Internal Auditing Training
About This Course
This dietary supplements internal auditing course will help you understand the fundamentals of auditing and how to conduct an internal audit focused on cGMP and other FDA requirements. The training incorporates internal audit best practices, regulatory requirements and information on turning internal audit findings into useful information. Requirements for 21 CFR 111, supplier programs and FSMA are incorporated into the content.
You’ll learn how to prepare, perform, report and close an audit and discuss the importance of using CAPA systems as a follow-up to your internal audit findings.
Key Learning Objectives
At the end of this course, you will know and understand:
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
Who Should Attend?
This course is ideal for new auditors, those preparing to be on an audit team and people who will soon be audited. It is also beneficial for those who are looking to develop or improve their current internal audit programs.
Course 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.
Can’t Attend the Live Course?
Register for the on-demand recordingAdditional 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: January 30 and January 31st, 2025
Time: 1:00 P.M to 5:00 P.M Eastern Time
Cost: $800.00
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.
NSF/ANSI 455-2-2024 Good Manufacturing Practice for Dietary Supplement
The purpose of this training is to understand the requirements for the NSF/ANSI 455-2-2024 Good Manufacturing Practice for Dietary Supplement Standard and how to implement them at your facility. The standard is based on 21 CFR 111 requirements, other regulations (normative references), retailer criteria, and industry best practices. The criteria in this standard were structured to follow a seven (7) systems approach. In this training we will discuss what you will need to prepare in preparation for an audit at your dietary supplement manufacturing facility.
We will not be discussing the need for documented procedures and evidentiary records in depth as this is well documented within the standard as well as the prerequisite Dietary Supplement GMP Training and is always best practice.
The training is divided into two sections:
Section 1
- Context of the organization- this includes requirements for implementing a quality management system (QMS) as well as regulatory requirements.
- Leadership- this includes requirements for management to demonstrate commitment to the QMS, such as assigning roles and responsibilities throughout the organization.
- Planning, which includes requirements for planning for the ongoing function of the QMS.
Section 2
- Support - includes requirements for management of resources for the QMS. This includes buildings and infrastructure, human resources, and control of documents.
- Operation - includes requirements on planning and creating of the product.
- Performance evaluation - includes requirements for monitoring the QMS and evaluation of the product.
- Improvement - includes requirements for taking corrective action for product or process nonconformities, and actions to make the QMS better over time.
Key Learning Objectives
- You will learn the structure of the NSF/ANSI 455-2-2024 Good Manufacturing Practice for Dietary Supplements Standard, with a detailed overview of each section of the standard.
- You will learn the specific requirements of the NSF/ANSI 455-2-2024 Good Manufacturing Practice for Dietary Supplements Standard.
- You will understand the intent of the required programs and elements of the 455-2 standard from the NSF/ANSI 455-2- ARG - Audit Requirements Guidance for Good Manufacturing Practices for Dietary Supplements.
- You will learn best practices on how to implement the required programs and elements of the standard.
- You will learn what documentation is necessary to demonstrate compliance with the standard at your facility.
Who Should Attend?
- Attend this training if you work in:
- Management
- Manufacturing
- Quality control/assurance
- Packaging
- Marketing Laboratory operations
- Auditing
- Suppliers and distributors
- Regulatory affairs
Dates: May 21-23, 2025
Time: 1:00 P.M to 5:00 P.M Eastern Time
Cost: $1000.00
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.
Vendor Qualification and Audit Virtual SupplySide Connect New Jersey Training
Description:
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: March 24, 2025 1:00pm-5:00pm Eastern Time
Day 2: March 25, 2025 1:00pm-5:00pm Eastern Time
Cost: $800.00
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.