Course Syllabus

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SAC LogoMNFG 120 Syllabus

Course Description: 

The course goal is to teach students an overview of quality system regulations and standard compliance used in the medical device industry. The course content will be applicable to the medical technology disciplines of manufacturing, engineering, welding, and biotechnology. This will be placed within a strategic context to generate discussion regarding the importance of quality management and to relate it to other business and organizational issues.

 

Since applications of products in the medical device industry will be reviewed, some material during the lectures, presentations, and related videos may be too graphic for some people.

Textbook Information:  N/A


Additional Course Information:

If you do not have access to a computer please contact me as soon as possible.

 

The web-based sources used in this course include but are not limited to the listed references:

 

American Society for Quality

http://www.asq.org

Baldrige Performance Excellence Program

http://www.nist.gov/baldrige/

International Organization for Standardization

https://www.iso.org/

US Food and Drug Administration

http://www.fda.gov

Quality Digest

http://www.qualitydigest.com

Quality Magazine

http://www.qualitymag.com

Quality Progress

http://asq.org/qualityprogress/


Course Learning Objectives:  

By completing this course, a student will be able to:

 

  • Understand the core elements of the Quality System Regulation (QSR) and ISO 13485 standard.
  • Demonstrate an understanding of the history of quality and the definitions, principles, and critical concepts of quality management.
  • Know the concepts of quality planning and improvement.
  • Understand the strategic importance of Quality Management and its functioning at corporate and operation levels.
  • Have an appreciation of the planning involved in the introduction, management of quality, the leadership, organizational change, and cultural implications of the process.
  • Have the knowledge of applying quality tools and techniques.
  • Know the basic concepts of nonconformance, corrective and preventive actions, and root cause analysis.
  • Understand how to conduct organizational self-assessment and internal quality auditing.
  • Demonstrate an understanding of the quality professional code of ethics.
  • Link and apply contents to manufacturing technology disciplines.
  • Analyze the fundamentals of a quality system as it relates to one or more manufacturing technology disciplines.

 

Meet Your Instructor: 

Bryant Trinh

  • Adjunct Faculty Member at Santa Ana College
  • Manufacturing Engineer

Course Syllabus:  00 - Syllabus - Manf Tech 120 - Introduction to Medical Device Quality - Precourse.pdf

 

Course Summary:

Course Summary:

Date Details Due