Does your CAPA process need help?

In 2023 there were 336 483s written toward the Devices industry on the Corrective and Preventive Action (CAPA) system. The focus of these was on procedures not adequately established as well as inadequate documentation of activities (corrective and preventive) by Device firms. These are foundational requirements outlined in CFR 820.100 and ISO 13485 for CAPA systems and …

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My Ki-Musubi: A connection between mentor and student

On 08Mar17 I received an email that I had been dreading getting in my in-box ever since I first found out about the diagnosis. Pranin Sensei (For anyone reading this that doesn’t know, Stanley Pranin was the founder and Editor-in-Chief of was diagnosed with an advanced stomach cancer, one of those things that when you get that kind of news from a Doctor it takes a moment to digest. I know this type of news can affect someone’s life perspective, sometimes even drastically. Not Pranin Sensei though, even when he got the news he remained positive and determined to face this as one of those challenges you face in life just as the many we all face on this incredible journey.