FDA Inspection Readiness for Dietary Supplements

Preparing for an FDA inspection for dietary supplements will help you avoid getting a warning letter and the regulatory and business consequences that come with it. Establishing a relationship of professional trust between you and the FDA requires preparation well before the inspection, thoughtful management during the inspection and thorough follow-up after the inspection.

This course walks you through the entire process. Participants will learn who should be on the company’s inspection teams, what roles they need to prepare for and how employees should act when questioned by inspectors.

At the end of the course, you will know and understand:

• The regulatory context for FDA inspections of dietary supplements
• What to expect during these inspections
• Business consequences if the inspection does not go well
• Critical steps to accomplish before any inspection ever takes place
• How to effectively manage the inspection process and any issues that arise during the inspection to optimize the outcome
• How to establish a relationship of professional trust with the FDA and the advantages
• Essential elements of follow-up activities to ensure a positive ending to the inspection and to position your company for the next one

This dietary supplements FDA regulatory training is suitable for:

• Management
• Manufacturing
• Quality control/assurance
• Packaging
• Laboratory operations
• Auditing
• Legal
• Regulatory affairs

Course instructors will be selected from the following:

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.

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.