Speaker 1: Thank you everyone for joining us today for this segment of our five minute dosing training program and obviously behind the video that you see here I'm going to be talking about success with an FDA inspection and I don't by any means want to signify that it takes a lot of hard work and you're hammering things out but I can tell you it does take quite a bit of effort and it is forged by fire for a lot of us having gone through successful and unsuccessful audits and that's just part of experience. So I'm going to talk to you today, I'm going to start with a story, I'm going to talk to you about a moderate size firm in the United States and it was their first big product on the way, setting the tone for this, money was okay but it wasn't bottomless, pressure was on by the company to have a big splash, get this product approved, get it approved on time, get out there, management was planning for this big thing. So the FDA inspection, they were looking at it, who would be involved with this inspection? Obviously you have to have some consideration, who's going to talk about the product, who's going to talk about the facility, who's going to talk about how your controls are in place? You have to have everything available and bottom line, you have to demonstrate compliance. So set the tone for what we're going to discuss here, getting ready for an inspection, which didn't go that well, mainly because of this page that I copied out of a white paper written by Compliance Insight, talking about the cycles of getting ready for an inspection. It goes up and down, up and down, the typical company will look at things saying, we have to be ready for the inspection, we have to get things all looking nice and very compliant and then after the inspection, then you can go back and do your work. That's a problem and it becomes very, very apparent in this particular situation because it was very readily viewable when you started looking at say SOPs, that they were all done within a period of about the last two months prior to the inspection. Everything had been updated quickly and without much thought and you could look at the change controls and actually some people had written as part of the justification for the change that preparation for FDA inspection. That was a signal to the FDA that no one really looked at these things until they were coming in. Other things you could see, people were getting caught up on their training, you could readily see paint was put on things, fresh paint on items, things were cleared up, cleaned up, it was all in a place where you could tell they were doing their best to put on their best face for the FDA and that's fine and I understand that, but you've also got to understand you've got to operate in a very good state of control and compliance every day. It is not just put on the show and when the FDA leaves to come back and just basically go back to work the way you used to do it. That doesn't work. That being said, I want you to think about what are GMPs? What are these things? You've got all these little booklets, you've got all this training, you've got all these webinars, all these conferences, GMPs, GMPs are a very simple type of thing. It's a system given to us by the government to ensure products are consistently produced and controlled according to a quality standard. Whatever that happens to be, we have to be consistent with that. It's designed to minimize the risk involved with any type of operation and I always tell people it all boils down to one word. That one word, control. Without that, you have nothing. Everything is out of control. It's no control. It's lack of any type of control. You've got to think of it in that aspect. Thinking of your company and the way the FDA looks at it and systems, they break it down into six systems. We hear complaints and say break it down into three systems. It's down here on the bottom of this where I talk about your company consists of a work system, the workplace, and the workforce. As you look at your company and you think about your work systems and workplace, you've got to think about how do I plan, how do I do things, how do I study things, and how do I act on that data? Your workforce is a totally different approach. You have to be able to train them. You have to be able to audit what they're doing and then you have to coach and mentor them. You can't just train, audit, and find a problem, go back and train, find the problem, go back and train, and ad nauseam over and over again. You have to be able to coach and mentor people. There's a point where a person either misconstrues what they're doing. They don't think it's possible to do it that way. They think there's a better way. Whatever it is, you have to understand that training is not that point where you can have a person that thinks they can do it a better way to train them out of that. That's a thinking problem. With all that being said, I want you to think about this as you get ready for an FDA inspection and to have your success at that inspection. I want to thank you for your interest in watching this. If you are getting ready for an inspection or if you'd like to see this type of presentation given in a fuller length type of presentation, please give us a call. Contact us. I've given you various contact points here. We are here to make it work for you. If you contact us or contact someone else, just get a partner in this. Make sure your success is guaranteed. Don't go with this alone. Even if you're an old pro at it, talk to someone, go through it, brush up on it. There's always a point to learn, and that's a two-way street for us as well. With that being said, I appreciate your time and interest in this, and good day.