21 CFR 111 Dietary Supplement CGMP Overview
This course provides an overview of 21 CFR 111, the Dietary Supplement CGMPs. This abridged course includes an introduction to current good manufacturing practices (cGMPs), required product quality elements, documentation, investigations and a brief overview of the relevant subparts. We will also review the proper way to execute GMP records, detail the personal hygiene requirements, examine the meaning of master and batch records for control of production, labeling and packaging, clarify the requirements of quality and, describe the purpose of GMP rules, regulations and FDA enforcement.
o Buildings and Facilities
o Equipment o Facility Records
o Production and Process Control
o Holding and Distribution
o Batch Records
o Packaging and Labeling
o Quality Control and Quality Assurance
o Laboratory Operations o Product Complaints ·
The role of the FDA and their authority
The roles and responsibilities of the Quality Unit
As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training on a regular basis.
Instructor: Shawn Ludlow
Once you've completed your registration, you will have access to the recording for 15 days.
Please note PDF's of the presentation will not be available.
Certificate of participation are not issued for recorded courses.
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