The basic module is designed to provide students knowledge of applied pharmaceutical sciences, Chemical and Regulatory affairs. Novel concepts in leading edge industrial pharmaceutical research, Quality Assurance and Compliance are a major component of the module.

This course provides an overview of the pharmaceutical industry, including basic information about FDA requirements and approval processes, the role of key operational units in QA/QC, drug manufacturing processes, Production record and Batch record. This course enables the students to: understand the role of the pharmaceutical industry in the global market and its implication.

This intermediate course is focused on 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 in the industries response and the methodologies it uses to comply with these regulations.

The course includes a background in pharmaceutical sciences and introduces new concepts in pharmaceutical quality control, statistics, regulatory affairs and GMP. A crucial component of the foundation module is the introduction of pharmaceutical ethics and law, which prepares students for dealing with drug regulatory issues and compliance .The Pharmaceutical Quality Assurance & Quality Control program combines theoretical knowledge with hands-on skills in all areas that impact drug quality. Practical experience is gained in pharmaceutical quality control, Batch record review and processes, technical writing skills, regulatory compliance and proper documentation procedures. Some of the skills obtained during the program include:

The advanced module provides an opportunity to engage in independent method development, processes validation, method validation and research projects.

Courses covers HPLC/GC analysis, method development and validation techniques in pharmaceutical industry. HPLC/GC trouble shooting in detail for peaks and their parameters that governs integration. HPLC parts identification and purchase from the vendors. Lamp change and instruments seal replacement. Basic idea for cleaning validation in CFR 21 part 210 and 211. FDA regulations in R&D department.

Students who are at the final stages of their program and have excelled in all aspects of their training may apply their expertise for an internship. These opportunities allow selected students to gain additional experience through working with staff and faculty on one of the many unique projects undertaken at the Institute.