Be Prepared

Author: Stacey Homan


It was almost five years ago, but I remember it like it was yesterday.

Whispers started going around the office…”the FDA is here”.  I had just joined the marketing department for a medical device company a short time earlier and we were about to undergo an audit of our marketing materials and procedures.

A month before we had undergone a complete overhaul of our procedures, but would it hold? We were still making small tweaks to the system and now it was going to undergo an intense two-week audit where everything was on the line.  As a start-up you are not afforded many mistakes.

Over the next two weeks we spent hours digging up records from a variety of places.  We had not yet set up an efficient distribution system; everything was located in multiple spreadsheets and reports that needed to be coalesced.  We had a mix of paper and electronic records. We were tracking down marketing materials created years before that were still ‘out there’ somewhere.

Thankfully, we had policies and procedures in place that answered all of the concerns the FDA had and through a lot of late nights, we pulled together the information we needed to avoid a warning letter.   But after the storm died down, I was left thinking: there has GOT to be a better way to do this.  How can we improve procedures the best we can so that this won’t happen again?   How can I make it easy to the reps to not do something that would cause an audit or warning letter but will still help them sell?  Will this anxiety ever go away?

I’m actually a fan of audits (internal ones, not the FDA kind).  They give you a chance to improve and make you stronger.  How prepared would you be if you were asked to produce the last three (3) years of sales and marketing collateral with approvals and distribution records?  You might want to conduct an internal audit and find out.  Personally, I vowed that I would help my company be more prepared if this happened again.

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