Episode Thumbnail
Episode 51  |  36:28 min

Lessons to Be Learned From Recent FDA Inspections

Episode 51  |  36:28 min  |  11.07.2019

Lessons to Be Learned From Recent FDA Inspections

00:00
00:00
This is a podcast episode titled, Lessons to Be Learned From Recent FDA Inspections. The summary for this episode is: Something that you might find surprising is the number of medical device companies that are simply not prepared for an FDA inspection. The bottom line is that you should expect to be inspected. Today we’re going to be talking to Mike Drues, the president of Vascular Sciences, about the lessons that companies have learned from their not-so-successful FDA inspections. You can learn from them, too! Some of the highlights of the show include: ● Jon’s story of a situation where a company was completely unprepared for an FDA inspection years after their product went to market. ● The difference between not having the required information and having the required information in a format that’s unacceptable to the FDA. ● What companies can do to prevent problems with FDA inspections. ● The importance of knowing what you know and knowing what you don’t know and knowing the difference between the two. ● Why it’s so important to consider the root cause of troubles with FDA inspections. Many times, the root cause is a tick-the-box mentality. ● Best practices for being prepared for an inspection. ● Why an independent audit might not be an effective way to know that you’re prepared for an inspection, as well as tips on knowing whether your auditor is beneficial. ● Why it’s good to purposely inject a problem into your process to be sure that your quality control system will detect it. ● The importance of taking a holistic approach rather than only looking at issues one at a time.
Something that you might find surprising is the number of medical device companies that are simply not prepared for an FDA inspection. The bottom line is that you should expect to be inspected. Today we’re going to be talking to Mike Drues, the president of Vascular Sciences, about the lessons that companies have learned from their not-so-successful FDA inspections. You can learn from them, too! Some of the highlights of the show include: ● Jon’s story of a situation where a company was completely unprepared for an FDA inspection years after their product went to market. ● The difference between not having the required information and having the required information in a format that’s unacceptable to the FDA. ● What companies can do to prevent problems with FDA inspections. ● The importance of knowing what you know and knowing what you don’t know and knowing the difference between the two. ● Why it’s so important to consider the root cause of troubles with FDA inspections. Many times, the root cause is a tick-the-box mentality. ● Best practices for being prepared for an inspection. ● Why an independent audit might not be an effective way to know that you’re prepared for an inspection, as well as tips on knowing whether your auditor is beneficial. ● Why it’s good to purposely inject a problem into your process to be sure that your quality control system will detect it. ● The importance of taking a holistic approach rather than only looking at issues one at a time.

More Episodes

Past, Present, Future State (and World) of Quality in the Medical Device Industry

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

Addressing the 'Who, What, When' of Quality in the Medical Device Industry

Meet a Guru: Maryann Mitchell

Why Storytelling Matters for Medical Device Companies

A Breakthrough Device that Aims to Prevent Osteoporosis