CEMD 0940-Introduction to Quality Systems

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.
file CEMD 0940-Introduction to Quality Systems (12 MB)
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Date:
2014-11
Primary Material Type:
Hybrid/Blended Course
Institution:
Salt Lake Community College
Project Name:
c3bc
Funding Source:
TAACCCT Round 2
Subjects:
Medical Device

Industry / Occupation

Industry Partner:
N/A
Industry Sector:
Professional, Scientific, and Technical Services -- Professional, Scientific, and Technical Services (541)
Occupation:
Production Occupations (51-0000)

Education / Instructional Information

Instructional Program:
Science Technologies/Technicians (41)
Credit Type:
  • Other
Credential Type:
  • Certificate
Educational Level of Materials:
  • 1st year Community College or equivalent
Time Required:
24 Hours
Language:
English (United States)
Interactivity Type:
Mix of Active and Presentation.
Quality Note:
Modified QM Model
Quality of Subject Matter was assured by:
  • Participation as an ongoing member of team developing the instructional materials
Quality of Online/Hybrid Course Design assured by:
  • Industry Standard Quality Rubric; Custom Quality Rubric
Course Note:
Intro. to Medical Device

Accessibility

Formal Accessibility Policy:
https://www.slcc.edu/drc/
Accessibility Statement:
https://www.slcc.edu/drc/
Accessibility Evaluation Report:
https://www.slcc.edu/drc/
Accessibility Features:
  • Text Access - Text to Speech
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  • Interactive - Keyboard
  • Interactive - Markup
  • Interactive - Text prompts

Copyright / Licensing

Copyright Owner:
c3bc/SLCC
Primary License:
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
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Other - Please see material for licensing information.
 

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