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21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General

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About Course

Get a clear introduction to the FDA’s current good manufacturing practice (cGMP) requirements for drugs. This self-paced course covers 21 CFR Part 210, helping you understand its scope, key definitions, and connection to pharmaceutical quality.

Designed for professionals in quality, compliance, manufacturing, and auditing, this course builds a foundation for understanding the requirements that apply to drug manufacturing, processing, packing, and holding. Complete the course and pass the final exam to earn your Certificate of Completion.

What Will You Learn?

  • You will learn the foundational CGMP requirements that govern drug manufacturing, processing, packing, and holding under 21 CFR Part 210.

Course Content

Acknowledgements and Attestation

  • Submit Acknowledgements and Attestation

Sec. 210.1 Status of current good manufacturing practice regulations.

Sec. 210.2 Applicability of current good manufacturing practice regulations.

Sec. 210.3 Definitions.

21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General Final Exam
This final exam is administered to demonstrate the participant’s understanding and comprehension of the course materials. A score of 80% or greater is required to receive a Certificate of Completion.

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