In a few short weeks, Marcus Evans is hosting its inaugural Clinical Trials for Medical Devices Conference in Chicago.
Our #MedDevice guest this week, Keli Hankee, Manager of Clinical Affairs for Biomet Orthopedics, is a featured speaker. Keli will discuss FDA audits and will advise medical device marketing companies how to prepare for them.
Joe Hage: Welcome, @khankee! We met through a mutual connection at Marcus Evans. You will be a panelist at their Clinical Trials for Medical Devices Conference in Chicago on November 17-18.
Keli Hankee: Yes, Joe, I’m looking forward to it!
Joe Hage: Ok, tell us what sponsor audits are about.
Keli Hankee: Well, first I should say that my talk at the Marcus Evans event will focus on sponsor inspections. First, I’d like to tell our audience a little about Biomet.
We are a global medical device company headquartered in Warsaw, Indiana. Biomet manufactures a multitude of devices including dental, trauma, biologics, sports medicine and total joint.
So now, on to your question. A sponsor inspection is conducted at the sponsor’s facility and it can come about for several reasons, the primary ones being Pre-Market Approval inspections and for-cause inspections.
Joe Hage: Great. Tell us how you would prepare for a Pre-Market Approval inspection.
Keli Hankee: Well, the great thing about that type is that you know it is going to happen … eventually. So the best plan is to start early.
Joe Hage: Can we say, no pre-market approvals are ever given without an onsite inspection?
Keli Hankee: I believe it is a part of the formal application process, yes. It is the FDA’s way of verifying the accuracy of the data.
Joe Hage: You were saying you find the TMF is sometimes overlooked and part of your talk will help device co’s better prepare …
Keli Hankee: Yes, for example, you may have data about an unanticipated adverse event (UADE) in the patient file, in the correspondence, in multiple locations … but you know the FDA inspector is going to want that information backwards and forwards.
My talk will focus on getting the information out of your TMF quickly which can make the difference between a happy inspector and a grumpy inspector. That CAN make the difference between a 483 and a verbal observation only.
(The 483 is the list of the FDA’s observations after the inspection which could result in a Warning Letter. See related story: FDALawyers on Regulatory Crackdowns.)
Joe Hage: The PMA on-site audit is the “easy one.” Tell us about those unexpected site visits. How do you prepare for those?
Keli Hankee: How to prepare for the unexpected? Don’t let things pile up, keep your paperwork and study tasks up-to-date, and maybe most important: Show confidence and don’t keep the inspector waiting for the information he/she has requested.
Joe Hage: I’m thinking, the FDA showed up FOR CAUSE!! They don’t dispense auditors for nothing … something’s probably wrong, yes?
Keli Hankee: For-cause inspections can happen due to patient complaints, employee complaints, other companies’ complaints, so it’s your job to convince the FDA there’s no problem here. Or the alternative, yes, there is a problem, we recognize(d) it, and we’re fixing it by doing X, Y and Z … which can sometimes avoid the 483.
To prepare for an audit, look for FDA’s Compliance Program Guidance Manual. It helps you know what to expect in the audit.
Joe Hage: I enjoyed this interview. Keli, any quick advice you’d like to give a company regulatory person reading this?
Keli Hankee: Yes, there is one other thing and it’s a bit of a judgment call. I would encourage leaders to think a little about WHO will be interacting with the FDA inspector for any of your ongoing clinical trials.
Sometimes it’s not the person who is the most familiar with the study. You want someone who is organized, knows your procedures in and out, and can think on their feet!
Joe Hage: Makes sense!
Keli Hankee: In closing, I’d like to thank you, Joe, for the opportunity to discuss this topic with you today.