Top 10 Tips for Dealing with a Consent Decree
Understand that you are probably going to be asked to contract with an expert third party. Carefully select that third party!! They will be your biggest ally or your worst nightmare.
Just because the consulting firm promises you the world, does not mean that they can deliver upon it.
Select people with hands-on compliance experience – in Operations, in the QC Lab, in the Warehouse, etc. Theory is great but will take you only so far when serious questions are asked regarding how to move forward and actual experience on the subject matter is needed.
You have to be ready for a serious situation and know that things will not be better – for a long, long time.
This statement is targeted to senior management and specifically relates to tip #1 above.
There are no easy ways out; no amount of “knowing the FDA” will prepare you for the wrath of putting the FDA into a position to seeking a Consent.
Have a close circle of experts and staff that will be willing to support the upcoming storm.
You may have a cast of thousands that want to help.
Limit the inner circle to those who can make decisions and follow through on the actions needed.
Have open communication to the employees. As best you can perform the task, keep the lines of communication open. People will be worried – and rightly so. If there will be a reduction in force, determine who and when – do this action quickly.
By the way – you may want to consider communications with the outside world as well.
Your clients (and competition) will quickly pick up on the fact that something serious has happened (or you can preempt the news by notifying them beforehand).
Be ready to resolve the issues and also know that you may find more – sometimes, many more issues that have to be resolved.
Getting to a consent decree usually takes some doing. You are now under a microscope – anything and everything that you do will be viewed with an eye on compliance.
Disruptions in your production schedule will happen. Be prepared. Speak to your customers. Do you have stock that can be shipped?
What is the overall impact to all materials? Do you have to recall the material?
Be prepared for some serious training. No the everyday procedural training or annual GMP training. We are meaning the “change your opinion”, earth shattering – better know it well!! – type of training. And this training is for everyone!! Not just the operators or QA – the most senior management at the company/site MUST be involved with training.
Get feedback. Establish a Quality Council and know what data you must have to understand the progress being made.
We have seen good and terrible Quality Council meetings – long, boring, meaningless numbers and charts or to the point reviews of critical parameters and project timelines.
Visit with the FDA. You are in a very bad situation. All of your credibility has been trashed!!
Establish standard meeting times with your district to review your progress. Be open, honest and forthcoming.
Have a procedure on dealing with the project. Yes – you heard it! A project!
The Consent Decree will be a big project – lasting over several years. As an example, we’ve included our internal procedure for you to review.