Master the competencies related to the regulation of medical device quality systems. In particular, students will be able to describe regulations 21 CFR 820 ISO1345 and explain the consequence of noncompliance to the company and its employees. Students will demonstrate the ability to assess situations of noncompliance and analyze the effects on the company. This course introduces the concept of a quality system, system structure, and its relevance to the medical device and life science industry. Individuals will understand proper setup and operation of a quality system, including the FDA-required Good Manufacturing Practices (GMP).
Medical Device Manufacturing: Processes & Practices
The Medical Device Manufacturing: Processes and Practices certificate program includes a series of courses addressing the competencies outlined by the medical device industry and covers basic core knowledge and skills required for entry-level positions. Each course content aligns with national industry-recognized standards. A core knowledge and skills certificate will be awarded upon the successful completion.
This training is appropriate for those new to the industry, transitioning from a related discipline or professionals wanting refresher courses.
Course
Title
Prerequisite
Course CEMD 0910
Title Intro Medical Device Industry
Prerequisite
Description
This course provides an overview of the medical device industry, particularly in Utah. It will address topics including diversity of products, size and scope of the industry, current trends, and the product life cycle from conception to market approval and distribution.
Section List
CEMD 0910-002
CRN:
45863
Course Type:
Lecture
Semester:
Fall
Dates:
Sept. 23 - Nov. 11
Days:
Monday
Time:
6-9 p.m.
Credits/Contact Hours:
24
Campus:
Miller Campus
Amount:
$299.00
Call 801-957-5200 to register
Course CEMD 0920
Title Basic Manufacturing Skills
Prerequisite
Description
This course focuses on fundamental principles of measurement, performing measurements, data management and analysis related to medical device manufacturing. Mastery of these skills is key to successful careers in the medical device and bioscience industry.
Section List
CEMD 0920-002
CRN:
45955
Course Type:
Lecture
Semester:
Fall
Dates:
Sept. 26 - Nov. 14
Days:
Thursday
Time:
6-9 p.m.
Credits/Contact Hours:
24
Campus:
Westpointe Center
Amount:
$299.00
Call 801-957-5200 to Register
Course CEMD 0930
Title Intro to FDA Regulations
Prerequisite
Description
This course introduces the regulations governing the life science industry with emphasis on those that impact medical device development and manufacturing. A thorough understanding of FDA regulations and an overview of equivalent international regulations will be covered.
Section List
CEMD 0930-001
CRN:
32459
Course Type:
Lecture
Semester:
Fall
Dates:
July 30 - Sept. 17
Days:
Tuesday
Time:
6 - 9 p.m.
Credits/Contact Hours:
24
Campus:
South City Campus
Amount:
$299.00
Call 801-957-5200 to Register
Course CEMD 0940
Title Intro to Quality Systems
Prerequisite
Description
Section List
CEMD 0940-003
CRN:
45850
Course Type:
Lecture/Lab
Semester:
Fall
Dates:
Aug. 1 - Sept. 19
Days:
Thursday
Time:
6 -9 p.m.
Credits/Contact Hours:
24
Campus:
Miller Campus
Building Room:
MFEC 209
Amount:
$320.50
Call 801-957-5200 to Register
Course CEMD 0940
Title Intro to Quality Systems - ONLINE
Prerequisite
Description Master the competencies related to the regulation of medical device quality systems. In particular, students will be able to describe regulations 21 CFR 820 ISO1345 and explain the consequence of noncompliance to the company and its employees. Students will demonstrate the ability to assess situations of noncompliance and analyze the effects on the company. This course introduces the concept of a quality system, system structure, and its relevance to the medical device and life science industry. Individuals will understand proper setup and operation of a quality system, including the FDA-required Good Manufacturing Practices (GMP).
Section List
CEMD 0940-001
CRN:
45856
Course Type:
Online
Semester:
Fall
Dates:
Sept. 23 - Nov. 11
Credits/Contact Hours:
24
Campus:
SLCC Online
Amount:
$320.50
Call 801-957-5200 to register
Course CEMD 0950
Title Intro to Quality Control - ONLINE
Prerequisite
Description
This course explores the concepts and tools used by quality control technicians in the life sciences including medical devices, pharmaceuticals and nutritional supplements. A broad overview of quality control concepts will be supplemented by 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). Mastery of this knowledge is key to successful careers in quality control, and the context is specifically focused on medical device quality control. 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 Microsoft Excel to effectively use quality tools and descriptive writing skills.
Section List
CEMD 0950-001
CRN:
45959
Course Type:
Online
Semester:
Fall
Dates:
Sept. 23 - Nov. 11
Credits/Contact Hours:
24
Campus:
SLCC Online
Amount:
$320.50
Call 801-957-5200 to Register
Course CEMD 0960
Title QA Auditing Concepts
Prerequisite
Description
This course is an introduction to the field of auditing concepts. Students will gain a basic foundational knowledge to quality auditing in the medical device industry. This course will explore standards and regulations from an auditor’s perspective. Learn the audit program structure, auditing planning, audit performance, audit reporting and action plans. Techniques and tools for conducting a successful quality audit. This course is designed for someone who may be new to auditing in the Medical Device industry or participating as a team member (and/or) interact with audits.
Section List
CEMD 0960-001
CRN:
TBD
Instructor:
Buckingham, Kevin
Course Type:
Lecture
Semester:
Fall
Dates:
Aug. 20 - Sept. 24
Days:
Tuesday
Time:
6 - 9 p.m.
Credits/Contact Hours:
18
Campus:
South City Campus
Building Room:
TBD
Amount:
$199.00
Call 801-957-5200 to Register
Short Term Intensive Training (STIT) funding is available for this course. Contact Kay Carter at kay.carter@slcc.edu or 801-957-5373 to determine eligibility.
Participants who successfully complete the 96 hours of training can earn the Medical Device Core Knowledge and Skills Certificate. The following foundational courses must be completed with a passing grade:
- CEMD 0910 - Introduction to Medical Device Industry
- CEMD 0920 - Basic Manufacturing Skills
- CEMD 0930 - Introduction to FDA Regulations
- CEMD 0940 - Introduction to Quality Systems
Participants completing individual courses to meet FDA compliance training requirements may request letters of completion for personnel files.
These courses are noncredit, however, there is a credit pathway that has been established. After completion of both CEMD 0910 and CEMD 0920, students can receive credit for SLCC BTEC 1025 (3 credits). After completion of both CEMD 0930 and 0940, students can receive credit for SLCC BTEC 2035 (2 credits).
Call 801-957-5200 to register. For STIT funding assistance, participants must first be approved before registering for classes. Contact Kay Carter kay.carter@slcc.edu or 801-957-5373 to determine eligibility.
These foundational courses provide the basic knowledge and skills required for individuals to gain entry-level positions in the medical device industry.
No, SLCC application for admission is not required.
This is a non-credit course. In order to receive a tuition refund, the course must be dropped 24 hours before the course start date. No refund will be issued after the start date.