Resources

For some companies, manufacturing is a crapshoot. There is little basis for confidence that the right equipment, materials, components, people, and records will be at the right place and the right time to begin manufacturing. And once manufacturing starts, a crystal ball is as good as anything to divine whether the product batch will be […]

The FDA has spent much of January focused on American medical device issues. In particular, they have been reviewing the regulatory status of several classes of medical devices already on the market. The latest segment of the industry to be subjected to FDA scrutiny is the manufacturing of external defibrillators. External defibrillators have gained a […]

The ease of application development afforded by the extensive community surrounding portable devices like the Apple iPhone/iPad has led to a surge in medical device-like apps being released for smart phones and tablets. An article published by Siren Interactive quoted a MobiHealthNews study that found more than 7,000 medical apps available for the iPhone in […]

I remember when I was a freshly minted executive taking a window tour of the manufacturing facility. While listening to a staff member talk about the operation, I idly traced my fingertip on an ever-so-slight mar on the finish of the corridor wall, as I was lost in thought. Little did I know the chain […]

I’ve come to the conclusion that compliance with the FDA Current Good Manufacturing Practices (CGMP) is just as much about company culture as it is about anything else. A corollary to this is that resolution of regulatory compliance problems is just as much about organization transformation than anything else. I have divided companies with significant […]

If any part of your life includes trying to figure out how to work smarter with the FDA, this is for you.  Here’s our list of the top 40 31 online destinations on the FDA and some of the key industries it regulates.   We applied only one criteria to make it on this list:  free, up-to-date, […]

Of course, I understand that everyone in the organization owns “quality.” Much like safety, everyone has responsibility to follow safe practices and call attention to potentially unsafe conditions. However, there also is a Safety Department that is responsible for establishing safety policies and procedures, as well as conducting periodic safety inspections. They report the safety […]

The FDA had sent one of their best and toughest inspectors. The facility was located in Costa Rica. I had been sent there from the US to help a sister company with a pending inspection. I had arranged a dinner the night before the start of the inspection at a (supposedly) nearby restaurant in order […]

FDA’s touches the lives of every American at least 6 to 10 times each day. The agency oversees 80% of the nation’s food supply, all of animal/human medical cosmetics and products, and almost all radiation-emitting devices. Put all that together, the agency is responsible for about 20% of all consumer dollars spent in the United […]

New heads of Quality Assurance come into pharmaceutical companies all the time for various reasons. If you are the new head honcho of quality, hopefully you were able to get some sense for the reasons for the vacancy during the interview process. I recognize that this is not always easy in an interview situation. I […]