The Cincinnati Chapter of Xavier Health came together on January 8, 2014 to discuss the ROI of Regulations and Quality. The breakfast meeting was free of charge for Cincinnati-area pharmaceutical, medical device and regulatory professionals. All left with a better understanding of the cost for poor quality.
The speakers delivered presentations that touched on the factors that affect your ability to make quality or regulatory decisions and how you deal with them. Steve Niedelman, former Deputy Associate Commissioner of the FDA, now Lead Quality Systems and Compliance Consultant, King & Spalding, explained what companies need to understand today to avoid FDA enforcement action. The audience took good notes as Gina Brackett, FDA Cincinnati District Compliance Officer joined the discussion and shared the top three red flags that tell the FDA a company is out of control.
When asked if there is one thing she wished industry could improve, Gina indicated that she wished companies had the mindset that quality is part of everyone’s job. She further explained that the “Quality System Regulations help you make good product and are good business.”
The number one red flag that tells FDA if there are serious compliance issues with a firm is when systemic issues signal a breakdown in the culture of the company. Culture is so hard to change, that companies often have to change the management team to see a difference. All four speakers echoed this sentiment as the key ingredient to a successful business in the medical device and pharmaceutical industries.
A second red flag is related to product design. Instead of addressing problems, complaints and non-conformance, companies will come out with the next model and perpetuate the poor design. Not recognizing when to recall a product is an area of great concern.
Lastly, a third red flag that a company is in a state of serious non-compliance is when they are not assessing streams of data from all sources. In the device industry, examples would include not including service records and acceptance of non-conformance as part of the Corrective Action Preventive Action system. Is your risk assessment based on the right data? And don’t forget “you don’t know what you don’t know,” which could have serious consequences for the patients you serve.
Advice from the day: spend your time preventing issues, instead of relying on attempts to catch issues.
A newcomer to Xavier Health, Jessica Zeller, Senior Counsel at Procter & Gamble, earned high marks as she shared challenges she faced during her former role at the FDA where she was responsible for litigating pharmaceutical consent decrees.