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Video instructions and help with filling out and completing fda form 3962
I want to welcome everyone to this FDA compliance presentation what we're going to be talking about here today are FDA inspections practical guide it's given by compliance insight we're going to be talking about how to get ready for an FDA inspection what to do before during and after that event so you can become successful in your job and make your company successful preparing for the audit first things first with this I can tell you you should always be prepared for an audit you should not have these ABS and flows of audit preparedness where you have to at the last minute run through and do everything quickly I can tell you it becomes very apparent when people do that I can see fresh paint over rust on equipment or on walls I can see documents that were just signed or signed very recently and they're all signed within a week of each other it becomes very apparent that hurried work was performed and this tells me that you are not really operating in a state of compliance continuously you are just showing me this dog-and-pony show so I get a good feeling and then after I'm gone you go back to just operations as usual now that being said last minute cleaning organizing certainly expect it I fully anticipate people will go through and and clean things up they'll put things away I I'm not talking about that I'm talking about the major types of things just getting stuff to a state of compliance at the last minute is a bad idea most inspections from the FDA certainly not announced you you may have some idea that they're coming in if you filed some type of application or if you've had some type of recall or a serious complaint but most of them they just come in for an inspection general GMP inspections are performed approximately every two years there's some risk-based approach to that it could be something even longer than that if you're in compliance if you've got a low-risk type of product it go out probably farther than that but if you're really risky and a product parentals something that's very tough to make expect it approximately every two years pre-approval inspections like I said if you filed some type of application expect the FDA to come in to look at your process and certainly if you have a recall serious complaint expect for cause inspections to follow up on those issues some general things to keep in mind preparing for the audit a place for everything and everything in its place this comes from a an old five s type of program if you look that up on the internet you'll see it's a sort of a maintenance type of program it means everything is put in a proper place it it's organized and it's put away it gives the sense visually that things are in control and that's my important.