The FDA Compliance Crisis
Rick Bollinger, Founder and CEO of Menlo Park Software.
That black line is the industry "FDA Compliance Crisis".
The FDA defines the Official Correspondent as the person designated by the owner/operator of an establishment who is responsible for the annual registration of the establishment and the device listing. The OC also receives correspondence from the FDA involving the owner/operator and any of the firm's establishments.
Are you the FDA Official Correspondent of your company? Then I may be calling you. A great deal of trust and responsibility has likely been placed upon you. I have managed projects for a number of medical device and pharmaceutical manufacturers. The OC was almost always held in high esteem. And, I am sure they understood the paperwork burden I was always under for project operations and regulatory compliance.
After I retired I decided to make the job of project manager easier and better. I would create a system that supported operations, enforced the QMS, captured the collaboration and then generated the paperwork for regulatory compliance.
See the flat black line on the chart?
That flat BLACK LINE on the chart in the picture above shows the problem. The percentage of inspection outcomes with voluntary or official actions required has been stuck at 40% or more for 10 years.
Just click the chart to expand it.
Hi, I'm Rick Bollinger, Founder and CEO of Menlo Park Software. I'm a management consultant with decades of project management experience. Seeing and solving process problems was my day job for many of those years. Now I'm an entrepreneur.
I managed projects in both medical device and pharmaceutical manufacturing. My travel, work, and experience allowed me to diagnose important and hidden problems using statistical analysis, and design process improvement solutions.