How To Respond To A FDA Inspection And Warning Letter

This Webinar will help you understand the current FDA requirements for IND and IDE application post initial approval to proceed with the clinical trial.

Why Should You Attend:

Anyone in the food and drug business must know the rights of the FDA, the firm and individuals employed by the firm when the FDA, unannounced, appears to conduct an inspection of the facility. This 2-hr webinar will help you understand the right the FDA has to conduct an inspection of upon demand of a facility under FDA jurisdiction, the rights of the firm and individuals when FDA does conduct an inspection.

If the FDA investigator starts taking photographs, what is the best response for the firm to take? May an individual assert his/her Constitutional rights under the Fifth Amendment to questions put by an investigator? How should an individual respond if a FDA investigator appears at his/her private residence at night asking questions about the FDA regulated firm that employees the individual?

All of the possible issues that may come up during an inspection need to be answered before an inspection occurs, and the individuals who escort the FDA investigators must be trained to know what to do. This 120-minute training will give you the necessary information to be fully prepared for an inspection, a FDA 483 and a Warning Letter. The speaker will give you the tools to protect the interests of your firm and individuals, including what to do when a rogue investigator acts inappropriately in an inspection.

Areas Covered in the Seminar:

• The right of the FDA to conduct an inspection of a FDA regulated firm without any search warrant or administrative warrant.
• The scope an FDA investigation can take, which in part depends on which FDA regulated product is the subject of the investigation
• How FDA decides on which firm(s) to inspect.
• What the FDA is required to do upon arrival at the firm to conduct a lawful inspection?
• What the firm's initial response to FDA's demand for an inspection should be?
• What the firm should do to prepare for the inspection, both for the company as well as for individual employees?
• The significance of the “responsible” person in a FDA inspection under a statute that allows for prosecution of a non-intent crime and why individuals at FDA regulated firms should understand how important it is to know what to do and not do.
• What the individuals who escort the FDA investigators during the inspection should do and not do in response to FDA questions, demands, inquiries, and conduct. Consider this an exercise in practical applications.
• FDA 483 list of observations, what it means, how to respond to it in the exit interview and what to do to respond to the FDA 483. Within this part of the presentation the exit interview will be so individuals especially will know how to present at an exit interview.
• What the firm should do to respond to a warning letter to avoid any enforcement action?
• Several hypothetical situations that may well occur during an inspection and determine the correct course of action

Who Will Benefit:

This webinar will provide valuable assistance to the following personnel:

• Compliance/Regulatory affairs professionals
• QA/QC professionals
• Senior management executives (CEO, COO, CFO, etc)
• Manufacturing managers, supervisors & personnel
• Project Managers