This course provides an overview of the pharmaceutical industry, including basic information about drug discovery and development, FDA requirements and approval processes, drug dosage forms, and the role of key operational units in drug manufacturing processes. This course enables the students to: understand the role of the pharmaceutical industry in the global market and its implications; learn the fundamentals of the drug development cycle and the investment required to bring a drug to market; learn the most important drug manufacturing processes and the key elements of dosage formulation.
After completing Pharmaceutical Manufacturing: An Introduction, students will be equipped with a basic understanding of the following:
- understand the role of the pharmaceutical industry in the global market and its implications;
- learn the fundamentals of the drug development cycle and the investment required to bring a drug to market;
- learn the most important drug manufacturing processes and the key elements of dosage formulation.
No prior experience or coursework required.
Students will be assigned 5 homework assignments, and a final project for each course.
- Introduction to pharmaceutical manufacturing industry, including regulatory compliance, GMP, QA, CFR Part 11, validation issues, and FDA inspections
- Active pharmaceutical ingredients (API), chemical process technology
- Biochemical process technology
- Aseptic pharmaceutical manufacture
- Simple solution systems
- Semi-solid dispersed systems
- Pharmaceutical powders and encapsulation operations
- Pharmaceutical granulation and compression operations
- Pharmaceutical coating operations
- Aerosols and transdermal drug delivery systems
- Pharmaceutical packaging operations
- Pharmaceutical facilities
This course is Instructor-led and delivered through our award-winning online Learning Management System