilities
• Business managers with CMC responsibilities
• Key staff from biotech academic incubators and small start-ups
• Contract testing labs
• Chemistry, Manufacturing & Controls (CMC) regulatory
• biopharmaceuticals, biosimilars or other biologics
• Executive and operational managers of pharmaceutical companies, packaging operations
• Engineering staff
• Quality
• Product Development Materials handling/management
• Product Information Operations
• Licensing
• Biotech companies HTAs
• Governments
• Engineering Lean production
• Procurement
• Purchase/Facilities Manufacturing Technology
• Supply chain and logistics
• Payers
Trainer
