For FDA Inspection Readiness, Accountability is Key
Dawn Wydner, former Food and Drug Administration (FDA) Consumer Safety Officer, LCDR, and current Managing Expert for Advarra’s Quality Center of Excellence, is a premier subject matter expert in FDA inspection readiness programs. Wydner has successfully collaborated with clients to improve their inspection procedures, documentation, and implementation of new regulations, emphasizing accountability is key for FDA inspection readiness. In this blog, Wydner provides insights for organizations preparing for an inspection by regulatory authorities.
What is the most common observation you have when helping companies become inspection ready? How would you advise them to tackle this issue?
Vendor oversight: Specifically, documentation demonstrating sponsors and contract research organizations (CROs) are actively participating in vendor oversight management. For example, issue escalation — identifying and resolving issues in a timely, standardized manner — is necessary, but documenting these steps is critical for inspection readiness investigators. Auditors and investigators look closely at the impact, the “so what is most important?” perspective, understanding what largely impacts participant safety and integrity. Having the right documentation ready is key, and implementing an inspection readiness mindset from the beginning can proactively mitigate risks at the end.
How has ICH E6 R2 changed the world of health authority inspections?
For FDA inspection readiness, accountability is key. Specifically, the execution of your responsibilities. This guidance clarified the accountability required for successful outcomes from health authority inspection readiness programs. Sponsors and contract research organizations (CROs) received clear preparation and inspection guidelines.
How have risk-based principles enhanced preparation activities for companies becoming inspection ready?
Well first, companies have to embrace them; it is the biggest challenge for most. A lot of companies are still working on adopting risk-based principles, but once implemented and integrated throughout the organization, additional time and resources are now free to build on efficiencies, focusing on impactful data and efficacy areas.
An important reminder for organizations is not to get discouraged by the volume of observations from agency investigators, as this approach was a new concept for the FDA as well.
How has sharing information between FDA and European Medicines Agency (EMA) health authorities changed the world of inspections?
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 to inspect 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 because sharing this information leverages responsibility for accountability between organizations.
For some companies, ensuring their preparation activities include requirements for both sides may be challenging. Although some aspects are very similar, there are distinct differences between the FDA and EMA.
Is there an optimal time when companies should start to think about being inspection ready?
Definitely — in the beginning. From the time you are selecting your site, building your protocol, and preparing for the inspection, you need to have this mindset. It’s necessary throughout the whole process.
It’s definitely a challenge though; having a preparedness mindset from the start can save a lot of time in the end.
Do you think companies do a good job on managing corrective and preventative action (CAPA) plans? If not, do you have any advice?
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 quality assurance (QA), but since they aren’t specifically trained for this, it may upset results. They may know the overall concepts of it, but subject experts really understand how to build it and get the right actions out of it.
A successful health authority inspection readiness program largely depends on a proactive and comprehensive approach. Companies embracing their responsibility for vendor oversight, adopting, and implementing updated regulations demonstrates their organization’s commitment to accountability, participant safety, and integrity.