CEMD 0930-Introduction to FDA Regulations
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Keywords
Medical Device
Project
c3bc
Authors
Brown, Jeffery
Ngan-Winward, Vivian
Date Submitted
2014-10
Material Type
Hybrid/Blended Course
Secondary Material Type
Institution
Salt Lake Community College
Industry Partner
N/A
License
CC BY
Funding Source
TAACCCT Round 2
Additional Public Access
Abstract
This course introduces the regulations governing the life science industry with emphasis on U.S. regulations that impact medical device development and manufacturing. A thorough examination of FDA regulations and an overview of equivalent international regulations will be covered. Mastery of this knowledge is key to successful careers in the medical device and bio-science industry. This content will be taught using a hands-on approach in conjunction with class discussions. In addition, students will apply their computer skills, particularly with Microsoft Word and PowerPoint to further develop effective technical writing and communication skills.
Industry (NAISC)
Professional, Scientific, and Technical Services -- Professional, Scientific, and Technical Services (541)
Occupation (SOC)
Production Occupations (51-0000)
Instructional Program (CIP)
Science Technologies/Technicians (41)
Credit Type
Credential Type
Certificate
Educational Level
1st year Community College or equivalent