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Internal Auditing Training

Dates

Times

2 days

Location

Virtual Learning

Availability

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 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