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.
The intermediate module focuses on practical training in pharmaceutical experimental design, formulation technology and manufacturing techniques. Hands-on experience is acquired through team-based projects, in compliance with GMP and GLP, in our state-of-the-art research laboratories and manufacturing plant. Analytical techniques, problem solving, protocol and technical writing skills are acquired throughout the module.
This course is focused on the development of a working knowledge of the Federal Code of Regulations and its impact on the pharmaceutical and allied industries. The history of the Federal Governments regulation of the pharmaceutical industry is studied. Also covered are the industries response and the methodologies it uses to comply with these regulations
Upon completion of this module, trainees are exposed to full GMP compliance in a state-of-the-art pilot plant where they acquire hands-on expertise in granulation and compounding. In addition, this hands-on component fosters teamwork, problem-solving and troubleshooting skills to operate and maintain equipment under minimal supervision.
In this module, trainees gain an in-depth understanding of compression science, as well as the critical aspects involved in tablet making. While integrating GMP compliance, particular emphasis is given to the technical skills required for equipment operation, maintenance and troubleshooting. |