Print Version

Effective: Summer 2014

Grade Type: Letter Grade, the student may select Pass/No Pass
Not Repeatable.
FHGE: Non-GE Transferable: CSU
5 hours lecture. (60 hours total per quarter)

Student Learning Outcomes -
  • Students who successfully complete this course should be able to analyze and propose corrective and preventative actions.
  • Students who successfully complete this course should be able to summarize FDA regulations in relation to quality assurance requirements.
Description -
Provides students with an in-depth understanding of the role quality plays in an industrial environment regulated by the Food and Drug Administration (FDA). The responsibilities of quality assurance during the engineering, manufacturing, and production of a product. Topics will include management responsibilities, design control, production and process controls, continuous improvement, and methods and tools used to support quality assurance. The ISO standards, the regulatory requirements mandated by the FDA.

Course Objectives -
The student will be able to:
  1. Summarize the history and provide an overview of the quality of assurance and FDA Regulations
  2. Describe the different management responsibilities
  3. Explain the end-to-end design control
  4. Understand the purchasing processes and controls
  5. Explain the production and process control systems and their relationships
  6. Analyze the corrective and preventative actions
Special Facilities and/or Equipment -

Course Content (Body of knowledge) -
  1. Scope of the Quality Systems Regulations (QSR)
    1. Basic concepts
    2. Traditional vs. total
    3. Approaches
    4. Characteristics
    5. Organizational responsibilities
  2. Explain regulations and standards
    1. FDA history
    2. FDA regulations
    3. ISO history
    4. ISO and FDA regulatory requirements
    5. European Union Medical Device Directives
    6. Global Harmonization Task Force
    7. Quality System Inspection Technique
  3. Management responsibility
    1. Quality policy
    2. Organization
    3. Management representative
    4. Management review
    5. Quality planning
    6. Quality procedures
    7. Quality audits
    8. Personnel and training
  4. Design controls
    1. Design and development planning
    2. Design inputs
    3. Design outputs
    4. Design verification and validation
    5. Design review
    6. Design transfer
    7. Record keeping
  5. Purchasing controls
    1. Supplier evaluation
    2. Supplier control
    3. Recordkeeping
    4. Purchasing data
    5. Incoming inspection activities
  6. Production and Process controls
    1. Production and process changes
    2. Environmental control
    3. Personnel
    4. Contamination control
    5. Buildings
    6. Equipment
    7. Automated process
  7. Process validation
    1. Receiving, in process and finished device acceptance
    2. Nonconforming product
  8. Corrective and preventative action
    1. Device recordkeeping
      1. Device master record
      2. Device history record
    2. Complaint handling
  9. Servicing
    1. Statistical techniques
    2. Configuration Controls
Methods of Evaluation -
  1. Midterm exams comprised of objective and/or written sections and which require critical thinking and analysis of course readings
  2. Final exam requiring knowledge and analysis of all information gathered during the course
  3. Oral presentation
  4. Written expression in evaluating course topics and which require integration of scientific principles with societal/personal views
Representative Text(s) -
  1. Daniel and E. Kimmelman, The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, 2nd edition, 2008. (Latest Edition) ISBN 0873897404
Although this text is older than the suggested "5 years or newer" standard, it still remains a seminal text in this area of study.

Disciplines -
Method of Instruction -
Lecture and group discussion.
Lab Content -
Not applicable.
Types and/or Examples of Required Reading, Writing and Outside of Class Assignments -
  1. Reading Assignments
    1. Weekly reading assignments from text and outside sources
    2. Suggested supplemental readings from articles relevant to course material
    3. Suggested supplemental reading of case studies
    4. Suggested supplemental readings from web searches relevant to course material
    5. Weekly discussions based on reading assignments and which require knowledge and integration of course material
  2. Writing Assignments
    1. Question sets based upon assigned reading on current research topics
    2. Weekly computational problem sets