CEMD 0940-Introduction to Quality Systems
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Keywords
Medical Device
Project
c3bc
Authors
Bolander, Jennifer
Lockridge, David
Ngan-Winward, Vivian
Date Submitted
2014-11
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 quality system governing the life science industry with emphasis on those that impact medical device development and manufacturing. A thorough understanding of 21 CFR 820 subparts, an overview of ISO 13485 and quality management system audits will be covered. Mastery of these core skills is key to successful careers in the medical device and bioscience industry. The course will be taught through lectures using a hands-on approach in conjunction with class discussions. In addition, student will apply their computer skills, particularly with Microsoft Word and Excel to 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