Quality Systems for Regulatory Compliance
Learning Objective:The course employs the learning strategies of reading, writing and discussing. A student who successfully fulfills the course requirements will have demonstrated a functional understanding of regulatory compliance for biomedical devices.
Course runs Mod 2 & 3: June 10 - July 30.
Medical devices are developed and manufactured in a highly regulated environment. This course will provide an introduction, overview, and systematic study of the intent and impact of the major federal laws and regulations governing the development, manufacturing, distribution, and marketing of medical devices. Focus is on understanding the critical elements of regulatory science and quality compliance from a design control perspective. Instruction and mentoring in regulatory science skills is provided by academics and industry representatives with expertise in their fields. This course is part of a three-course series. Summer 2017 Syllabus
Topics Covered:-Intent and impact of the major federal laws and regulations governing the development, manufacturing, distribution, and marketing of medical devices -21 CFR Part 820 Quality Systems Regulation of the FDA -Critical elements of regulatory science and use of quality systems for compliance from a design control perspective -Introduction of CAPAs and data collection for a CAPA -Risk management as a foundation for decision making
Applied / Theory:80 / 20
Web Content:Grades, lecture notes, homework assignments, quizzes, and message board.
Homework:Grading is based on submission of a video bio (10%); discussion question submission (15%), online quizzes (15%); mid-term exams (20%); reflection paper (20%); and exam (20%)
Projects:The format for the 3 to 4-page paper will be described in more detail in the course content. You can also find notes about it at the end of the Schedule/Assignments document. Each assignment is worth a point value and total accumulated points will determine the course grade.
Exams:Quizzes, taken online in Blackboard Learn (no need for a proctor), will be in a 30-min format. Mid-term and final exam
Textbooks:Official textbook information is now listed in the Schedule of Classes. NOTE: Textbook information is subject to be changed at any time at the discretion of the faculty member. If you have questions or concerns please contact the academic department.
Required: "The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices" by A. Daniel and E. Kimmelman, Second Edition. ASQC Quality Press Milwaukee, WI. Additional class reading documents to be provided via Blackboard Learn.