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NCTM1101 – Introduction to Pharmaceutical Manufacturing
August 31, 2020 @ 8:00 am - 5:00 pm
Online Course*
Description
This asynchronous online course comprehensively discusses the fundamental elements associated with the development and manufacture of pharmaceutical products. Training modules discuss the categories of pharmaceutical products, phases of pharmaceutical discovery, development, approval, and varying manufacturing processes (chemical or biological). The curriculum also reviews regulatory agencies and their roles, current Good Manufacturing Practices (cGMP) and GXP, quality assurance and control, and finishes with an exploration of career paths within the pharmaceutical manufacturing industry.
What will you learn:
- Understand the basics of pharmaceutical manufacturing, drug categories, target site, drug substance /product, different industry sectors and the different types of manufacturing companies
- Introduce the concept of regulations, major legislation, FDA jurisdiction and enforcement and Standards and guidelines
- Illustrate the stages of pharmaceutical product development process, discovery through post marketing surveillance and other licensing applications
- Learn the different types of manufacturing processes and be able to differentiate between upstream and downstream processes for large and small molecules, also about equipment and master production record
- Overview of cGMP, quality system requirements, quality assurance and quality control, cleanroom requirements and careers in pharmaceutical manufacturing
Section Description
Online Course – Further instruction will be sent after registration.