{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fc33f476d-ea2b-4216-9b02-620624e15c54","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Is Your Medical Device Company CAPA Happy?","description":"The medical device industry could be more proactive than reactive when managing systemic issues. We\u2019re talking about the Corrective and Preventive Action (CAPA) process. \n\nIn this episode, Jon Speer invites Mike Drues of Vascular Sciences to be his guest as they discuss the importance of the Corrective and Preventive Action (CAPA) process. Is your company CAPA happy? \n\nSome of the highlights of the show include:\n \n\u25cf\tCAPA is a means to formally investigate a systemic issue and properly take actions to prevent it from occurring again. \n\u25cf\tCall it PACA, instead of CAPA: Place emphasis on prevention, not correction. Identify and predict issues and trends before they spin out of control. \n\u25cf\tFDA \u201ctheoretically\u201d defines CAPA by purposefully offering flexible and vague ideas, rather than specific details. Is that good or bad? It depends.\n\u25cf\tData doesn\u2019t lie, companies struggle with CAPA. FDA\u2019s lack of information leads to interpretation. \n\u25cf\tWhen the FDA issues 483s and warning letters, the usual solution is mandatory training to require employees to know and understand design controls.\n\u25cf\tCAPA is an indicator or biomarker of the health of a company\u2019s quality management system (QMS). \n\u25cf\tMetrics should measure the effectiveness of CAPA. Time constraints and root cause determination need to be addressed. Keep asking, \u201cWhy?\u201d\n\u25cf\tCompanies need to go above and beyond to prevent problems. They should review their CAPA process, evaluate efficacy of QMS, and address root cause.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/fdf151ec-6aa7-49e3-82c7-e8cef1f48e01/baf00ee0-051d-4963-924b-b3b28662235f.jpg"}