This course provides a comprehensive understanding of Chemistry, Manufacturing, and Controls (CMC) in the pharmaceutical industry, including the product life cycle, manufacturing processes and controls, analytical procedures, and regulatory requirements.
Students will learn about the pharmaceutical product life cycle and the role of CMC in each stage of the cycle. The course will cover the manufacturing processes and controls involved in the production of pharmaceutical products, including the development and validation of manufacturing processes and the management of manufacturing changes.
In addition, the course will address the analytical procedure sections of pharmaceutical products, including method development and validation, and the importance of analytical testing during the manufacturing process.
The course will also cover the International Conference on Harmonization (ICH), the Common Technical Document (CTD) Quality Overall Summary (QOS) and CTD Module 3 requirements overview. Students will gain an understanding of the requirements for CMC submissions, including the structure and content of CMC documents and the importance of compliance with regulatory guidelines.
Furthermore, the course will provide a detailed overview of the full ICH stability storage and testing requirements for pharmaceutical products, including the requirements for stability studies, storage conditions, and testing intervals.
Learning Points:
This course is ideal for students interested in pursuing a career in pharmaceutical manufacturing, regulatory affairs, or related fields. The course is also relevant for professionals working in the pharmaceutical industry who want to expand their knowledge of CMC and its impact on drug development and commercialization.
