CMC Excellence Mastery - US Version
02-03 December, 2024
Technical and regulatory requirements
ONLINE TRAINING | 02-03 December, 2024
Starting time: UTC 14:00 p.m.
Overview
Technical and regulatory requirements for developing a medicinal product are becoming stricter every day, the products themselves become more and more complex. This course will go through the key scientific points for the development and registration of your medicine, and provide a focus on US FDA and Europe expectations for CMC. The course covers general requirements for small molecules and biologics.
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Who should attend?
-Quality assurance specialists
-Regulatory Affairs CMC authors or reviewers
-Analytical and stability laboratory managers
-Project managers with CMC responsibilities
-Chemistry, Manufacturing & Controls (CMC) regulatory
-Product scientists and test method technical experts (R&D and QC)
-Process analytical chemists and process development scientists