Preparing for and Managing FDA Inspections

Why Should You Attend:

If you are looking for answers to these questions, you would certainly benefit by attending this seminar on managing FDA inspections:

• How can your company be prepared for an FDA inspection?
• How should your company respond to a 483 or warning letter correctly the first time without hiring a costly law firm?
• What can an FDA inspector legally ask for during an inspection and what can you refuse to show the investigator?

Well, the answers to these and many, many more typical questions are now available in a simple to understand yet detailed training session designed to help manufacturers of FDA regulated products prepare for, manage, and follow up on inspections.

Areas Covered in the Webinar:

• Define the steps necessary to prepare for an FDA inspection
• Discuss details surrounding the management of inspections from announcement to close out meeting
• Offer responses to FAQs regarding typical inspector requests during inspections
• Define the methodology for responding to 483 and warning letters
• Discuss common pitfalls to avoid during an inspection

Who Will Benefit:

This course will provide valuable assistance and guidance to all regulated companies (pharmaceutical, biopharmaceutical, biologics, medical device etc) that are preparing for FDA inspections. The following job titles/ positions will benefit from attending this seminar:

• Internal Auditors
• Regulators
• Legal Departments
• Compliance Officers
• Validation Managers
• QC Managers
• QA Managers
• Facilities and Engineering Department Staff
• Compliance Consultants
• Senior Management

Instructor Profile:

Jonathan M. Lewis, has over 22 years’ experience in the areas of quality control/quality assurance (QA/QC), manufacturing, regulatory affairs, validation, and project management in both industry and consulting roles. Mr. Lewis has experience in the medical device, diagnostic, biopharmaceutical, pharmaceutical, cosmetic, nutritional supplement, food, and animal feed industries.

Prior to founding Reliant FDA Experts (Reliant) (ABC), LLC, Jonathan worked for KMI/PAREXEL, a regulatory compliance and validation consulting firm, in increasing roles of responsibility from an entry-level Validation Engineer to an Associate Director of Consulting. He has worked at RPScherer (Cardinal Health), a contract and proprietary solid oral dose pharmaceutical manufacturing facility, as the QC/Validation Manager. In addition, he has worked at Telectronics Pacing Systems, a medical device manufacturer, in the Sterility Assurance Laboratory.

Topic Background:

Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act which are codified in Title 21 of the United States Code. However, the language in the law and regulations is often very vague and difficult to interpret. Hence, FDA inspections often result in observations and compliance actions that cost manufacturers and marketers of FDA regulated products hundreds of hours and sometimes millions of dollars to address to the satisfaction of the agency.

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