8 Things I Learned From Regulatory Audits

My very first regulatory inspection was a FDA audit in late 2007.  News spread that the inspectors were knocking at our door and I have never seen so many people trying so hard to look busy in my life (myself included). Later that afternoon and for the rest of the week my manager sent me to the temporary office trailer out behind the building to train on procedures at my desk. I was just a lowly contract technician at the time, technically not even an actual employee for the company being audited so I guess it made some sense for me to hidden away in an office during a high profile audit. Since that day very early in my career, I have been involved in numerous regulatory agency audits while working for a global pharma company. Having come such a long way, I will share a few inspection lessons I learned along the way for audit success as a laboratory analyst.

So, eight things I learned from regulatory inspections.


1. Be the guy you want to be in a bunker with.  This can be said for a lot of things not just your role within your company, i.e. your relationships with your spouse, business partner, family, friends – everyone you are close with wants to know you have their back when it matters most. The absolute last person you want find yourself alone with in your bunker is someone you don’t trust. Period. Imperfections and bad habits tend to be immensely magnified in high stress situations. You want that person who would dive on a grenade for you because you would do the same for them. Stay late to verify data, check expiration dates on every reagent, heck even check reagents for other departments. Take responsibility for mistakes and quickly correct them. Sweep the floors, even that spot behind the door you don’t want to crouch down to get. Every day try to be that person, especially during an audit.

Be this guy.

2. Be the source. Google and Yahoo are wildly successful because they do just that – provide a lot of information without asking for any credit as they give you countless pages of information. If an auditor is looking for something, i.e. a data sheet from an assay run three years ago, a random protocol written by the employee you replaced, or an Excel graph trend of every environmental isolates cultured from the plant since the beginning of time – just find it for your manager and move on. Think on your feet and anticipate where the auditor is going and future questions that could come up next.  Offer as much information to your manager or director about to head into the audit room. Make them look good, the more prepared they are the better. Do this without taking any credit for your own. Become the directory of everything related to your department. OWN the department.

3. Be fast, be accurate, and have a great review system. It is essential to have a system in place for all aspects of the audit. From runners, to review teams, inspection coordinators and those running the staging rooms. When they ask for x, y, z  be able to produce results fast and at a high quality.  Set yourself apart by producing great reports. Have a system in place ahead of time.

Review Everything

4. Networks are important. The biotech world is pretty small. If you have been in this field for any amount of time chances are you know somebody working at another company. With a strong network, you can get tipped off before they even show up at your doorstep. I’ve seen this happen before where two well known inspectors were making a visit to a company about a half-hour away and a colleague at that company politely made a call down the road to notify them that so & so were at their place and chances are they are heading your way next. Always know what is going on around you.

5. Have a profile of your inspectors.  Pet peeves tendencies, likes, dislikes, how they like their coffee or even their favorite dish. Think of it like when you are hosting guests over for dinner except your guest can shut down your operation if they don’t like the way you prepare your meatloaf. It may sound like minutiae but inspectors pick up on attention to detail. *Update* Taking this idea a step further, when the FDA shows up, you should probably have someone Google your inspector.  I would have the regulatory team go ahead and purchase all the 483’s that this inspector has issued previously. Like a football coach watching an opposing team’s game film, I would want to know my inspector’s tendencies from their past few inspections.

6. Build a rapport with the inspector. Like any good parent, teacher, or boss, an auditor has their BS radar on high alert at all times. Just like you meant to clean your room, your dog ate your homework, and you have a really bad stomach bug on the first perfect weather day of summer – auditors are trained to pick up on anything that might have the slightest hint of exaggeration or fuzzy math. Avoid mumbling, talking with your head down, and my personal favorite, the nervously shaking uncontrollably routine. Make strong eye contact and be confident in your answers. Being honest and straightforward goes a long way in this industry.

7. Prepare. You can personally prepare for regulatory audits and it probably should be a major part of career training. Like a basketball player practicing a contested 3-point buzzer-beater or a quarterback running the two minute drill, it makes a great deal of sense to practice the high stress situations before they ever happen. Two years ago I got my friends in the industry to start practice grilling each other like we are in an inspection room. I know this is completely un-sexy and a NERD alert is sounding somewhere but considering how an inspection outcome can make or break a career I see this as a little insurance to help ensure you can get things done in those high pressure moments. Make yourself really sweat and get the adrenaline flowing.

Adrenaline is flowing.

Have there been common requests in past audits? Think of your departments weak spots may be. Write them down and work to fix them. If its your job to produce a data report, practice ahead of time. Set a timer and have someone verify the accuracy of your report. Sometimes auditors from smaller countries just want to pick at the low hanging fruit and give you a real good one-over. Working in the restaurant business as a college job, I learned if you can’t keep the bathrooms clean then guests will wonder what is going on in the kitchen. Same thing with regulatory auditors, if you can’t do the small things right like logbook entries, appearance cleaning, and following basic procedures – doing exactly what you say you do, then chances are you don’t do the big things right as well, like I don’t know – producing your drug!

8. Look good. I hear a lot of griping from co-workers about having to dress business casual for an inspection. The complaint is usually something like “well shouldn’t they see us as we are dressed everyday?” The answer to this is simply no. Like the dinner guest analogy from before, you don’t want to look like a slob when your guests are coming over. Leave the sweat pants at home for a day, suck it up and throw on a dress shirt and some nice pants. Keep it simple, you don’t have to go over the top for the fictional “Regulatory Inspection Best Dressed Award.” Although, come to think of it, I would look pretty damn good testing bioburden in a tuxedo.

Overall, it is important to not forget, inspections are just part of the process and can be good for a company. Turns out the threat of extensive fines, closure, legal action, and 483’s tend to be more often than not the perfect motivation to fix anything that may be less than ideal and do things the right way. Follow these tips and hopefully you’ll be smooth sailing through your next audit.

Feel free to share some of your own tips for getting through an inspection in the comments section. I would love to hear from you.

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