21 CFR Part 111: Dietary and Food Supplement cGMP

If you’re responsible for manufacturing, packaging, labeling, or distributing dietary supplements, you play a key role in ensuring product quality and regulatory compliance. This course was designed for professionals like you who need a clear, practical understanding of 21 CFR Part 111 (cGMP for Dietary Supplements) and how it applies to real-world operations.

Developed by life sciences and quality management experts, this interactive course combines real-world examples, case studies, and scenario-based learning to make regulations easy to understand and apply. Whether you work in manufacturing, packaging, labeling, or quality control, you’ll gain the knowledge and confidence to meet FDA expectations and strengthen compliance across your organization.

This course covers all key aspects of 21 CFR Part 111 cGMP for dietary supplements, helping professionals ensure product quality, compliance, and inspection readiness.

Who should enroll?

• Quality Assurance (QA) and Quality Control (QC) specialists
• Regulatory Affairs and Compliance officers
• Production and operations managers
• Packaging and labeling supervisors
• Laboratory and process technicians
• Anyone responsible for ensuring product quality and FDA compliance in dietary supplement operations

 
What you’ll learn?

• Understand the scope and regulatory applicability of 21 CFR Part 111
• Implement cGMP requirements for personnel, facilities, equipment, and operations
• Develop and maintain effective production and process control systems
• Ensure compliant packaging, labeling, and documentation practices
• Manage holding, distribution, returns, and complaints of dietary supplements

By the end of this course, learners will have the knowledge and confidence to ensure dietary supplement operations are fully compliant with 21 CFR Part 111. Upon successful completion, you will receive a validated certificate accredited with CPD/CEU credits and recognized by auditors.

Curriculum

Introduction

Lesson 1: General Provisions

Lesson 2: Personal Requirements

Lesson 3: Physical Plant and Grounds

Lesson 4: Equipment and Utensils

Lesson 5: Establishing Production and Process Control System

Lesson 6: Managing Packaging, Labels, and Documenting Operations

Lesson 7: Subparts J, K, and L

Lesson 8 Holding and Distribution

Lesson 9: Returned Dietary Supplements

Lesson 10: Product Complaints

Glossary

Conclusion

Quiz