30 min listen
Auditing the Auditor
FromGlobal Medical Device Podcast powered by Greenlight Guru
ratings:
Length:
41 minutes
Released:
Jan 6, 2023
Format:
Podcast episode
Description
For some people, audits are terrifying. But today’s guest says you need to learn to love the audit process, and she shares information that can help you do that.Sara Adams is a Medical Device Guru at Greenlight Guru. Medical Device Gurus are part of Greenlight Guru’s “Guru Edge.” Medical Device Guru’s help customers onboard to their new software and guide them through the various regulatory requirements and challenges unique to MedTech companies and Medical Device Professionals.Listen to the episode to hear Sara share some of her wisdom about audits. She talks about what happens when you don’t accept the finding of an audit, the different types of rules and approaches to different kinds of audits, and the kinds of problems she consistently sees from people when they’re learning to do audits. She also shares details about her own first audit!Some of the highlights of this episode include:Sara’s background and experience with auditsHow Sara trained other people to auditHow to build a culture of collaborationSara’s first audit experienceWhat the process of negotiating an audit finding looks likeWhat’s unique about each auditThe partnership in a supplier auditConsistent problems people face during audits and how to overcome themWhat’s important to know about getting ISO certificationMemorable quotes from Sara Adams:“In an internal audit, you need to avoid a conflict of interest. Like I don’t need to be auditing my own work.”“Quality is everyone’s responsibility and not just the quality department’s.”“We all have a first day. Everybody has a first day.”“Never look at something as just a checkbox.”Links:Sara Adams LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru
Released:
Jan 6, 2023
Format:
Podcast episode
Titles in the series (100)
Tips to Help You Prepare for an FDA Inspection: On today’s episode, we’re introducing the newest addition to the greenlight.guru team, Jessica Lyons. Jessica is a 2007 graduate of Rose-Hulman Institute of Technology and has worked in the medical device product development for nearly 10 years. She ... by Global Medical Device Podcast powered by Greenlight Guru