Dawn Wydner, former FDA Consumer Safety Officer, LCDR, and Managing Expert for YourEncore’s Quality Center of Excellence, is one of YourEncore’s premier subject matter experts in FDA inspection readiness collaborating with clients to improve and innovate their inspection procedures, documentation, and implementation of new regulations. In this Expert Q&A session, Dawn provides valuable insights into the accountability companies must take on when preparing for an inspection by regulatory authorities.
What is the most common observation you have when helping companies be Inspection ready? How would you advise them tackle this issue?
I guess the most common, with the limited number of observations that can be cited, would be the Sponsor Oversight. Specifically, it’s the documentation to show evidence that you are actually taking on that responsibility to oversight.
For example, issue escalation is one of the best examples; identifying the issue and resolving it in a timely manner is necessary, but having that documentation to show that you took all those steps is where a lot of that responsibility seems to be lacking. Normally when I would do inspections, inspection readiness activities, or auditing, I would always look at things from the “so, what?” perspective:
“So, what’s important? What has the most impact as far as patient safety and integrity?”
Then I would take it from there, because there’s a lot of things you can cite people for. But first, you need to ask the question, the “so what?” of it. Escalation issue management is always a big one.
Having the right documentation ready is key, and implementing the inspection readiness mindset from the beginning can prevent any possible doubts at the end.
How has ICH E6 R2 changed the world of Health Authority Inspections?
It can be summed up in one word, really, and that is accountability. Specifically, the execution of your responsibilities. For me, the guidance made things more clear, and it created more accountability throughout the preparation and inspection.
In your opinion how have risk based principles enhanced companies being inspection ready?
Well first, companies have to embrace them; I think that may be the biggest challenge for most companies. I think a lot of companies are still working on it, but once they’re accustomed to the change, they will have more time to build on efficiencies and concentrate on impactful data and efficacy areas.
When companies first started this risk-based approach, I had to remind them, “Don’t get discouraged; you will probably get a lot of observations in the beginning because, even for the FDA, it was a new concept." FDA Investigators had to familiarize themselves with the concept of the new principals until they were fully understood. Soon after, the industry was following the same concept. Acceptance came once the companies and the FDA were on the same page; things started to run much smoother.
How has the sharing of information between FDA and EMA Health Authorities changed the world of Inspections?
Although it has not reached its prime yet, when it has been incredibly beneficial when fully working. I think that it helps the industry by lessening the amount of inspections at any given stage. We've seen where the EMA will come to the US and do an inspection of a company, and therefore the FDA wouldn't have to, even though it was on their list to inspect that sponsor or site. It's a good method.
It gives more of that accountability between each organization as they rely on each other for inspections, and now you can expand the number of inspections you’re going to do because you’re sharing the effort.
I think the challenge may be, for some companies, that you have to make sure you’re inspection ready for both sides. Although some aspects are very similar, there are distinct differences between the FDA and EMA as well.
Is there an optimal time when companies should start to think about being inspection ready?
Definitely - as we discussed before, in the beginning. From the time you are selecting your site, building your protocol, and preparing for the inspection, you need to have that mindset. It's necessary throughout the whole process.
It’s definitely a challenge though; just having that mindset from the start greatly helps in the end. It's kind of like when you do your laundry: if you’re folding the your laundry, and you put it off to the side, then you keep folding and it piles up – now you’re looking for that one shirt, and it would have been much easier to find if you had just put it away in the first place. Having that preparedness mindset from the start can save a lot of time in the end.
Do you feel that companies do a good job on managing CAPAs? If not, do you have any advice?
I think that the efforts are there, but sometimes companies make it too complicated; that’s where they can fall into all kinds of gaps. I definitely think some companies need more experts, or those that really understand the concept. With those companies that have better developed CAPAs and more effective actions, you find that expertise close by.
The biggest advice would be, really, to have specialized people at the ready who are fully trained in CAPAs and understand the concepts of building out a root cause analysis, etc. Otherwise, you may have to just give it to QA, but they’re not specifically trained in it, which can upset the results. They may know the overall concepts of it, but experts on the subject really understand how to build it and get the right actions out of it.
Any final notes?
At the end of the day, there is so much that you can cover with inspection readiness. Every company’s different, big vs small even, that the logistics will be different everywhere. All you can do is have the right people ready to go.