Creating, Staffing and Managing an Inspection War Room Your First Line of Defense
$527.00
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We’ve all heard the basic “How to Prepare for an Inspection” presentation. And we’ve heard your cries of “more detailed presentations, more specifics” on how to manage inspections.
On Thursday, Nov. 8, FDAnews presented one of the year’s most anticipated — and detailed — webinars on inspectional preparedness. And now you can listen with this special encore presentation.
Too often, firms slap together what is essentially the central nervous system of their inspections. There’s no forethought into the who, what, where, why and how behind every good inspection is a good war room.
Recently, during a drug company inspection, a heated argument broke out — in front of an FDA inspector — between two employees who disagreed on their own company procedures. Don’t let this happen to you.
If you can’t confidently answer the following questions, register now for this special encore presentation.
- Who is going to be in your war room and how should you determine assigned roles and seniority?
- Who is responsible for guiding the FDA around a site? FDA investigators hate the “hordes” that follow them.
- What kinds of information should you provide — and what’s off limits to the FDA?
- What is considered privileged material or trade secrets and can you back your position up?
- If the FDA asks about the price of a product or what you pay for a good or service, are you going to respond?
- Photos within your facility? Yes or no? Either response has serious implications.