2019 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)

Tuesday, October 15 - Wednesday, October 16| 8am-5pm

Location:  South Convention Center, Level 3

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.

Pricing:

Early: $1,200

Advance: $1,400

On-Site: $1,800


Food Safety Modernization Act (FSMA)

Tuesday, October 15 | 8am-5pm

Location:  South Convention Center, Level 3

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.

Pricing:

Early: $700

Advance: $900

On-Site: $1,100


Batch Production Records Do's & Don'ts

Tuesday, October 15 | 8am-5pm

Location: South Convention Center, Level 3

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.

Pricing:

Early: $700

Advance: $900

On-Site: $1,100


Dietary Supplement Claim Substantiation

Tuesday, October 15 | 8am-5pm

Location: South Convention Center, Level 3

The labeling and promotion of your dietary supplement products are the most visible ways that the Food & Drug Administration and the Federal Trade Commission can track your compliance with federal regulations. A perfect complement to “Dietary Supplement Labeling Compliance”, this course will go over in detail each type of permitted claim that is available to you and the criteria for making each one. We will cover FDA and FTC standards for substantiation. We will also go over how to build the substantiation for each claim that the FDA and FTC requires you to hold to ensure your claims are accurate and not misleading, and how you can avoid making implied claims which could lead to regulatory enforcement. Participants will learn how public knowledge of FTC and FDA enforcement actions affect business performance, enforcement/litigation trends and other responsibilities of dietary supplement manufacturers such as structure/function claim notification.

Pricing:

Early: $700

Advance: $900

On-Site: $1,100


Botanical Testing

Wednesday, October 16 | 8am-5pm

Location:  South Convention Center, Level 3

This one-day course is designed for any quality assurance
personnel working to meet FDA compliance for Botanical ID. This course is to
analyze botanical unknowns through analytical and molecular methods. This
course may also support in-house testing for botanical ID.

 

QA Testing of Botanicals:

Overview and review of the important aspects of quality assurance in testing and test development of botanical ingredients and its relations to the natural products industry and alternative medicine practices. This lecture will review proposed guidelines for herbal ID testing as it related to Good Manufacturing Practices, cGMP and all issues regarding quality testing.

 

Raw Botanical lecture and labs:

Techniques for identifying botanical species, adulterants and contaminants through analytical and molecular methods will be presented. Participants will be taught through lecture and lab participation how to analytically test and record these subjective systems.

 

Major Course Competencies:

  • Participants will be able to understand the basic concepts and techniques for qualifying and identification of unknown botanicals.
  • Participants will be able to know when to apply each method for the desired results.
  • Participants will become familiar with at least a doezen herbals during this class.
  • Participants will become acquainted with reference materials used within this field of study.
  • Participants will know how to document and report their findings

 Sensory Evaluation:

  • Overview of class
  • Discussion of the current status of the matrix of the natural products industry
  • Methods of identification
  • Labs on contaminants and adulterants, depending on available samples
  • Discussion on reference materials

 

Pricing:

Early: $700

Advance: $900

On-Site: $1,100


Vendor Qualification and Audit Training

Wednesday, October 16 | 8am-5pm

Location: South Convention Center, Level 3

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 GMPs, 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.

Pricing:

Early: $700

Advance: $900

On-Site: $1,100


Dietary Supplement Label Claim Compliance

Wednesday, October 16 | 8am-5pm

Location: South Convention Center, Level 3

It is up to dietary supplement manufacturers to ensure their supplement labels are compliant before they go to market, however the regulations can be confusing and difficult to interpret. Label noncompliance can cause your product to be considered misbranded and subject to Food & Drug Administration regulatory action. Learn about the regulations that govern dietary supplement labeling including what can be considered a dietary supplement, mandatory aspects on the principal display panel, Supplement Facts formatting, ingredient lists, and type of permitted claims, enforcement/litigation trends, and other responsibilities of dietary supplement manufacturers such as Adverse Event Reporting. The course is interactive, with hands-on exercises. Bring your questions and prepare to interact with the instructor and your peers in the industry.

This course is geared to those individuals involved in  the dietary supplement industry including:

• Management                                           • Marketing

• Quality Control/Assurance                    • Packaging

• Sales                                                          • Laboratory Operations

• Product Development                            • Suppliers and Distributors

• Regulatory Affairs                                   • Legal

 

Pricing:

Early: $700

Advance: $900

On-Site: $1,100