PLST2030 Systematic Medical Device Protocol

This course introduces students to the concepts, principles and specific requirements regarding Food and Drug Administration (FDA) and Good Manufacturing Practices (GMP) that strictly regulate how organizations must adhere to a systematic approach to the production of medical devices.

Credits

3

Prerequisite

Instructors approval

Course Requirements and Evaluation

Refer to Course Syllabus for detailed information regarding the requirements and evaluation standards for this course. The Course Syllabus will be distributed the first week of the course.

Learning Outcomes

The following outcomes will be addressed in the course:
Identify quality system regulations
Identify with quality systems
Identify with design controls
Identify with process validation
Identify with equipment and calibration
Complete device master records
Determine document change control
Analyze product evaluations
Show awareness of quality system audits
Show awareness of factory inspections

Text and References

A list of textbooks required for this course is available at the bookstore.

Course Scheduling

The scheduled hours of instruction include sixteen hours for each lecture credit, thirty two hours for each lab credit and forty hours for each credit of supervised occupational experience (SOE). Lecture credit may include formal or impromptu lectures, demonstrations or discussions with the entire class or with small groups or individuals. Refer to the Credit Details section of this course outline for the credit breakdown.

Accommodations Statement

Disability Services assists students with disabilities who need accommodations to access programs, services and college activities.  If this applies to you, please contact the DS Office on your campus to initiate the accommodations process. 
Brooklyn Park Campus - 763-488-2477
Eden Prairie Campus – 952-995-1544

Campus

Brooklyn Park Campus 952-995-1300

Credit Details

lecture:

2

lab:

1