Title: Course Syllabus
Course: PW-Course-Import-Test > Section: Course Introduction

Course Introduction

CONTINUING EDUCATION SYLLABUS

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COURSE: Introduction to Quality Systems (CEMD-0940-CBE)

NAME OF DEPARTMENT: Continuing Education

DEPARTMENT CHAIR:  Jennifer Saunders, Associate Dean

DEPARTMENT CHAIR PHONE NUMBER: 801-957-5303

Name of department: Continuing Education

Department chair:  Jennifer Saunders, Associate Dean

Department chair phone number: 801-957-5303

Name of department: Biotechnology

Department chair: Jean Bower, Program Director

Department chair phone number: 801-957-2851

Instructor's name: David Lockridge

Phone:  385-205-0101

Email: David.Lockridge@fmc-na.com

Consultation Hours:

- Students should check their SLCC Bruin email frequently. The instructor will be using SLCC Bruin school email or Canvas email to contact you. Students should also use their school email or Canvas to contact the instructor.
- The instructor will review emails daily and respond between the hours of 9:00am and 11:00am.

Link For Accessing Online Course Materials:

- The FDA regulations

Textbooks:

21 CFR Combo Parts (801, 803, 806, 807, 809, 810, 812, 814, 820, 821 & 822)

Required equipment, ancillary readings, packets, etc.: Computer with online accessibility.

Course description:

This course introduces the quality system governing the life science industry with emphasis on those that impact medical device development and manufacturing.  A thorough understanding of 21 CFR 820 subparts, an overview of ISO 13485 and quality management system audits will be covered.  Mastery of these core skills is key to successful careers in the medical device and bioscience industry.

Course introduction:

The course is developed 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).  It is focus on the participants’ attainments of industry-recognized credentials to facilitate their employment and career upward mobility.

Medical Device Program Mission Statement:

- Build an industry-driven, high quality, accelerated education and training program
- Focus on the participants’ attainments of industry-recognized credentials to facilitate their employment and career upward mobility
- Establish strong partnerships with local businesses and provide them with skilled workers

Delivery Model:

This course is structured as an asynchronous, fully on-line competency-based learning course. Students may move through the material at their own pace within the parameters of the Continuing Education department, currently within the 8-week block associated with the course. Learning materials and instruction are designed to assist the student to move toward mastery of the concepts and skills that will lead toward the competencies.

Prerequisite: n/a

Student Contribution:

To truly master this content in such an abbreviated session you are encouraged to read all the course materials, view the videos and participate in the online learning community. You can help your fellow students learn by sharing your "real life" examples.

Course Competencies:

Upon successful completion of this course, students are able to:

- Analyze the consequences related to CFR non-compliance of quality systems at a medical device company
- Explain the purpose of design controls with the medical device industry
- Identify key components of good document control requirements within the medical device industry
Explain the purpose of production and process controls with the medical device industry
- Explain the purpose of a CAPA system and how it used in a regulated medical device environment
- Explain the significance of medical device record retention and controls
- Explain the principles and benefits of internal audits at a medical device industry
- Distinguish the key differences between the requirements of 21 CFR820 vs. ISO 13485

Course Requirements:

- Final Objective Exam
- Final Performance Exam

ASSESSMENT PROCEDURES

Module Quizzes

This course is divided into eight Modules with practice assignments and/or quizzes, which support the student’s ability to pass the comprehensive final exams.

FINAL EXAM

After completion of the course, students will take two comprehensive Final Exams:

Objective Exam:  Students take an objective test question exam in the classroom using Lockdown Browser. Phones must be put away.

Performance Exam:  Students will prepare a narrated presentation and submit it through the Canvas site. All class notes, on line references, exercises and materials may be used to accomplish Part 2.

Students may retake the exams one time if a score of 79% or below is scored.

Students must pass both exams with a minimum score of 80%

The online Canvas site includes more detailed information about the exams.

GRADING SCALE AND POLICY

Grade | Percentage of Points
P | 80-100%
F | <79%

COURSE CONTENT

Module# | Topic | Activities
1 | Introduction to the quality system | Narrated PowerPoint, readings, video, learning community discussion
2 | Design Control Systems | Narrated PowerPoint, readings, video, learning community discussion
3 | Document Control | Narrated PowerPoint, readings, video, learning community discussion
4 | 21 CFR 820 Subparts G to I (PP&C) 21 CFR 820 Subparts K, L, N, O | Narrated PowerPoint, readings, video, learning community discussion
5 | 21 CFR 820 Subpart J (CAPA) | Narrated PowerPoint, readings, video, learning community discussion
6 | 21 CFR 820 Subpart M (Records) | Narrated PowerPoint, readings, video, learning community discussion
7 | 21 CFR 820.22 (Internal Audit) | Narrated PowerPoint, readings, video, learning community discussion
8 | ISO 13485 Overview 21 CFR vs. ISO 13485 | Narrated PowerPoint, readings, video, learning community discussion

Articulation Information:

After completion of both CEMD 0930 and 0940, students can receive credit for SLCC BTEC 2035 (2 credits).  These credits count toward a Biotechnology AS or AAS degree.  For more information, please contact Jean Bower 801-957-6337 for more information.

Student Code of Conduct:

The student is expected to follow the SLCC Student Code of Conduct found at http://www.slcc.edu/policies/docs/Student_Code_of_Conduct.pdf.

ADA Statement

http://www.slcc.edu/drc/

Students with medical, psychological, learning or other disabilities desiring accommodations or services under ADA, must contact the Disability Resource Center(DRC). The DRC determines eligibility for and authorizes the provision of these accommodations and services for the college.

Please contact the DRC at the Student Center, Suite244, Redwood Campus, 4600 South. Redwood Rd, 84123. Phone:(801)957-4659,TTY:957-4646,Fax:957-4947or by email: linda.bennett@slcc.edu

Title IX Information:

20 U.S.C.A. Section 1681 (a):  TITLE IX

“No person in the United States shall, on the basis of sex, be excluded from participation in, be denied benefit of, or be subjected to discrimination under any education program or activity receiving federal funds.”

Examples of violations (but not limited to):

- Sexual advances, requests for sexual favors and sexually motivated physical conduct
- Overt or subtle pressure for sexual activity
- Sexually offensive verbalization including remarks, “teasing”, slurs, and innuendo
- Repeated inappropriate jokes or comments about sex or gender specific traits
- Conduct that is demeaning or derisive and occurs substantially because of one’s gender
- Sexual assault
- Sexual Violence
- Gender based disparate treatment

Violations can occur in any college environment, such as (but not limited to):

- Field Trips | - Classrooms
- Student Clubs | - Athletics
- Transportation | - On Campus Events

If you have questions or concerns regarding your rights or responsibilities, or if you would like to file a Title IX complaint please contact:

Students: Dr. Marlin Clark, Dean of Students, 801-957-4776, STC 276 A (Redwood)

Employees or Community members: Ken Stonebrook, Title IX & Discrimination Manager, 801-957-5027, AAB 211G (Redwood)

Online Reporting Form: http://www.slcc.edu/eeo/title-ix/complaint.aspx

Salt Lake Community College has a strong prohibition against RETALIATION!

The college does not tolerate acts of retaliation against anyone for engaging in filing a complaint or participating in an investigation.

You may not record or publish information from the class without written authorized use from the instructor. If used without authorization you have violated PRIVACY/INTELLECTUAL PROPERTY RIGHTS.

Short Term Intensive Training (STIT) Tuition Assistance Policy:

STIT tuition is funded at the end of training when students have shown proof of class attendance and participation with a passing grade. In the event a student fails the course, STIT funding will be removed and the student will be required to pay the STIT portion (50%) of tuition. In addition, the failing grade will impact future ability to receive STIT tuition assistance. In the event a student drops the course after the start date, the student will be required to pay the STIT portion (50%) of tuition.

Refund Policy

A full refund will be issued if course is dropped before 1st day of class.  This course is non-refundable after the lst day of class.  This course is non-refundable for "no-show."  If space is available, you may move to another section.  You may carry tuition to next semester.