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)
- 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:
-
- Quality of Online/Hybrid Course Design assured by:
-
- Industry Standard Quality Rubric; Custom Quality Rubric
- Course Note:
- Intro. to Medical Device
Accessibility
- 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
- Additional License(s):
-
Other - Please see material for licensing information.