GMPs for Dietary Supplements: 21 CFR 111 Comprehensive Overview

About This Course

This self-paced course provides a comprehensive overview of 21 CFR 111 - Current Good Manufacturing Practices (cGMPs) for Dietary Supplements. Comprised of four modules and a final assessment, this course includes an introduction to cGMPs, required product quality elements, documentation and investigations, and an overview of the 21 CFR 111 subparts.

The 21 CFR 111 training also reviews the proper way to execute GMP records, details personal hygiene requirements, examines the meaning of master and batch records for control of production, labeling and packaging, clarifies quality requirements, and describes the purpose of GMP rules, regulations and FDA enforcement.

As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training regularly.

Course Outline

Module One of this course covers the following requirements of 21 CFR 111:

  • Subpart A – General Provisions
  • Subpart P – Records and Recordkeeping
  • Subpart H – Master Manufacturing Records
  • Subpart I – Batch Production Record

Module Two of this course covers the following requirements of 21 CFR 111:

  • Subpart B – Personnel
  • Subpart C – Plants and Grounds
  • Subpart D – Equipment and Utensils

Module Three of this course covers the following requirements of 21 CFR 111:

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

Module Four of this course covers the following requirements of 21 CFR 111:

  • Subpart G – Components, Packaging, and Label Control
  • Subpart L – Packaging and Labeling Control System
  • Subpart M – Holding and Distributing
  • Subpart N – Returns
  • Subpart O – Complaints
  • The Role of the FDA and its Authority

The course also includes a final competency assessment module.

Pricing: $1399.00 — Save over $500 by purchasing the bundle.

Modules can also be purchased as stand-alone courses.