Today it is essential that employees in the pharmaceutical, biotech, and medical device manufacturing companies ' or related fields ' understand the regulatory environment in which they work. Whether it's for better performance or career development, employees in these industries need to know how and why their products make it to the marketplace ' or how and why they get rejected. What is the FDA? How does it operate? What are the regulations and FDA requirements that must be met in order to manufacture and market a drug or a vaccine'a medical device? What is the process and timetable, and what are the strategies that can be used to get a product to market in the least amount of time? 'your patent is expiring'tick, tick, tick. Finally, what are the risks and costs of non-compliance? Regulatory Affairs is a technical subject. 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 imp

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Lehigh University is accredited by the Middle States Commission on Higher Education.

Credits : 12