Combination Products GMP and Regulatory Overview (1.5 hours)

Content
1 module

Difficulty
Basic

Rating

Course Length
90 mins

Instructor
NSF Learning

Price
$299.00

Description

This course provides an overview of the US and EU regulatory framework relative to combination products.  This course will discuss the primary mode of action (PMOA), key stakeholders, and Drug-Device Combination (DDC) product requirements as well as a brief discussion of the regulatory framework for jurisdictions beyond the US and EU. This course is approximately 1.5 hours in length and includes knowledge checks after each topic and a competency assessment. 

 

Objectives

By the end of this course you should be able to: 

  • Define combination products
  • Describe the United States and European Union regulatory framework applicable to combination products
  • Define the primary mode of action of a combination product, and
  • Describe evolving regulations in the EU and their impact on combination products.

Certificate

By completing/passing this course, you will attain the certificate Medical Device Certificate

1.
Combination Products GMP and Regulatory Overview
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Added 8 months ago, by Erik

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4838-5532-9120, v. 1

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