Pharma Industry Quality Assurance and Regulatory Affairs

Course Features

Course Instructor: Vanercia
Who should do it: Bachelors (Pursuing / Completed) and above
Assessment:Exams at end of course, Quiz and Assignments
Certificate: Yes

Course Details

The Covid pandemic has changed the way the world now looks at research, development and distribution of drugs and vaccines. A new concept of assembly line has emerged for the manufacturing of pharmaceutical drugs and devices. This has, however, also stressed upon the stringent control for following appropriate manufacturing practices. This course provides insight into the requirements needed for research, testing, development, approval and commercialization of drugs, vaccines and medical devices.

Career Options

Good manufacturing practices, quality assurance and regulation are nowadays very important at all stages of the research, development and commercialization of pharmaceuticals, nutraceuticals, and other biological products. The specialized knowledge of good manufacturing practices, quality assurance and regulation enables professionals to be employable in biotechnology, medical device production houses, and pharmaceutical and food industries. Professionals can be associated with industry as regulatory associates, pharma regulatory consultant, drug safety specialist, quality assurance professional as well as regulatory food safety expert.

Learning Outcomes

• The course provides an introduction to rules and regulation required for good manufacturing practices and quality assurance.
• The course apprises students with procedures to be compiled throughout the manufacturing process of drug and device for human consumption.
• The course includes study material, presentations and projects on the inputs from academia and industry.
• Quiz and assignments based on modules covered, for practice.

Course Modules

• Good Manufacturing Practices, Quality Assurance and Regulation
• Regulation Practices and Procedure in Pharma Sector
• Patents, IPR and Regulation
• Regulatory Bodies and Pharma Regulatory Regimes (USA, EU and India)
• Regulatory Compliance for Pharma and Biotech Products (USA, India and other countries)