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Tips & Pointers for Effective Internal Quality Audits with Kyle Rose
Episode 267th November 2019 • Global Medical Device Podcast powered by Greenlight Guru • Greenlight Guru + Medical Device Entrepreneurs
00:00:00 00:20:55

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Internal audits might be inconvenient and a bit nerve-wracking, but they’re also educational. The objective of an internal auditing program is to help you understand your processes and learn about opportunities for improvement. It also protects your company and ensures that your procedures are on par with the regulations. Today’s guest is Kyle Rose, the CEO of Rook Quality Systems. Rook is a company based in Atlanta which helps medical device companies in the pre-marketing and marketing phases. Kyle specializes in structuring internal audit program and today provides tips and pointers to our listeners. Topics you’ll hear about today include: - Best practices for effective internal audits. - Why an audit plan is necessary and helpful. - Things companies can do to make their internal audits more thorough than an FDA audit. - Tips for startups who have not yet implemented an internal auditing procedure. - Why it’s important not to outsource all of the tasks necessary to conduct the internal audit, nor to rely on one person to handle the entire internal audit. - How Rook Quality Systems can help medical device companies with the internal audit process.




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