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Regulatory Affairs Certificate

Lehigh University



In today's world it has become crucial for employees working in the pharmaceutical, biotech, and medical device manufacturing industries to understand the regulatory environment in which they work.

With the Regulatory Affairs Certificate online program, employees working in pharmaceutical, biotech, and medical device manufacturing companies who deal with regulatory and FDA issues in the workplace, those in the legal profession working with FDA law and regulations, and others interested in the field will gain a general understanding of the Regulatory Affairs environment. They will also gain a broader understanding of the FDA and how it works, along with an understanding of FDA requirements covering the manufacture of drugs and vaccines, the risks and costs of non-compliance, and an understanding of the process, and strategies used to get a product to market.

One must understand chemistry and chemical engineering in order to write the FDA-required protocols on pilot plant operations, on quality control assays, or on impurity profiles of the drug substances.

All Applicants to this program should possess a basic understanding of organic chemistry and principles of analytical chemistry before beginning the program.

Accreditation Information

Middle States Association of Colleges and Schools, Commission on Higher Education

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