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
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Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.
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- Quality management systems
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- Third-party certification
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This training is essential to anyone engaged in planning or conducting internal audits of an organization participating in MDSAP.
Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.
By the end of this training you should be able to:
- Describe an MDSAP Audit and identify criteria used during an MDSAP Audit
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- Calculate audit time and plan an MDSAP Lite internal audit
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Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.
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- Identify Key Articles and Annexes of the EU IVDR
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- Recognize Content of Technical Documentation
- Identify Post-Market Surveillance Reporting and Vigilance Obligations
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Who should attend:
This course is helpful for experienced internal auditors seeking to expand their auditing knowledge of the EU IVDR, for managers of audit programs, and for anyone who will be the subject of or participate in an EU IVDR audit. Delegates should have some internal audit experience and ideally have certified auditor/lead auditor qualifications in QMS audits.
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