LESN Online > Certificate in Regulatory Affairs

Program Overview

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? (Hint - they're huge!)

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 impurity profiles of the drug substances.

This masters-level certificate program has been developed for 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. Students will gain a general understanding of the Regulatory Affairs environment, a broader understanding of the FDA and how it works, 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, timetable and strategies used to get a product to market.

Available in a certificate program format and now entirely online (interactive satellite broadcast of courses will be scheduled occasionally for participation at LESN partner sites), Lehigh University provides you with the tools you need to be successful with our Certificate in Regulatory Affairs in a Technical Environment.

Courses

Students will take any 12 credits from the following courses to complete either the credit or professional continuing education certificate requirements.  [NOTE: No course may be applied to more than one certificate].

*Chemistry 425 Regulatory Affairs I: – Discovery to Approval
*Chemistry 428 Regulatory Affairs II: – Medical Devices and Combination Technologies
Chemistry 442 Regulatory Affairs III: – Validation of Analytical Assays
Chemistry 463 Regulatory Affairs IV: – Commercial Production, Validation, and Process Qualification
Chemistry 474 Regulatory Affairs V: – Pharmaceutics

*Note: Either of these courses is suggested as a starting point in the program.

• Prospective students wishing to pursue this certificate for credit will apply for Non- Degree admission that is intended for applicants wishing to take up to twelve credit hours of graduate-level study without seeking a degree.
• Students may begin the courses at the start of any semester period – Summer/Fall/Spring   Please refer to Chemistry Admission Deadlines.
• Course are offered in a semester-based timeframe
• There is no residency requirement
• Students taking courses for credit are responsible for arranging for an independent proctor for examinations. Proctoring may be done by an employee of an academic institution or library, or by HR or other company official. The proctor may not be related to or affiliated with the student in any way. Proctoring eligibility will be verified by Lehigh's Office of Distance Education.

This certificate program is available either for Credit or Professional Continuing Education participation. Choose the learning option you prefer based on your career needs and academic goals. Lehigh University’s commitment to academic excellence ensures your education experience will prepare you for the challenges you face in today’s dynamic work environment.

Program Advisor: Professor Rebecca Miller, 610-758-3676 or e-mail at rsm4@lehigh.edu.