21 CFR 111 Dietary Supplement GMP Overview Remote Training

Virtual Learning

November 10 – 19, 2020

Course Overview

DS - 21 CFR 111 Dietary Supplement CGMP Overview Remote Training
FDA expects all companies that manufacture, package, or hold dietary supplement products to follow 21 CFR 111, the Dietary Supplement CGMPs. This course provides a basic understanding of CGMPs and the responsibilities expected for various individuals and groups within the company. Participants will learn how to apply CGMP principles to specific situations. The course is interactive, with hands-on exercises including case-studies from recent Warning Letters. Bring your questions and prepare to interact with the instructor and your peers in the industry
Course Outline
At the conclusion of the course participants will have an understanding of the following:
· Basic requirements of the CGMPs.
· Details of CGMPs as they relate to:
o Personnel
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 purpose of “Guidance Documents”
· 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. A Certificate of Attendance will be provided upon completion of the course.
This training is being presented remotely, and will be presented in six (2.5 hour) sessions over a two week period.
Week 1
November 10, 2020 - 1:00 pm to 3:30 pm Eastern Time
November 11, 2020 - 1:00 pm to 3:30 pm Eastern Time
November 12, 2020 - 1:00 pm to 3:30 pm Eastern Time

Week 2
November 17, 2020- 1:00 pm to 3:30 pm Eastern Time
November 19, 2020
- 1:00 pm to 3:30 pm Eastern Time
November 20, 2020
- 1:00 pm to 3:30 pm Eastern Time
Cost: General Registration $1500.00
Cost: NSF GMP Clients $1100.00
Course Prerequisites: None