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Non GMO Project Verification for Dietary Supplements 
- April 30, 2020 @ 1 PM ET

Build consumer and retailer trust in verified labels claims by earning the sought-after "butterfly" logo for your product or ingredient. 

• Learn how to help products stand out in the category with this collaborative 2-hour workshop for Non-GMO Project Verification, focusing on: 
  • Defining risk levels
  • Classifying ingredients
  • Identifying specific requirements for common dietary supplement ingredients
  • Facility level compliance requirements 
• Work through common sourcing and ingredient challenges with hands on exercises and case studies
• Make sense of complex regulations so they can be applied to your organization's formulations and ingredients
• Become an in-house expert at Non-GMO Project definitions, standards and requirements

Upcoming Online Training Courses
 

 Batch Production Records - September 18th 1PM

• Take part in a collaborative online training developed to streamline the MMR development processes, focusing on:
  • The difference between an MMR and a BPR
  • The regulatory requirements for MMRs for dietary supplements
  • FDA requirements for BPRs
• Gain specific guidance to help manage and avoid common issues and pitfalls with MMRs and BPRs
• Learn best practices to simplify and improve your internal operations - enabling your batch records to withstand audits and inspections.

Upcoming Online Training Courses
 

Two Tracks of Courses: QMS/GMP & Product Compliance

Starting August 3rd, NSF and Informa are offering an array of courses that cover both aspects of both quality and product compliance. The QMS/GMP track will provide an overview of the 21 CFR 111 GMPs for dietary supplement manufacturers as well as various focus areas to consider that may pose areas of risk, while the product compliance track covers specific considerations as it pertains to product safety and quality.


Quality Systems & GMP Track:

• 21 CFR 111 Dietary Supplement GMP Training
• Introduction to Vendor Qualification
• Top 10 Audit Findings & Ways to Get a Warning Letter
• Cleaning and Sanitizing for Dietary Supplement Manufacturers
• Foreign Supplier Verification for Dietary Supplement Companies
• 21 CFR 121 Food Defense Plans for Dietary Supplement Companies
• 21 CFR 117 for Dietary Supplement Companies

• NDI and GRAS Notification - A How To
• Non-GMO Project Verification for Dietary Supplements
• Introduction to Product Labeling
• Dietary Supplement Claims Substantiation 
• Introduction to Positive ComplianceT
• Botanical Identification and Testing 
• Designing Quality into New Products to Win in the Marketplace

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Batch Production  Records - Online Instructor Led Training
 

This April 20th course is part of maintaining required compliance to 21 CFR 111 and provides opportunities for ongoing GMP training. Participants will:

• Take part in a collaborative online training developed to streamline the MMR development processes, focusing on:
  • The difference between MMR and BPR
  • The regulatory reuirements for  MMRs for dietary supplement
  • FDA requirements for BPR
• Gain specific guidance to help manage and avoid common issues and pitfalls with MMRs and BPRs 
• Learn best practices to simplify and improve your internal operations - enabling your batch records to withstand audits and inspections 

Upcoming Online Training Courses
 

 Food Safety Plans & Hazard Analysis for Dietary Supplement Industry
  -  August 28, 2020 @ 1 PM

Dietary supplement manufacturers and raw material suppliers are not exempt from all the requirements of 21 CFR 117 and may be required to have a written food safety plan. In this one-hour webinar we will highlight the key obligations under 21 CFR 117 subpart C that are required for all raw material suppliers and any manufacturer that makes a product with a Nutrition Facts label. 

By combining extensive industry experience and concrete understanding of regulations with flexible and convenient training, participants in this course will: 

• Understand the components of a Food Safety Plan and what raw material suppliers need to do to be compliant 
• Identify where to find the new regulations under 21 CFR
• Learn the additional GMP requirements for dietary supplements found in 21 CFR 117 subpart B

Upcoming Online Training Courses
 

NSF's SupplySide Training Sessions: Dec. 1-11

• 21 CFR 111 Dietary Supplement GMP Overview
• Dietary Supplement Claims Substantiation 
• Introduction to Vendor Qualification
• Foreign Supplier Verification for Dietary Supplement Companies

 Foreign Supplier Verification Program
June 4, 2020 @ 1 PM

New regulations for the Foreign Supplier Verification Program (FSVP) have modified requirements for dietary Supplement companies and raw material suppliers to be complaint under 21 CFR 1 Subpart L. This one-hour training highlights the key requirements of the FSVP for raw material suppliers and dietary supplement companies and these requirements are an extension of 21 CFR 111.

By combining extensive industry experience and concrete understanding of regulations with flexible and convenient training, participants in this course will:

• Learn the definition of who is an importer under FSVP regulation
• Understand how the requirements are modified for dietary supplements and their components.
• Review the documentation required for compliance
• Identify where the regulations are found under 21 CFR regulation
• Know when an onsite audit may be required and what are your options are for compliance

Upcoming Online Training Courses
 

 Onsite or Virtual Vendor Verification Audits & Follow-Up Consulting

Protect your brand and reduce the risk of FDA violation with services that cater to your specific goals and timing needs. From a one-time initial supplier verification to routine and ongoing process improvement services, with services from NSF clients can:

• Alleviate stress and help verify GMP, ingredient, finished product, or warehouse and distribution practices and procedures are aligned with GMP regulatory requirements and best practices.
• Protect the health and safety of customers by helping to ensure products are manufactured safely with known regulatory audit frameworks or organizational requirements based on your companies' priorities.
• Help ensure continued partnerships by improving supplier practices and procedures with tailored consulting services following an audit such as: standard operating procedures writing and quality program development training.

Upcoming Online Training Courses
 

Non GMO Project Verification for Dietary Supplements 
- May 28, 2020 @ 1 PM ET

Build consumer and retailer trust in verified labels claims by earning the sought-after "butterfly" logo for your product or ingredient. 

• Learn how to help products stand out in the category with this collaborative 2-hour workshop for Non-GMO Project Verification, focusing on: 
  • Defining risk levels
  • Classifying ingredients
  • Identifying specific requirements for common dietary supplement ingredients
  • Facility level compliance requirements 
• Work through common sourcing and ingredient challenges with hands on exercises and case studies
• Make sense of complex regulations so they can be applied to your organization's formulations and ingredients
• Become an in-house expert at Non-GMO Project definitions, standards and requirements

Upcoming Online Training Courses
 

2 Part Label Claim Promotion: April 16 @ 1pm ET

Help establish in-house subject matter expertise on your Dietary Supplement label claims and promotions. Online training includes:

• Stay up to date and navigate the maze of FDA and FTA regulations and enforcement 
• Ensure your advertising and branding complies with FTC regulations 
• Learn how to differentiate between health, qualified, implied and expressed claims
• Understand how to develop compliant structure function claims including disclaimers and substantiation 

Custom Virtual Consulting Options

We know continuous improvement and compliance remains a top priority for businesses big and small.  A skilled NSF consultant can provide you with a gap assessment against GMP requirements and best practices in the dietary supplements and cosmetics industries.  We offer a "touch free" audit, consulting, and training services. 

Upcoming Online Training Courses

Onsite or Virtual GMP Policy and Procedure Training & Implementation 

Protect your brand and reduce the risk for FDA violations with training that caters to your specific policy and procedure compliance needs.

• Save money by reducing inefficient policy and procedures and repetitive errors. 
• Alleviate stress and wasted time by ensuring employees are completing procedures correctly the first time. 
• Improve employee satisfaction by reducing inefficiency and errors in policies and procedures
• Transition management from supervisors to leaders by enabling understanding of how to delegate. 

 Dietary Supplements Claims Substantiation
June 9, 2020 @ 1 PM

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.

Learning objectives:

• FDA and FTC standards for substantiation
• Responsibilities of dietary supplement manufacturers such as structure/function claim notification process
• Enforcement and litigation trends

 21 CFR 117 for the Dietary Supplement Industry
June 11, 2020 @ 1 PM

Dietary supplement manufacturers may be exempt for the preventative controls requirements of 21 CFR 117, but they are not completely exempt from all aspects of this new regulation. In this one hour training, we will highlight the aspects of 21 CFR 117 that apply to dietary supplement manufacturers and raw material suppliers.

You will learn what new cGMP requirements found in subpart B of 21 CFR 117 are required for dietary supplement manufacturers and are now an extension of the cGMP requirements in 21 CFR 111. This course will help you learn how to determine which parts of 21 CFR 117 apply to dietary supplement manufacturers and raw material suppliers.

Learning objectives:

• Understanding of FSMA regulations
• Focus on 21 CFR 117 impact on dietary supplement manufacturers and raw material suppliers
• Learn additional GMP requirements for dietary supplements found in 21 CFR 117 subpart B

Upcoming Online Training Courses
 

Botanicals Identification & Testing Course Part 1 & Part 2 

This 2-part series is an overview of the guidance on testing methodology, specifications, and ingredient identification for botanicals. Participants will:

• Identify botanical unknowns
• Investigate the characterization of botanicals
• Differentiate between natural and adulterated botanicals
• Review organoleptic characterization.
• Learn hot High Performance Liquid Chromatography (HPLC) can be used for testing

 21 CFR 121 Food Defense Plans for the Dietary Supplement Industry  -  August 27, 2020 @ 1 PM

This 1.5 hour training is an introduction to the 21 CFR 121 regulation focusing on how to create a compliant food defense plan for the dietary supplement industry as required by the FDA. This convenient online training delivers extensive industry experience, real-world case studies, and sample worksheets for immediate use with your business. 

Participants will: 

• Understand a Food Defense Plan and recognize the required components
• Make sense of FDA interpretations of intentional adulteration in the dietary supplement industry under FSMA
• Evaluate how the 21 CFR 121 regulation applies to dietary supplement manufacturers and raw material suppliers
• Work through how to perform a vulnerability assessment with real-world examples
• Receive mitigation strategy examples and vulnerability assessments along with FDA references and guidance documents.

Upcoming Online Training Courses
 

2 Part Label Claim Promotion: July 9 @ 1pm ET

Help establish in-house subject matter expertise on your Dietary Supplement label claims and promotions. Online training includes:

• Stay up to date and navigate the maze of FDA and FTA regulations and enforcement 
• Ensure your advertising and branding complies with FTC regulations 
• Learn how to differentiate between health, qualified, implied and expressed claims
• Understand how to develop compliant structure function claims including disclaimers and substantiation 

Custom Virtual Consulting Options

We know continuous improvement and compliance remains a top priority for businesses big and small.  A skilled NSF consultant can provide you with a gap assessment against GMP requirements and best practices in the dietary supplements and cosmetics industries.  We offer a "touch free" audit, consulting, and training services. 

Upcoming Online Training Courses

Botanicals Identification & Testing Course Part 1 & Part 2 

This 2-part series is an overview of the guidance on testing methodology, specifications, and ingredient identification for botanicals. Participants will:

• Identify botanical unknowns
• Investigate the characterization of botanicals
• Differentiate between natural and adulterated botanicals
• Review organoleptic characterization.
• Learn hot High Performance Liquid Chromatography (HPLC) can be used for testing

Two Tracks of Courses: QMS/GMP & Product Compliance

Starting August 3rd, NSF and Informa are offering an array of courses that cover both aspects of both quality and product compliance. The QMS/GMP track will provide an overview of the 21 CFR 111 GMPs for dietary supplement manufacturers as well as various focus areas to consider that may pose areas of risk, while the product compliance track covers specific considerations as it pertains to product safety and quality.


Quality Systems & GMP Track:

• 21 CFR 111 Dietary Supplement GMP Training
• Introduction to Vendor Qualification
• Top 10 Audit Findings & Ways to Get a Warning Letter
• Cleaning and Sanitizing for Dietary Supplement Manufacturers
• Foreign Supplier Verification for Dietary Supplement Companies
• 21 CFR 121 Food Defense Plans for Dietary Supplement Companies
• 21 CFR 117 for Dietary Supplement Companies

• NDI and GRAS Notification - A How To
• Non-GMO Project Verification for Dietary Supplements
• Introduction to Product Labeling
• Dietary Supplement Claims Substantiation 
• Introduction to Positive ComplianceT
• Botanical Identification and Testing 
• Designing Quality into New Products to Win in the Marketplace

Batch Production  Records - Online Instructor Led Training
 

This April 20th course is part of maintaining required compliance to 21 CFR 111 and provides opportunities for ongoing GMP training. Participants will:

• Take part in a collaborative online training developed to streamline the MMR development processes, focusing on:
  • The difference between MMR and BPR
  • The regulatory reuirements for  MMRs for dietary supplement
  • FDA requirements for BPR
• Gain specific guidance to help manage and avoid common issues and pitfalls with MMRs and BPRs 
• Learn best practices to simplify and improve your internal operations - enabling your batch records to withstand audits and inspections 

Upcoming Online Training Courses
 

Participants will learn:

• Importance of sanitary facility design
• How your team can build contamination prevention mitigation into the construction of the facility
• How to write a compliant environmental monitoring plan
• What specific SOPs are required for general facility cleaning and sanitation

Upcoming Online Training Courses
 

NDI's and GRAS Notification - A How to Online Training - May 5, 2020 @ 1 PM ET

This course is part of understanding required DSHEA regulation for manufacturing dietary supplements with new ingredients and submitting a New Dietary  Ingredient Notification (NDIN) to the FDA. A simplified online technical training helps attendees break down and understand complex testing results and quantitative data.  

Participants will: 

• Assess the need to submit an NDIN and determine if another regulatory pathway is more appropriate
• Understand the similarities and differences in the requirements for an NDIN submission and a GRAS notification to the FDA
• Identify what kind of information and testing to include for a successful FDA review
• Establish safety under the intended use conditions
• Analyze and document information to demonstrate that the intended use will not result in any adverse health effects
• Identify and avoid common issues associated with NDIN submissions through real-world examples 

Upcoming Online Training Courses
 

21 CFR 121 Food Defense Plans for Dietary Supplement - April 27, 2020 @ 1 PM ET

This 1.5 hour training is an introduction to the 21 CFR 121 regulation focusing on how to create a compliant food defense plan for the dietary supplement industry as required by the FDA. This convenient online training delivers extensive industry experience, real-world case studies, and sample worksheets for immediate use with your business. 

Participants will: 

• Understand a Food Defense Plan and recognize the required components
• Make sense of FDA interpretations of intentional adulteration in the dietary supplement industry under FSMA
• Evaluate how the 21 CFR 121 regulation applies to dietary supplement manufacturers and raw material suppliers
• Work through how to perform a vulnerability assessment with real-world examples
• Receive mitigation strategy examples and vulnerability assessments along with FDA references and guidance documents.

Non GMO Project Verification for Dietary Supplements 
- April 30, 2020 @ 1 PM ET

Build consumer and retailer trust in verified labels claims by earning the sought-after "butterfly" logo for your product or ingredient. 

• Learn how to help products stand out in the category with this collaborative 2-hour workshop for Non-GMO Project Verification, focusing on: 
  • Defining risk levels
  • Classifying ingredients
  • Identifying specific requirements for common dietary supplement ingredients
  • Facility level compliance requirements 
• Work through common sourcing and ingredient challenges with hands on exercises and case studies
• Make sense of complex regulations so they can be applied to your organization's formulations and ingredients
• Become an in-house expert at Non-GMO Project definitions, standards and requirements

Upcoming Online Training Courses
 

 21 CFR 111  for the Dietary Supplement Industry  June 23-25, 2020 @ 1 PM

This course is part of maintaining required compliance to 21 CFR 111 and provides opportunities for ongoing GMP training. Participants will:

• Take part in 3 manageable one day sessions providing an overview of subparts A-P of the 21 CFR 111 regulation including:
  • Specifications
  • Master Manufacturing Records / Batch Records
  • Quality and FDA authority
  • Warning Letters
• Make sense of complex regulations in an understandable and comprehensive manner 
• Effectively convert regulations into real world examples and scenarios, offering clarity and operational success
• Identify how the regulations can be applied to your organization in a cost effect manner

Upcoming Online Training Courses
 

Two Tracks of Courses: QMS/GMP & Product Compliance

Starting August 3rd, NSF and Informa are offering an array of courses that cover both aspects of both quality and product compliance. The QMS/GMP track will provide an overview of the 21 CFR 111 GMPs for dietary supplement manufacturers as well as various focus areas to consider that may pose areas of risk, while the product compliance track covers specific considerations as it pertains to product safety and quality.


Quality Systems & GMP Track:

• 21 CFR 111 Dietary Supplement GMP Training
• Introduction to Vendor Qualification
• Top 10 Audit Findings & Ways to Get a Warning Letter
• Cleaning and Sanitizing for Dietary Supplement Manufacturers
• Foreign Supplier Verification for Dietary Supplement Companies
• 21 CFR 121 Food Defense Plans for Dietary Supplement Companies
• 21 CFR 117 for Dietary Supplement Companies

• NDI and GRAS Notification - A How To
• Non-GMO Project Verification for Dietary Supplements
• Introduction to Product Labeling
• Dietary Supplement Claims Substantiation 
• Introduction to Positive ComplianceT
• Botanical Identification and Testing 
• Designing Quality into New Products to Win in the Marketplace

August Sessions

August 13th - 1:30pm-3:30pm EST Plenary Session Panel 

Hear from industry leaders like Katie Fillinger of NSF, Randy Fields of Repositrak Ella Riggs of Whole Foods & GRMA Governance Board, and more.

Topics to be discussed:

• Both the advantages & challenges associated with Virtual/Remote Audits
• GRMA Virtual/Remote Guidance Document
• Certification Bodies Capabilities.

August 20th - 1:00pm - 2:00pm EST Learning Session 
Employee Protection/Masks, Kim Trautman, Executive Vice President of Medical Device Services, NSF International,

Know Your Masks - We've all heard of the benefits, but come find out what mask is right for you and your business environment.

Review of mask types:  

• N95 
• K95 
• Medical and surgical 
• DIY cloth coverings