21 CFR 111 Dietary Supplement GMP Overview Intro: 2 Part Instructor Led Q&C Training Event
May 9 – 10, 2023
This course is 8-Hours. 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 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.
Day: 1 May 9, 2023 1:00 P.M to 5:00 P.M Eastern Time
Day: 2 May 10, 2023 1:00 P.M to 5:00 P.M Eastern Time
Certificate of attendance will be issued upon completion of the course Completion of the course means being in attendance 95% of the log in time. Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.