Supplier Management
Supplier management—also known as “vendor management”—is a term encompassing a broad array of regulatory requirements and industry activities necessary to develop, manage and control active pharmaceutical ingredients, foods, pharmaceutical and biological products, cosmetics, veterinary products and medical devices. US Food and Drug Administration (FDA) regulations and guidance documents help ensure that such products are consistently developed, produced, distributed and otherwise controlled according to quality standards whenever suppliers are involved. Most regulatory agencies and nongovernmental organizations (NGOs) around the world embrace similar regulations and guidelines as a core requirement of doing business in today’s global marketplace.
This course provides a basic understanding of current supplier management practices and their impact on product quality and patient safety. It covers a wide range of issues, including why regulations and guidance documents targeting supplier oversight are increasing in rigor; how companies ensure compliance; what are the basic roles and responsibilities of regulatory and quality professionals; and which are the most common regulatory issues stemming from poor supplier performance and weak supplier management. This course will help you understand the key risks associated with suppliers and how best to help your organization as a regulatory professional.
At a Glance
- Target Audience: This course is for regulatory professionals interested in basic supplier management, qualification and oversight activities.
- Learning Level: Basic
- Total Length of Course: 3 Hours
- RAC Points: 3
- Medical Device Certificate Elective
- Pharmaceutical Certificate Elective
- Enrollment Period: 12 months
Learning Objectives
Upon completion of this course, participants should be able to:
- Define terms and understand concepts of supplier management
- Describe the different regulatory issues arising from supplier management
- Identify the elements of supplier management
- Outline how to qualify and manage a supplier
- Explain the roles of regulatory, quality, and other functional business activities
Lesson Titles
- Lesson 1: Key Concepts
- Lesson 2: Regulatory Issues Associated with Suppliers
- Lesson 3: Elements of Supplier Management
- Lesson 4: Basic Roles and Responsibilities
This course is also included in:
Certificate in Pharmaceutical Regulations
Certificate in Medical Devices Regulations
Certificate in Medical Devices and Pharmaceuticals Regulations
