Course Description

Introduction to Combination Products in the US

Course Description:

This course examines the historical and legislative perspectives that led to the definition and regulation of combination products in the US, including the establishment of the Office of Combination Products (OCP).

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Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Comprehend the evolution and organization of the regulation of combination products in the US
  • Understand the definitions and classifications of US combination products
  • Recognize the legislative authority of the OCP and its role

Who Should Enroll:

Regulatory Affairs Associate, Regulatory Affairs Manager, Quality Assurance Associate, Quality Assurance Manager, Quality Assurance Engineer, Manufacturing Engineer, Supply Manager, Purchasing Manager, Design Engineer, Validation Engineer, Electrical Safety Engineer, Internal Auditor, Lead auditor, Pre-Clinical Study Manager, Export Manager, Clinical Affairs Director, and R&D Engineer are all welcome to participate in this course.

Prerequisite Knowledge/Requirements:

Individuals taking this course should have a basic understanding of US Food and Drug legislation and regulation.

The following pre-requisite knowledge is required:

  • Introduction to the US FDA (ID 76)

Subject Matter Expert:
Lee Leichter

62 min

Release date:

Related resources:

Case studies:

Basic Account: € 242.00
Premium Account: € 182.00

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