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:
Norman Howe - Norman Howe is an experienced quality consultant. Norman has taught a course in quality systems as adjunct faculty at the University of Michigan, Ann Arbor. He serves as an expert witness in FDA-regulated product quality cases.
Previously, Norman was the plant manager of a pharmaceutical plant with BASF and was responsible for manufacturing, quality assurance, engineering, maintenance, contract manufacturing and a small product development group.
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: 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.
21 CFR 111 Dietary Supplement GMP Overview
This training course is 16-Hours split over 3-days. FDA expects all companies that manufacture, package, or hold dietary supplement products to follow 21 CFR 111, the Dietary Supplement CGMPs. This course provides a basic understanding of CGMPs and the responsibilities expected for various individuals and groups within the company. Participants will learn how to apply CGMP principles to specific situations. The course is interactive, with hands-on exercises including case-studies from recent Warning Letters.
As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training on a regular basis.
Course Prerequisites: None
Date: November 13, 2024
Time: 12:00 pm to 5:00 pm Eastern Time
Date: November 14, 2024
Time: 12:00 pm to 5:00 pm Eastern Time
Date: November 15, 2024
Time: 12:00 pm to 6:00 pm Eastern Time
Cost: General Registration $1200.00
*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.
Batch Production Record (BPR) and Master Manufacturing (MMR)
This course is 2.5-Hours. Join us for an interactive hands-on virtual training, designed to provide participants with practical tips to help improve efficiency in their MMR and BPR processes. This course is part of maintaining required compliance to 21 CFR 111 and provides opportunities for ongoing GMP training. Combining extensive industry experience and concrete understanding of regulations with flexible and convenient training, participants in this course will:
Take part in a collaborative online training developed to streamline the MMR development processes, focusing on:
Date: November 6, 2024 1:00 P.M to 3:30 P.M Eastern Time
Cost: $450.00
*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.