Hardware Podcasts

Does Your CAPA Process Need a CAPA?

Global Medical Device Podcast · 24 Aug 2022 · 51m · Episode 277

What this episode covers

Mike Drues, president of Vascular Sciences, joins host Jon Speer of Greenlight Guru to discuss why Corrective and Preventive Actions (CAPA) remain the number one reason for FDA 483 observations and warning letters. They analyze specific regulatory citations, such as failure to initiate CAPAs for systemic complaints and lack of documentation for non-initiation, to highlight common quality management system failures. Drues argues that companies must move beyond rigid metrics like closure time and instead test their CAPA efficacy through proactive 'fire drills' to ensure robust root cause analysis and prevention.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, Vascular Sciences
Also
FDA, ISO 13485, 21 CFR 820

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