FDA may inspect firms at a reasonable time, within reasonable limits and in a reasonable manner. Whether or not an inspection appears reasonable depends on a person’s point of view. FDA investigators rely on well established procedures and techniques. In an FDA investigator’s mind, there really is no mystery about what happens during an inspection or why. The fact is though that many firms do not understand how an inspection is conducted and what follow-up regulatory action, if any, may be looming on the horizon.
Understanding the common elements of inspections can dispel some of the myths built up around them. For FDA, inspections are a reality check, a snapshot, of a firm’s compliance with applicable FDA requirements and, to some degree, conformance with FDA guidance.
Why should you attend:
When FDA shows up at your front door to announce an inspection, what do you think is going to happen? More importantly, what are you going do?
An ex-FDA investigator will conduct this webinar to share an “insider’s” perspective about inspections. You may find answers to the question, “What is he thinking?” when the investigator starts digging through the complaint files or starts reading memos on lunch room bulletin board.
Firms with an established FDA inspection protocol typically understand what happens during an inspection and why an inspection should be managed carefully. Many firms do not understand FDA inspections or may not have given them serious thought. That type of firm seemingly plans in a panic.
How you manage an FDA inspection and the outcome of an inspection can have a material impact on the firm’s business, if not survival. The core direction of FDA inspections is to determine a firm’s level of compliance with FDA requirements and collect evidence to use against the firm for failing to comply with any regulatory requirement. The negative inspectional outcome can be costly in terms of money, lost business, consent decrees and the prosecution of the firm’s executives. Every FDA inspection concludes with a warning to that effect. How you manage an inspection can significantly affect the outcome. Prior knowledge about what happens during an inspection can serve you well and help you avoid trouble with FDA
Areas to be Covered:
FDA’s overall inspectional program
FDA inspection preparation
FDA regulatory Compliance Programs
Investigations Operations Manual
Who will Benefit:
Note: All of the following areas are subject to FDA inspectional coverage
Senior Executives who are ultimately responsible for the firm
In-house legal counsel
Senior managers for Operations
Senior managers for Marketing
Regulatory Affairs Managers
Quality Assurance Managers
Manufacturing and Design Managers