OFFICIAL GMP TRAINING PROGRAM

Connect with leading good manufacturing practice (GMP) experts and get the latest critical learnings that will elevate your business. We've teamed up with NSF International to offer training courses on some of the most important issues facing the global health & nutrition industry.

Separate registration is required for all courses. NSF produces the only GMP Training that is officially sanctioned by SupplySide West. When developing your SupplySide West plans and registering for events, please be cautious of organizations offering similar courses that are not connected to SupplySide West.


21 CFR 111 Dietary Supplement GMP Overview (Two-Part Training)

Monday, September 25 - Tuesday, September 26 | 8am-5pm

Attend an extensive 2-day training course on 21 CFR 111, the current Good Manufacturing Practices (cGMPs) in manufacturing and packaging, labeling or holding operations for dietary supplements. This course is geared to those individuals involved in the dietary supplement industry including:

  • Manufacturing
  • Management
  • Packaging and Labeling
  • Suppliers and Distributors
  • Other Technical Professionals
  • Quality Control/Quality Assurance
  • Laboratory Operations
  • Auditing
  • Regulatory Affairs and Compliance

These guidelines are intended to be applicable to dietary supplements as defined and covered by 21 CFR 111, but may also be applied to dietary ingredients and other components. The course provides an in-depth review of the regulation and provides case studies to review recent FDA Warning Letters initiated to dietary supplement companies for non-compliance with 21 CFR 111 GMPs.


SOP and Record Keeping

Monday, September 25 | 8am-5pm

The dietary supplement current Good Manufacturing Practices (cGMPs) (21 CFR 111) are performance-based regulations. The rules require persons who manufacture, package, label or hold a dietary supplement to establish and follow cGMPs to ensure the quality of the dietary supplement and to ensure the dietary supplement is packaged and labeled as specified in the master manufacturing record. The cGMPs instruct you on what you have to accomplish; however, there is very little detail in how to go about it. The good news is that you have a great deal of flexibility in how to accomplish the requirements set forth in the cGMPs. The downside is that you have to write SOPs that detail how you will meet those requirements. This course will guide you through constructing an SOP and recordkeeping system. It will walk you through the process of creating SOPs and records. Participants will learn which SOPs are required to have a complete quality system.


Food Safety Modernization Act (FSMA)

Monday, September 25 | 8am-5pm

The recent rule changes associated with the Food Safety Modernization Act (FSMA) will have a dramatic impact on the food safety and regulatory landscape for facilities producing products regulated by the FDA, and compliance deadlines for FSMA are quickly approaching. Although dietary supplements are exempt from the Preventive Controls requirements of 21 CFR 117, the preventive controls are just one part of the seven new rules implemented by FSMA. Dietary supplements are still subject to other parts of 21 CFR 117 and are also required to be compliant with the other applicable rules and regulations established under FSMA.

  • Do you know your HACCP from your HARPC?
  • Do you need to decode which FSMA requirements really apply to you and your company?
  • Do you know what constitutes a preventive control?
  • Do you know what the FDA requires for a Foreign Supplier Verification Program?
  • Are you unsure where to start?

This course will provide an introduction to all seven new rules and regulations established by FSMA and provide insight on which rules impact dietary supplement companies. The course will also provide tools, references and ideas for implementing the changes needed to be compliant with FSMA regulations.

Take this course if you’re directly involved in supply chain, R&D, regulatory, quality or developing food safety plans, or if you have management responsibilities over employees who are.


Vendor Qualification and Auditing

Monday, September 25 | 8am-5pm

This course is designed to give people who want to improve quality in their facility and who already have a basic understanding of the dietary supplement current Good Manufacturing Practices (cGMPs) 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.


Label Claim and Promotion

Tuesday, September 26 | 8am-5pm

The labeling and promotion of your dietary supplement products are the most visible ways that the FDA and the FTC can track your compliance with federal regulations. This course will help you ensure your claims are lawful. It will also enable you to avoid making implied claims that would result in regulatory enforcement. Participants will learn how public knowledge of FTC and FDA enforcement actions affect business performance.


Current State of Non-GMO for Dietary Supplement

Tuesday, September 26 | 8am-Noon

This half-day workshop will teach you how to achieve America's fastest-growing third-party labeling claim: Non-GMO Project Verified. Topics to be covered include current U.S. and international regulations and definitions for GMO/GE labeling, as well as Non-GMO Project standards and requirements to earn the "butterfly" logo. This course will also provide details about NSF's new True North Non-GMO protocol and requirements, including the new dietary supplement specific annex.


Regulatory Requirements for Cosmetics: USA

Tuesday, September 26 | 8am-Noon

This unique, half-day course will provide attendees with the tools necessary to bring their cosmetic products to market, while ensuring compliance with U.S. regulatory requirements. Topics covered will include:

  • How to choose a manufacturer
  • Sufficient raw material information requirements
  • Formulation approvals
  • Testing your product
  • Building a formula dossier
  • Closing data holes before production

Hot topics such as advertising claims, unique laws in the United States, organic/natural standards, labeling requirements (cosmetic and OTC), and FDA registrations will also be covered.


Batch Production Records – “Do’s” and “Don’ts” – 21 CFR 111

Tuesday, September 26 | 1-5pm

Master manufacturing records (MMRs) and batch production records (BPRs) are required under the dietary supplement good manufacturing practices (GMPs). The MMR defines how a product is made; you cannot make a consistent product without a complete MMR. The BPR provides evidence to FDA that the product was made in compliance with the MMR and GMPs. This course will examine common issues and pitfalls with MMRs and BPRS, and provide specific guidance on how to avoid these problems. Best practices will also be highlighted to enable your BPRs not only to withstand audits and inspections, but to streamline and improve internal operations. Participants will learn how to create a streamlined, yet complete, process for developing MMRs.


NDIs and GRAS Notification – A How To

Tuesday, September 26 | 1-5pm

This introductory course will cover how to determine whether you need to submit a New Dietary Ingredient (NDI) Notification and considerations in determining if the use of an ingredient is Generally Recognized as Safe (GRAS). The course is directed toward dietary supplement and food ingredient manufacturers and suppliers that are interested in understanding the basic requirements so they can better communicate with regulators and specialists. Attendees will learn the similarities and differences between GRAS and NDI notifications, and pitfalls to avoid. Topics to be addressed during this three-hour course include:

  • How to describe and characterize your ingredient
  • Documenting history of use
  • How to identify the safety tests required for your ingredient
  • Compiling the necessary documentation
  • Establishing safety under the conditions of intended use
  • When and how to engage experts and the role of the expert panel
  • Future directions and how the food and dietary supplements industries are adapting
  • An overview of the current regulatory landscape