Supply Chain Controls

This course provides a review of common supply chain issues and addresses how agencies like FDA encourage organizations to improve supply chain controls.

A supply chain is a series of linked activities and organizations that transform natural resources, raw materials, components, services and information into a finished product that is then delivered to the end customer.

Supply chain controls are designed to minimize risk to a finished product, from the product’s initial creation in a field or laboratory, to suppliers involved all along the linked activities, through final distribution to the end customer. Whether the risk stems from an original raw ingredient producer or a storage warehouse, the safety and effectiveness of active pharmaceutical ingredients, foods, pharmaceutical and biological products, cosmetics, veterinary products and medical devices can be jeopardized by supply chain challenges. As a result, supply chain controls continue to evolve to meet these rapidly evolving risks.

The increasingly globalized healthcare industry creates regulatory supply chain challenges that may not be addressed by current regulations, which may lag behind industry best practices. In the US, lawmaking bodies, such as the U.S. Congress, must develop legislation that can be enforced by national agencies, such as the US Food and Drug Administration (FDA). A similar situation exists for international regulatory agencies and non-governmental organizations, such as the World Health Organization (WHO) and the Pharmaceutical Inspection Cooperative Scheme (PIC/S). These organizations and authorities regularly issue new and improved supply chain guidance and regulations. Good Distribution Practice (GDP) also promotes methods for attaining supply chain integrity.

With the above considerations, this course provides a review of common supply chain issues and addresses how agencies, such as FDA, can encourage improving supply chain controls through guidance documents and regulatory harmonization activities. The course also reviews key steps in supply chain control as well as advanced techniques for regulatory affairs/quality assurance for company executives to consider. By completing this course, students will be well positioned to help guide an organization through the many supply chain challenges and complexities.

At a Glance

Target Audience: This course is intended for regulatory professionals interested in supply chain management and advanced supplier management controls who have a working knowledge of supplier qualification and management and/or have taken the RAPS Online University Supplier Management course as a precursor.

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

Explain various risks and challenges associated with a supply chain

Identify helpful rules and regulations, global harmonization, and non-governmental organization guidelines

Discuss the elements of the new good distribution practices (GDPs)

Outline various challenges presented by a supplier’s own supply chain

Define the advanced roles of regulatory affairs in supply chain management