BEC 475/575
Global Regulatory Affairs for Medical Products

Course Description

This course introduces students to the quality systems used to meet the regulatory requirements for developing, testing, manufacturing, and selling medical products in the global marketplace. It provides a general background for all future employees in the medical products field, but is especially useful to students preparing for a career in the Regulatory Affairs or Quality Assurance departments within a pharmaceutical, biomanufacturing, or medical device company.

This is a full semester course with learning materials posted on the course's internet site. The reading assignments use references from regulatory agencies and published case studies to explore quality compliance issues related to regulations published by the United States Food and Drug Administration (FDA) and other international Boards of Health. Weekly activities, an audit exercise, a midterm, and a final exam assess the student’s knowledge of the subject matter.

BEC 475 students can complete the entire course online. BEC 575 students enrolled in the "Hybrid – Online and In-Person" section are required to come on campus to conduct a one-time 3-hour compliance audit of the BTEC facility. BEC 575 students enrolled in the "Distance Education – Online" section can complete the compliance audit (entire class) online.

Lecture Topics

Moodle Topic No.	Learning Modules
1	1.1 - Course Introduction and Medical Products
1	1.2 - Product Life Cycle
2	2.1 - U.S. Food & Drug Administration (FDA)
2	2.2 - Other Regulatory Agencies
3	3.1 - Quality Systems
	3.2 - Risk Management
	3.3 - Product Design/Process Development
4	4.1 - Clinical Trials, CTM Manufacturing
4	4.2 – Facilities
5	5.1 - Utilities
	5.2 - Outsourcing
	5.3 - Equipment Life Cycle, Commissioning
6	6.1 - Facility and Equipment Qualification
	6.2 - Process Validation
	6.3 - Cleaning Validation
7	7.1 - Mid-Term on Topics 1-6
8	8.1 - Components
8	8.2 - Production Systems, PAT
9	9.1 - Documentation
9	9.2 - Training
10	10.1 - Quality Control, Stability
	10.2 - Audits and Evaluation
	10.3 - Regulatory Inspections
11	11.1 - Batch Release
	11.2 - Failure Investigations
	11.3 - CAPA, Change Control
12	12.1 - Regulatory Approvals
12	12.2 - Surveillance
13	13.1 - Final Exam on all topics

Learning Outcomes

At the end of this course, students should be able to:

Describe the life cycle for medical products.
Compare and contrast the regulatory requirements for developing, testing, manufacturing, and selling different types of medical products.
Compare and contrast the regulatory requirements of different markets.
Conduct an audit of a GMP manufacturing facility and document potential compliance issues and corrective actions.

Prerequisites

BEC 475: Senior standing or permission of instructor (with >2 yrs biology and/or chemistry)

BEC 575: Current or future graduate standing

Text Requirements

All reading assignments will be available on the course website or other internet websites (especially the US FDA website).

Content

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