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:
- 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:
- Buildings and facilities
- 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:
- Quality control/assurance
- Laboratory operations
- Suppliers and distributors
- Regulatory affairs
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.