{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F8cae9dd6-e61a-4914-ae6b-6efe6240a7bf","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"<iframe style=\"width: 100%; height: 200px;\" title=\"Challenges with Applying Risk Management Throughout the Manufacturing Process\" frameborder=\"0\" scrolling=\"no\" allow=\"clipboard-write\" seamless src=\"http://player.captivate.fm/episode/8cae9dd6-e61a-4914-ae6b-6efe6240a7bf\"></iframe>","title":"Challenges with Applying Risk Management Throughout the Manufacturing Process","description":"Today we\u2019re going to be taking the topic of risk management to the next level. We are talking to Jim Gianoutsos with Regality Consulting. We are going to explore some of the challenges with a company\u2019s approach to manufacturing processes as they apply to risk management. \n\nSome of the highlights of the show include:\n\n\u25cf\tInformation about Jim\u2019s background and about Regality Consulting. \n\u25cf\tThoughts on how risk is sometimes a box to check rather than an integral part of every discussion and every decision that\u2019s made throughout the manufacturing process.\n\u25cf\tWhy the adoption of ISO 14971 has been so problematic for medical device companies.\n\u25cf\tWhy it\u2019s important to consider risk management before planning design.\n\u25cf\tConsiderations to keep in mind when outsourcing or getting components and materials from other organizations.\n\u25cf\tThoughts on validating processes and sampling based on risk assessment and management. \n\u25cf\tAn example that Jim has seen regarding a lack of sufficient risk management: the takeaway is to address risk management now; don\u2019t wait until you get a warning letter.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/b40b6448-34d1-4832-9b8d-311fb1492ca9/f5b8d64c-c785-44a0-8301-3f3f729a70e7.jpg"}