GMP Training

Register Today to Increase Market Credibility

The surest way to increase your market credibility is with GMP registration. To help you achieve this, SupplySide West offers seven training courses from the best in the business – NSF International. GMP registration also underscores your commitment to public safety and assures your products have the strength, composition, quality and purity specified on your labels.

The recent increase in FDA inspections and enforcement emphasize the importance of knowing GMPs inside and out. Now's your chance to get registered, and reap the benefits.

GMP Training Presented by
NSF Informa

Join us at the industry's gathering point where science & strategy intersect

Act now, early bird pricing ends August 7
SupplySide West is all about the exploration, discovery, innovation and marketing strategy around the development of finished consumer goods that drive the global business economy

21 CFR 111 Dietary Supplement GMP Overview

Monday, October 5 & Tuesday, October 6

This extensive two-day training course covers 21 CFR 111, the current good manufacturing practices (cGMPs) in manufacturing, packaging, labeling or holding operations for dietary supplements. This course is geared to individuals involved in the dietary supplement industry including those from the following areas: manufacturing, management quality control/assurance, laboratory operations, labeling, auditing, suppliers and distributors, and regulatory affairs. These guidelines are intended to apply to dietary supplements as defined and covered by the U.S. Food and Drug Administration’s Code of Federal Regulations Title 21, Part 111 (Current Good Manufacturing Practices in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements) also known as 21 CFR Part 111.

Two Day Course:
Monday, October 5 – 8am-5pm
AND
Tuesday, October 6 – 8am-5pm

Cost:
Early Bird Price Now-August 7 $1,200
Pre-Registration Price August 8-October 2 $1,300
Onsite Price October 3-Onsite $1,400
The Top 10 Ways to Get a Warning Letter – for Dietary Supplement Manufacturers

Tuesday, October 6

NSF has gathered data from recent FDA inspections, from ex-FDA inspectors and from its own auditors to bring you the latest trends in dietary supplement inspections. As in previous years, dietary ingredient identification is hot again! But you’ll be amazed at which issues have dropped off the list and which ones have clawed their way to the top.

One Day Course:
Tuesday, October 6 – 8am-5pm

Cost:
Early Bird Price Now-August 7 $800
Pre-Registration Price August 8-October 2 $900
Onsite Price October 3-Onsite $1,000
SOPs and Record Keeping for Compliance to 21 CFR 111

Monday, October 5

According to the FDA, if it wasn’t written down, it didn’t happen. Record keeping and documentation are a key component for compliance to 21 CFR 111. Through the cGMP regulations that were enacted in June of 2007, the FDA has established industry-wide standards to ensure identity, purity, strength and composition of manufactured dietary supplements. The regulations are specific with respect to the procedures that must be in place, and the records that must be maintained in support of those procedures; however, they are somewhat vague and don’t offer clear guidelines for achieving compliance. In addition, companies are left to determine the level of compliance they need to put in place, and the frequencies for tasks that must be performed in order to continue to comply with the regulations. This course walks through the regulation, providing guidance on the necessary documentation and tools for compliance.

One Day Course:
Monday, October 5 – 8am-5pm

Cost:
Early Bird Price Now-August 7 $800
Pre-Registration Price August 8-October 2 $900
Onsite Price October 3-Onsite $1,000
Bring Your Product to Market-Regulatory Requirements to Launch

Monday, October 5

This unique, one-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 good 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 U.S., organic/natural standards, labeling requirements (cosmetic and OTC), and FDA registrations will also be covered. Attendees will be afforded the opportunity to discuss and practice in round table exercises with industry experts.

One Day Course:
Monday, October 5 - 8:30am-5pm

Cost:
Early Bird Price Now-August 7 $795
Pre-Registration Price August 8-October 2 $895
Onsite Price October 3-Onsite $995
FDA Inspection Readiness Training

Monday, October 5 or Tuesday, October 6

This course provides attendees the tools necessary to successfully manage an inspection by the FDA. The implementation deadlines for 21 CFR 111 have passed, and the FDA is actively auditing all sizes of companies involved in the manufacturing, packaging, labeling, holding and distributing of dietary supplements. Establishing a good reputation with the FDA takes a long time, and only one negative inspection can seriously damage that reputation. Ensuring the most positive outcome for your cGMP inspection requires careful planning and preparation well before it occurs, successful management of many issues during the inspection itself, and thorough follow-up after the inspection. This course provides real-world examples and utilizes classroom exercises that will take each participant through the different phases of an FDA audit, demonstrating tools and techniques for successfully managing an inspection.

One Day Course:
Monday, October 5 - 8am-5pm
OR
Tuesday, October 6 - 8am-5pm

Cost:
Early Bird Price Now-August 7 $800
Pre-Registration Price August 8-October 3 $900
Onsite Price October 4-Onsite $1,000
Botanical Testing – Hands-On and Analytical Test Methods

Monday, October 5 or Tuesday, October 6

This course is designed for any quality assurance personnel working to meet FDA compliance for botanical identification (ID), and will analyze botanical unknowns through classical botany and sensory testing systems for botanical ID. This course may also support in-house testing for botanical ID by reviewing the important aspects of quality assurance in testing and test development of botanical ingredients and its relation to the natural products industry and alternative medicine practices. Proposed guidelines for herbal ID testing will be reviewed as it relates to GMPs, cGMP, and all issues regarding quality testing. Participants will be taught through lecture and lab participation how to analytically test and record these subjective systems.

One Day Course:
Monday, October 5 - 8am-5pm
OR
Tuesday, October 6 - 8am-5pm

Cost:
Early Bird Price Now-August 7 $800
Pre-Registration Price August 8-October 2 $900
Onsite Price October 3-Onsite $1,000
Batch Production Records – Do's and Don'ts

Tuesday, October 6

Formal Master Manufacturing Records (MMRs) and Batch Production Records (BPRs) have long been required in the pharmaceutical world, but the new Good Manufacturing Practices for dietary supplements (21 CFR 111) bring these requirements to this industry as well. Deficiencies in MMRs and BPRs are among the most frequently cited during audits or inspections, including those from FDA. 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 batch records not only withstand audits and inspections, but also streamline and improve your internal operations.

Half Day Course:
Tuesday, October 6 – 8am-Noon

Cost:
Early Bird Price Now-August 7 $500
Pre-Registration Price August 8-October 2 $600
Onsite Price October 3-Onsite $700
NDIs and GRAS Notification – A How To

Monday, October 5

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 who 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 contract good laboratory practice (GLP) toxicology studies
  • 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

Half Day Course:
Monday, October 5 – 8am – Noon

Cost:
Early Bird Price Now-August 7 $400
Pre-Registration Price August 8-October 2 $500
Onsite Price October 3-Onsite $600