GMPs for Dietary Supplements: 21 CFR 111 Subparts E, K, F and J
On-Demand
Course Overview
This self-paced course covers the requirements for specifications and guidance to establish them, which must be in place to ensure compliance with 21 CFR 111. Specifications for components, ingredients and in-process control points are critical to ensure finished product specifications are met.
This module also covers quality control responsibilities, laboratory requirements and guidance for conducting a root cause analysis and implementing effective corrective actions. The following subparts of 21 CFR 111 are reviewed:
- Subpart E – Production and Process Control
- Subpart K – Manufacturing Process Control
- Subpart F – Quality Control
- Subpart J – Laboratory Operations
Additional Recommended Courses
21 CFR 111 Dietary Supplement GMP Overview
This training course is 16-Hours split over 3-days. 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.
As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training on a regular basis.
Course Prerequisites: None
Date: November 13, 2024
Time: 12:00 pm to 5:00 pm Eastern Time
Date: November 14, 2024
Time: 12:00 pm to 5:00 pm Eastern Time
Date: November 15, 2024
Time: 12:00 pm to 6:00 pm Eastern Time
Cost: General Registration $1200.00
*Register 3 or more attendees from the same company and receive a 10% discount off each registration*
Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.
Course log in details will be sent in a separate email. 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.
ISO 22716: Good Manufacturing Practices for Cosmetic and Personal Care Professionals
This course is 8-hours. The ISO 22716 GMP cosmetics training will show you how to identify regulatory non-compliances before they become an issue, minimizing risk while adding measurable value to the manufacturing process. This course has been updated with information from the U.S. FDA's draft guidance for cosmetics manufacturing, U.S. FDA's GMP Inspection Checklist for Cosmetics, and general requirements from the Modernization of Cosmetic Regulations Act (MoCRA) enacted in December 2022.
Learners will understand globally recognized ISO 22716 standards and the U.S. FDA’s draft guidance for cosmetics manufacturing.
This course is geared to those individuals involved in the cosmetics Industry including:
· Marketing
· Quality Control/Assurance
· Packaging
· Manufacturing
· Laboratory Operations
· Suppliers and Distributors
· Auditing
· Regulatory Affairs
· Sales
· Retailers
· Product Development
· Brand Holders
Day 1: June 13, 2024
Day 2: June 14, 2024
Time: 9:00 A.M. to 1:00 P.M. Eastern Time (Both Days)
Cost: $1100.00
Register 3 or more attendees from the same company and receive a 10% discount off each registration
Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification. Course log in details will be sent in a separate email. 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.
Vendor Qualification and Audit Training for Dietary Supplements
Vendor Qualification and Audit Training
Unless you intend to test every shipment of every component for every specification, you must qualify your vendors. But FDA does not provide much guidance on how to qualify vendors. This class is designed for to give people who want to improve quality in their facility and who already have a basic understanding of the Dietary Supplement GMPs, the knowledge and skills necessary to qualify suppliers. Since the evaluation of all types of suppliers often involves auditing, this course will incorporate a fresh look at the process of auditing and the skills and techniques necessary to get the most from these activities. The auditing skills and techniques learned in this course are independent of the type of auditing or the standard being audited. These skills and techniques will be useful when conducting internal audits as well as performing audits of suppliers
Day 1: June 20, 2024 1:00pm.-5:00pm Eastern Time
Day 2: June 21, 2024 1:00pm-5:00pm Eastern Time
Cost: $900.00
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. Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.