CEMD 0930-Introduction to FDA Regulations

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.
Date:
2014-10
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:
  • None
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:
  • Other
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
  • Text Adjust - Compatible
  • Text Adjustment - Adjust Font and Colors
  • Reading Layout - Reflow the Text
  • Reading Layout - Page numbers match printed material
  • Reading Layout - Reflow the Text
  • Reading Order - Digital resource layout
  • Structural Markup - Navigation Text
  • Structural Markup - Lists
  • Structural Markup - eReader application
  • Table Markup
  • Hyperlinks Rendered As Active
  • Colors Compatible With Assistive Technology
  • Contrast Ratio of at Least 4.5:1.
  • Language - Markup
  • Language - Passage Markup
  • Non-Decorative Images Have Alt Text
  • Decorative Images Marked With Null Alt Text
  • Complex Images, Charts, and Graphs Have Text Descriptions
  • Synchronized Text Track
  • Transcript Provided With Audio Content
  • Audio/Video Delivered Via Media Player
  • Non Flickering Content
  • STEM Content (e.g. Mathematics, Chemistry) Markup
  • STEM - Notation markup
  • 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.
Additional License(s):
Other - Please see material for licensing information.