Title: About this Course
Course: PW-Course-Import-Test > Section: Course Introduction

This course explores the concepts and tools used by quality control technicians in the life sciences including medical devices, pharmaceutics and nutritional supplements. You will explore a broad overview of quality control concepts and the standards and tools used by quality control technicians for inspection, calibration, and proper follow up within the requirements of current Good Manufacturing Practices (cGMP).

You will perform quality control activities which includes reviewing requirements (drawings, blueprints) to determine measurement requirements, successfully selecting sampling plans, performing measurement or monitoring measurement reports, determining whether a device meets acceptance criteria, and what to do if an item does not, and writing up a non-conformance report to document a non-conforming inspection.

The course is based upon medical device industry recognized knowledge & skill standards. It is funded by a Department of Labor (DOL) TAACCCT grant for the Community College Consortium for Bioscience Credential (c3bc) and is focused on the participants’ attaining industry-recognized credentials to facilitate their employment and career upward mobility.

Delivery Model

This course is a fully online competency-based learning course. The course is asynchronous, meaning students enter and leave the course at different times. It is self-paced, so you may move through the material at your own pace on your own timetable within the parameters of the department. Learning materials and instruction are designed to assist you toward mastery of the concepts and skills that will lead toward the competencies.

Course Competencies

Upon successful completion of this course, you will be able to:

- Identify quality concepts and principles
- Recognize quality concepts
- Review specifications to determine acceptance criteria
- Identify appropriate statistical sample size as indicated by the drawings or ANSI chart
- Describe Calibration in quality control
- Perform inspection or review reports to determine acceptability of samples or reports
- Determine appropriate action when parts do not meet acceptance criteria
- Assist quality investigator in preliminary investigation

How This Course is Organized

The course is divided into seven modules (units) in addition to this introduction. The modules are sequenced so you learn concepts and practice activities for the targeted competency and prepare to move on to the next competency in the next module. You can visit or revisit any module at any time. If you find that you are comfortable with your ability in one competency, you can move on without completing all activities. Keep in mind that the final objective exam and performance exam at the end of the course will assess your knowledge and ability related to all competencies in the course.

Each module includes videos, articles, examples, and links to resources and websites explaining the major concepts and one or more practice quizzes and learning community discussions. We encourage you to take the practice quizzes and participate in the discussions, but they are not required.

The Learning Community Discussions will help you synthesize and gain a deeper understanding of the material. Read the Learning Community question prompt carefully and then post your answer or comment. You must post first before you can see other students’ comments and/or reply to their posts.

The short Practice Quizzes will help you check your understanding of key concepts. For each question, you will be instructed to either select the one correct answer or select all correct answers, so pay special attention to each question instructions.

Be sure to read the syllabus for all details about this course.

Final Exams

You will complete two exams at the end of the course:

Objective Exam: A multiple-choice, computer-scored exam. You will take this exam in the Salt Lake Community College Testing Center at the Redwood Campus.

Performance Exam: You will perform a quality inspection on medical device components in a lab at Salt Lake Community College Redwood Campus.

You will find instructions for arranging for the final assessments in the Assessment module in Canvas.

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