21 CFR 111 Dietary Supplement GMP Overview

Dates

Times

3 days16-hours VILT

Location

Virtual Learning

Availability

About This Course

FDA expects all companies that manufacture, package or hold dietary supplement products to follow 21 CFR 111, the Dietary Supplement current Good Manufacturing Practices (cGMPs). Combining extensive industry experience and concrete understanding of regulations with flexible and convenient training, this course provides a solid understanding of cGMPs and the responsibilities expected for various individuals and groups within the company. You will learn how to apply cGMP principles to specific situations.

The 21 CFR 111 GMP training 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.

This dietary supplement GMP training course provides an overview of subparts A-P of the 21 CFR 111 regulation, including:

  • Specifications
  • Master manufacturing records/batch production records (MMR/BPR)
  • Quality and FDA authority
  • Warning letters
  • How to make sense of complex regulations in an understandable and comprehensive manner
  • How to effectively convert regulations into real-world examples and scenarios, offering clarity and operational success
  • How regulations can be applied to your organization in a cost-effective manner

Key Learning Objectives

At the end of this course, you will understand the following:

  • Basic requirements of the cGMPs
  • Details of cGMPs as they relate to:
    • Personnel
    • Buildings and facilities
    • Equipment
    • Facility records
    • Production and process control
    • Holding and distribution
    • Batch records
    • Packaging and labeling
    • Quality control and quality assurance
    • Laboratory operations
    • 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.

Who Should Attend?

Attend this training if you work in:

  • Management
  • Manufacturing
  • Quality control/assurance
  • Packaging
  • Marketing
  • Laboratory operations
  • Auditing
  • Suppliers and distributors
  • Regulatory affairs

Instructors

Course instructors will be selected from the following:

Norman Howe - Norman Howe is an experienced quality consultant. Norman has taught a course in quality systems as adjunct faculty at the University of Michigan, Ann Arbor. He serves as an expert witness in FDA-regulated product quality cases.

Previously, Norman was the plant manager of a pharmaceutical plant with BASF and was responsible for manufacturing, quality assurance, engineering, maintenance, contract manufacturing and a small product development group.

Nicole Leitz - Nicole Leitz has more than 20 years of experience in the 21 CFR regulated industries. She has written and presented numerous training sessions on quality system elements and best cGMP practices to corporate clients and at national conventions. Nicole is also an experienced remediation consultant. She has advised, and written documentation such as SOPs and WIs and has completed root cause investigations, CAPAs and complaints for corporate clients.

Nicole has a Master of Science degree in organic chemistry from Bucknell University and a Bachelor of Science in ACS chemistry from Hope College.

Shawn Ludlow - Shawn Ludlow is a well-established NSF GMP instructor. He has created several third-party certified quality programs compliant with 21 CFR 111, ISO 9001:2000 and FAMI–QS.

With an undergraduate degree in chemistry, master’s degree in public health and experience working as an analytical chemist for several years , Shawn found his education and work experience combination to be a natural fit for dietary supplement manufacturers looking to improve their quality programs.

Carlos Alvarez - Carlos Alvarez received a Bachelor of Science in chemical engineering from the University of Puerto Rico and an Master of Business Administration from Rider University in New Jersey. Carlos has more than 25 years of experience, having worked in the food, consumer healthcare, pharmaceutical and dietary supplement industries.

Can’t Attend the Live Course?

We also offer interactive self-paced dietary supplement GMP eLearning covering all subparts of the regulation.
Find out more

Additional Recommended Courses

21 CFR 111 Dietary Supplement GMP Overview Intro

This course provides an overview of 21 cCFR 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 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 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.
Dates: December 5, 2024 & December 6, 2024
Time: 1:00 P.M to 5:00 P.M Eastern Time

Cost: $900.00
Course Prerequisites: None

*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.

Virtual Classroom Training
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.

Virtual Classroom Training
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.

Virtual Classroom Training