Do you use audio-visual streaming during FDA inspection?

SGquality

Quite Involved in Discussions
#1
I wanted to know if any one has used an audio or webcam (or video conferencing) streaming from the Audit Room to the War Room during a FDA inspection? If yes, what was your experience and if no, can this be done?

Thank you!
 
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Marcelo

Inactive Registered Visitor
#2
I've never used video camera for inspections/audits and I'm not sure it would be worthwhile.

Last inspections/audits were multi-inspector/auditor, with several scribes and evaluations being performed at the same time. We did have one scribe for each inspector/auditor, and we used a Google Hangout stream for requests and information sharing. Monitors in the War Room (and other places, in fact we noted that people were just so interested and delighted with this that they simply keep following what was going on during the whole time :)) were on the Hangouts stream, and there's were already plenty of information. I think a video would only make things more confusing (we did have some eyes for when inspector/auditor went out of the room, but they simply sent updates thru Hangouts or WhatsApp).
 

v9991

Trusted Information Resource
#3
a. we will have to notify auditor about the video surveillance / streaming. am not sure if that will be received/accepted well. :read:

b. downside with the whatsapp/hangouts., that these notes would make way to outside world, inadvertently/in due course of time.!!!
 

Ajit Basrur

Staff member
Admin
#4
The use of webcams or audio recording is mentioned in INVESTIGATIONS OPERATIONS MANUAL (see section 5.3.5, on page 37 of 123), and states the following:

Under normal circumstances recording devices will not be used while conducting inspections and investigations. However, some firms are now recording and/or videotaping, the inspection and/or the discussion with management portion of the inspection. These firms should be advised we do not object to this procedure, but we will also record the discussion to assure the accuracy of our records. Occasionally a firm's management may record the serving of an inspection warrant or, in a hostile situation, may want to record everything. In such cases, depending on the circumstances, you may prepare your own recording in parallel with the firm's recording. Do not depend on the firm to provide a duplicate of their recordings.
 
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