Introduction to Vendor Qualification

Dates

Times

1 day

Location

Virtual Learning

Availability

About This Course

Supplier or vendor qualification is a crucial component in compliance to 21 CFR 111. The FDA requires that manufacturers of dietary supplements must “qualify” each of their vendors but do not provide guidance on how a company is to perform this qualification. Supplier qualification principles also apply to subcontracted services affecting cGMP (manufacturing steps, packaging and labeling, testing and/or calibration services, storage and distribution, etc.) Any supplier qualification program must include two critical components:

  1. Clearly defined specifications/requirements for all of these goods or services being purchased, and;
  2. Objective evidence to show that your requirements are being consistently fulfilled.

This four-hour training will provide you with the tools, guidelines and information on best industry practices as well as offer guidance on how to achieve both of the above critical requirements in ways that will enable compliance with cGMP and make the most efficient use of your resources.

Key Learning Objectives

At the end of this training, you will know and understand:

  • What is required by the FDA under 21 CFR 111 and FSMA
  • How to apply vendor qualification activities and requirements
  • Supplier monitoring
  • Supplier approval
  • Tools and reference materials

Who Should Attend

This course is valuable for QA/QC, regulatory and compliance, laboratory, and other key personnel who are in charge of or a part of implementing a new or modifying an existing vendor qualification program into their dietary supplement companies’ operations. The course would also be useful for purchasing and production managers, who may be involved in the vendor determination process and could benefit from understanding some of the elements in qualifying a supplier.

Instructors

Course instructors will be selected from the following:

Jennifer Alfrey - Jennifer has a master’s degree in nutrition and over 25 years of experience in the dietary supplement and cosmetic industries. Her experience ranges from product innovation to global regulatory compliance with experience in formulating, developing, and registering nutrition and cosmetic products in over 150 different countries.

Jennifer has also successfully built cGMP compliant quality management systems from the ground up for dietary supplement manufacturing operations. She has launched quality systems that include compliant documentation of procedures, MMRs, specifications, complaints, laboratory testing, test method development and manufacturing processes.

Nicole Leitz - Nicole Leitz has more than 20 years of experience in the 21 CFR regulated industries. She has written and presented numerous training sessions on quality system elements and best cGMP practices to corporate clients and at national conventions. Nicole is also an experienced remediation consultant. She has advised, and written documentation such as SOPs and WIs and has completed root cause investigations, CAPAs and complaints for corporate clients.

Nicole has a Master of Science degree in organic chemistry from Bucknell University and a Bachelor of Science in ACS chemistry from Hope College.

Shawn Ludlow - Shawn Ludlow is a well-established NSF GMP instructor. He has created several third-party certified quality programs compliant with 21 CFR 111, ISO 9001:2000 and FAMI–QS.

With an undergraduate degree in chemistry, master’s degree in public health and experience working as an analytical chemist for several years, Shawn found his education and work experience combination to be a natural fit for dietary supplement manufacturers looking to improve their quality programs.

Can’t Attend the Live Course?

Register for the on-demand recording

Additional Recommended Courses

21 CFR 111 Dietary Supplement GMP Overview Intro

This course provides an overview of 21 cCFR 111, the Dietary Supplement CGMPs. This abridged course includes an introduction to current good manufacturing practices (cGMPs), required product quality elements, documentation, investigations and a brief overview of the relevant subparts. We will also review the proper way to execute GMP records, detail the personal hygiene requirements, examine the meaning of master and batch records for control of production, labeling and packaging, clarify the requirements of quality and describe the purpose of GMP rules, regulations and FDA enforcement.
o Personnel
o Buildings and Facilities
o Equipment
o Facility Records
o Production and Process Control
o Holding and Distribution
o Batch Records
o Packaging and Labeling
o Quality Control and Quality Assurance
o Laboratory Operations
o Product Complaints
· The role of the FDA and their authority
· The roles and responsibilities of the Quality Unit
As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training on a regular basis.
Dates: December 5, 2024 & December 6, 2024
Time: 1:00 P.M to 5:00 P.M Eastern Time

Cost: $900.00
Course Prerequisites: None

*Register 3 or more attendees from the same company and receive a 10% discount off each registration*

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

Course log in details will be sent in a separate email. Certificate of attendance will be issued upon completion of the course. Completion of the course means being in attendance 95% of the log in time.

Virtual Classroom Training
ISO 22716: Good Manufacturing Practices for Cosmetic and Personal Care Professionals

This course is 8-hours. The ISO 22716 GMP cosmetics training will show you how to identify regulatory non-compliances before they become an issue, minimizing risk while adding measurable value to the manufacturing process. This course has been updated with information from the U.S. FDA's draft guidance for cosmetics manufacturing, U.S. FDA's GMP Inspection Checklist for Cosmetics, and general requirements from the Modernization of Cosmetic Regulations Act (MoCRA) enacted in December 2022.

Learners will understand globally recognized ISO 22716 standards and the U.S. FDA’s draft guidance for cosmetics manufacturing.

This course is geared to those individuals involved in the cosmetics Industry including:

· Marketing

· Quality Control/Assurance

· Packaging

· Manufacturing

· Laboratory Operations

· Suppliers and Distributors

· Auditing

· Regulatory Affairs

· Sales

· Retailers

· Product Development

· Brand Holders


Day 1: June 13, 2024

Day 2: June 14, 2024

Time: 9:00 A.M. to 1:00 P.M. Eastern Time (Both Days)


Cost: $1100.00


Register 3 or more attendees from the same company and receive a 10% discount off each registration

Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification. Course log in details will be sent in a separate email. Certificate of attendance will be issued upon completion of the course. Completion of the course means being in attendance 95% of the log in time.

Virtual Classroom Training
Vendor Qualification and Audit Training for Dietary Supplements

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. These skills and techniques will be useful when conducting internal audits as well as performing audits of suppliers

Day 1: June 20, 2024 1:00pm.-5:00pm Eastern Time
Day 2: June 21, 2024 1:00pm-5:00pm Eastern Time

Cost: $900.00

Completion of the course means being in attendance 95% of the log in time. Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification. Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.

Virtual Classroom Training