Online Course Online Course Medical Device Certificate Elective Medical Device Certificate Elective Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Supply Chain Controls [3.0 RAC]

3.0 RAC Credits Member: $365 Nonmember: $500
Supply Chain Controls [3.0 RAC]
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 increasing globalized healthcare industry creates regulatory supply chain challenges that may not be addressed in current regulations, which may lag industry best practices. In the US, lawmaking bodies like Congress must put into place legislation that can then 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 guidance and regulations in the area of supply chain (though they may not necessarily use this exact term. Keep in mind that Good Distribution Practice (GDP) is another term to look out for in the context of supply chain integrity.)

This course provides a review of common supply chain issues and addresses how agencies like FDA encourage organizations to improve supply chain controls through guidance documents and regulatory harmonization activities. It also reviews key steps in supply chain control as well as advanced techniques for regulatory affairs/quality assurance executives to consider. After completing this course, you will be well positioned to help guide your organization through 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

Learning Objectives

Upon completion of this course, participants should be able to:
  • Explain various risks and challenges associated with a supply chain
  • Identify helpful 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

Lesson Titles
  • Lesson 1: Overview of Supply Chain Risks
  • Lesson 2: Global Regulatory Harmonization and Guidance
  • Lesson 3: Supplier Risk Management
  • Lesson 4: Advanced Roles of Regulatory Affairs

Enrollment Period: 6 months
Add to Cart
 

Discover more of what matters to you

ComplianceGlobalNorth AmericaSupply Chain Management

News »

  10;16;20;33;