Objective
To provide trainees with information on GMP requirements for manufacturing of dietary supplements as per the FDA: 21 CFR Part 111.
Learning Outcome
After completing this course, the participants should be knowledgeable about USA FDA current GMPs requirements to ensure the quality, purity and safety of released the dietary supplement products for sale.
who Will Benefit?
1. Regulatory/quality assurance personnel
2. Operational (production) managers
3. Middle-to-senior management
Handout Materials
When the training is conducted On-Site, trainees will be given a binder, containing the training course slides and the exercises materials.
sources (Guidelines)
US Department of Health and Human Services; Food and Drug Administration, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. 21 CFR Part 111, Final rule.
Know your instructor
Dr. Jalal Mokhalalati, B.Sc., M.Sc., Ph.D.
Dr. Mokhalalati holds a Ph.D. degree in the field of human nutrition from University of London. Since his graduation in 1981, he wrote a number of books and scientific papers, and he worked in various countries for different sectors, including teaching at the University of Gaza.
In 2001, Dr. Mokhalalati retired from Abbott Laboratories as the Head of Medical and Regulatory Affairs Department in S. Arabia and started his own consultation office in Canada to serve the food & drug industry in all aspects of establishment licensing (GMPs), and Health Products registration with Health Canada.
Certification
Trainees who participate in this program will receive a “Certificate of Achievement” from QMRS Education Center
Table of Contents
The U.S. FDA Dietary Supplements Current Good Manufacturing Practice (cGMP)
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Part 1: Subparts A-D
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Part 2: Subparts E & F
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Part 3: Subparts G-I
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Part 4: Subparts J-L
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Part 5: Subparts M-P
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Course Completion
Test your Knowledge
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Certificate Requirements
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The Quiz
Download Course
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Course Content in PowerPoint
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LevelExpert
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Total Enrolled3
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Duration12 hours
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Last UpdatedAugust 2, 2023