Advanced CMC MasterClass

Topics

• Post-approval CMC changes
• Levels of requirements in CMC
• Stability requirements
• Essential requirements for a drug substance
• Requirements for packaging

Who should Attend

• Regulatory Affairs CMC authors or reviewers
• Quality assurance specialists
• Project managers with CMC
• Analytical and stability laboratory managers (R&D through GMP)
• Product scientists and test method technical experts (R&D and QC)
• Chemistry, Manufacturing & Controls (CMC) regulatory
• Process analytical chemists and process development scientists