21 CFR 111 Dietary Supplement GMP Overview
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?
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: July 18, 2024 & July 19, 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.
Internal Auditing Training for Dietary Supplement
This course is 8-Hours. This dietary supplement internal auditing course will help you understand the fundamentals of auditing and how to conduct an internal audit focused on cGMP and other FDA requirements. The training incorporates internal audit best practices, regulatory requirements and information on turning internal audit findings into useful information. Requirements for 21 CFR 111, supplier programs and FSMA are incorporated into the content.
You’ll learn how to prepare, perform, report and close an audit and discuss the importance of using CAPA systems as a follow-up to your internal audit findings.
Part 1 - October 17, 2024 1:00pm.-5:00pm Eastern Time
Part 2 - October 18, 2024 1:00pm-5:00pm Eastern Time
Cost: $600.00
*Register 3 or more attendees from the same company under the "General Registration" type, 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.
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.