NSF Training Courses

Virtual Training April 18 - April 28, 2022

SupplySide East has again partnered with NSF Health Sciences to offer you education courses to expand your industry knowledge on regulatory requirements and risk mitigation.

Courses and payment take place within the NSF Health Sciences platform. 

 


21 CFR 111 Dietary Supplement GMP Overview

Attend an extensive 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. 

Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.

Duration of Class:

16 Hours

Date(s) of Class:

  • Monday, April 18 | 11am-4pm ET
  • Tuesday, April 19 | 11am-4pm ET
  • Wednesday, April 20 | 11am-5pm ET

Cost of Class:
$1,400.00

 

Trainer: 

Norm Howe  


Dietary Supplement Label Compliance

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.

  • Label compliance/noncompliance
  • Regulations that govern dietary supplement
  • Supplement Facts formatting
  • Ingredient lists
  • Permitted claims, enforcement/litigation trends
  • Adverse Event Reporting. The course is interactive
  • The Regulatory Background and Enforcement · Mandatory Label Elements
  • Voluntary Label Elements
  • How to apply the FTC and FDA regulations

 

Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.

Duration of Class:

6 Hours

Date of Class:

Thursday, April 21 | 11am-5pm ET

Cost of Class:
$600.00

 

Trainer: 

Erin Taraborrelli 


QMS Technical Writing & Audit Observation Report Writing

This training covers the documentation needed for a robust Quality Management System (QMS) when manufacturing dietary supplements, as well as the best practices to follow when conducting internal audits. The first section of the course covers types of documentation and associated best practices. Emphasis will be placed on the procedures and documentation required for when deviations or unexpected occurrences are encountered and the associated material reviews and CAPA process needed. In the second section of the course, we will take a deeper dive into internal auditing and the audit documentation.

 

PART I – QMS Documentation

  • Documentation Requirements and Best Writing Practices
  • Programs and Policies, Standard Operating Procedures (SOP), MMRs & BPRs, Specification Sheets, Forms and
    Logs
  • Investigative and Corrective Documentation
  • Deviation /Non-Conformance Reports, Material Review, Corrective and Preventative Action (CAPA) reports 
  • Documentation Protocols
  • Good Documentation Practices, Change Control Document and Revision Control, Record Retention, Requirements for Electronic Records, Training

 

PART II – Audit Observation Reporting

  • Internal Audit Basics and Best Practices
  • Introduction to Internal Auditing
  • Using Checklists
  • Conducting the Audit
  • Incorporating Regulatory and cGMP Requirements in Internal Auditing
  • 21 CFR 111 and 21 CFR 117 for Warehousing and Distribution
  • Supplier Program Requirements
  • Records and Procedures
  • Turning Audit Findings into Useful Information and Continuous Improvement
  • Communicating Audit Reports
  • Importance of a Good CAPA system

 

Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.

Duration of Class:

8 Hours

Date of Class:

  • Thursday, April 21 | 11am-3pm ET
  • Friday, April 22 | 11am-3pm
Cost of Class: 
$800.00
 

Trainer: 

Vijay Bachus 


Dietary Supplement Claims Substantiation

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 “Introduction to Product Labeling for Dietary Supplement”, 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, 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.


Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.

Duration of Class:

6 Hours

Date of Class:

Tuesday, April 26 | 11am-5pm ET

Cost of Class: 
$600.00
 

Trainer: 

Nicole Leitz


Vendor Qualification and Audit Training

Unless you intend to test every shipment of every component for every specification, you must qualify your vendors. But FDA does not provide much guidance on how to qualify vendors. This class is designed for 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.

At the end of this course attendees will have an understanding of:

  • The regulations that apply to Vendor Qualification 21 CFR 111  
  • The impact of FSMA on Supplier Qualification
  • Risk assessment and risk management
  • Supplier monitoring activities
  • Onsite Audit Strategies & Requirements
  • Managing the audit process effectively-before, during after
  • The consequences of noncompliance

 

Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.

Duration of Class:

8 Hours

Date(s) of Class:

  • Wednesday, April 27 | 11am-3pm ET
  • Thursday, April 28 | 11am-3pm ET
Cost of Class:
$800.00

 

Trainer: 

Shawn Ludlow