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GMPs for Dietary Supplements: 21 CFR 111 Subparts E, K, F and J

About This Course

This self-paced course covers the requirements for specifications and guidance to establish them, which must be in place to ensure compliance with 21 CFR 111. Specifications for components, ingredients and in-process control points are critical to ensure finished product specifications are met.

This module also covers quality control responsibilities, laboratory requirements and guidance for conducting a root cause analysis and implementing effective corrective actions. The following subparts of 21 CFR 111 are reviewed:

  • Subpart E – Production and Process Control
  • Subpart K – Manufacturing Process Control
  • Subpart F – Quality Control
  • Subpart J – Laboratory Operations

Key Learning Objectives

By the end of this module, you will gain knowledge of:

  • Where specifications are required and how to establish them.
  • How to determine if specification requirements are met.
  • The required content for a certificate of analysis (COA).
  • How to address out-of-specification raw materials and finished products.
  • How to prevent contamination.
  • How to determine the root cause of a problem.
  • The written procedures, documents, and records required to be compliant with the requirements of subparts E, K, F and J.

Pricing: $300.00