I. Course Overview

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Course Outline | Objectives | Intended Audience

 

Course Outline:

  • Legal basis for CGMP
  • CGMP legal principles
  • CGMP implementation tools
  • Overview of CGMP requirements
  • CGMP Resources, and
  • Revised Drug Manufacturing Inspections Compliance Program
 

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Objectives:

Upon completion of this course, you will be able to:

  • Describe the legal principles of CGMP including what constitutes non-compliance, the legal scope of inspections, and exclusions from CGMP.

  • Identify CGMP implementation tools.

  • Discuss the status and applicability of the CGMP regulations, as well as define key terms contained in the regulations.

  • Explain what the Division of Manufacturing Product Quality (DMPQ) of FDA will evaluate at a manufacturing site.

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Intended Audience:

This course is intended for professionals and operating technicians in either the FDA or the pharmaceutical industry whose responsibilities are in a manufacturing setting including:

  • Chemists

  • Engineers

  • Plant Operators and technicians

  • Quality Control Specialists

  • New FDA Investigators

  • FDA Reviewers, and

  • FDA Project Managers

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