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 will be selected from the following:
Norman Howe - Norman Howe is Senior Partner of Validation & Compliance Institute (VCI), quality consultants for the pharmaceutical, medical device and dietary supplement industries.
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.
Prior to VCI, 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 is the Sr. Director Global Nutrition, PMO and NPD Process at Mary Kay. She 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 is Senior Partner of Validation & Compliance Institute (VCI) with more than twenty years of experience in the 21 CFR regulated industries. She has written and presented numerous training sessions on quality system elements and best cGMP to corporate clients and at numerous 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 Leitz has a Master of Science degree in organic chemistry from Bucknell University and a Bachelor of Science in ACS chemistry from Hope College.