Certificate in Regulatory Affairs in a Technical Environment
The CRATE program at Lehigh, a master’s-level program, was developed for students working in the pharmaceutical industry who deal with FDA regulations, policy, and protocol. The program gives a foundation of the Regulatory Affairs environment which includes regulations, risks of noncompliance, and timetables and strategies to get products from development to testing to the market as quickly as possible. Students with this degree find they are better prepared for their jobs and, thus, may find career advancements opportunity as a result.
This technical certificate requires students to take 12 credits of courses. Courses include Discovery to Approval, Biomarkers, Validation, Commercial Production, Biologics, and a Chemistry Lab to Clinical Trial experience. Each course is three credits, and students can choose any four courses in any order, pending their availability. Detailed descriptions for each course can be found on the program’s webpage.
Students have the option of choosing between a credit track and a noncredit track. Students who choose the credit track will need to be accepted into Lehigh’s course and will gain master’s-level credits on their transcript in addition to their certificate. This track also enables students to use those credits toward Lehigh’s Masters in Chemistry, should they choose. The credit track requires students to turn in work for grades as well as take proctored exams. Those who choose the non-credit route will be given their certificate at the end of the course with no credit given and are not required to turn in assignments for grades or take course examinations.
As a technical program, students are encouraged to have a background in chemistry that includes experience in analytical chemistry, organic chemistry, and biochemistry.
Degree Level: Certificate
Delivery Format: 100% Online
Accreditation & Licensing
Middle States Commission on Higher Education
Students should possess a background in principles of analytical chemistry, two semesters of organic chemistry, and one semester of biochemistry
Lehigh University was founded in 1865 by industrialist Asa Packer as a technical school for boys focusing on mathematics and science. Today, the co-educational, private not-for-profit University is located in Bethlehem, Pennsylvania on over 2,300 acres. Lehigh University confers degrees through four colleges:
- College of Arts and Sciences
- College of Business and Economics
- P.C. Rossin College of Engineering and Applied Science
- College of Education
Since the turn of the twenty-first century, Lehigh University has offered distance learning for select graduate programs and certificates. These online graduate-level programs give educational options to working professionals and meet the same standards as on-campus programs.
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