GMP Training
Throughout the world, there is a need for cGMP education. This course is an important first step and provides an overview of all-important areas of cGMP. Highlights in this course are strategies for the manufacture of drugs for tuberculosis and other infectious diseases. A university level course is offered because cGMP regulations are rapidly changing due to changes in the industry, improved methods of analysis, and changes in the FDA and other regulatory bodies. High quality and appropriate compliance are essential for the success of pharmaceutical companies. Poor quality and non-compliance result in closed operations or organizations, fines, ruined careers and public images, and loss of credibility. The objective of this course is to introduce closed scientists throughout the world to the essentials of quality assurance, quality control, and quality systems. The course was developed to address the lack of broad education in regulatory sciences in conventional university curricula. For example, operations scientists are well trained in manufacturing and methods of analysis but few have any formal education on the policy and core principles of cGMP. This course provides a basic overview of regulatory issues enabling operations scientists, chemists, manufacturing professionals, and other researchers to perform well in their assigned capacities.

This program will enhance your abilities to locate and interpret laws and regulations relevant to the pharmaceutical industry, and then design, implement, and monitor “best practices” in your organization to assure compliance. Also, the program provides a broad and thorough understanding of the entire process of drug development: from early discovery and toxicology research, through clinical trials and manufacturing, and finally registration. The course provides education in the important areas of regulatory and quality compliance. In addition to a classroom education, the course is designed to provide hands-on practical experience working in the laboratory and at the Chao Center for Industrial Pharmacy and Contract Manufacturing at Purdue. Students will improve their knowledge of regulatory and compliance issues while developing familiarity with the manufacture of solid oral dosage forms following Current Good Manufacturing Practices (cGMP).

GMP Training Brochure (PDF Download)

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