Entry Level CMC - US edition MasterClass

Chemistry, Manufacturing and Control (CMC) is key in the development and routine production of a medicinal product, and this course helps you understand the basic requirements and how to reflect them in the CTD Module 3. The course covers the general requirements for small molecules and biologics.

09-10 May, 2023, Virtual

Time Zone: Eastern Standard Time (EST) / UTC−05:00

Overview

Are ICH guidelines compulsory? What is the difference between analytical validation and analytical transfer? Do we need to test a compendial excipient? Chemistry, Manufacturing and Control (CMC) is key in the development and routine production of a medicinal product, and this course helps you understand the basic requirements and how to reflect them in the CTD Module 3. The course covers the general requirements for small molecules and biologics.
 

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RECOMMENDATION

Who should attend?

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