You already know internal quality audits are required by both FDA 21 CFR Part 820 and ISO 13485.
You also probably already know they are a big hassle to conduct.
What you might not know is that they are one of the most powerful weapons at your disposal for preventing 483's and observations.
Why?
Because they are one of the most effective and efficient ways to make sure you and your team are always prepared if FDA or NB decided to show up unexpectedly.
So how do you “establish” the right procedures? How do you ensure your auditor is competent and properly qualified? And what do you do if you find non-conformances?
Join us for this free, 60 minute webinar, presented by our guest Kyle Rose, President at Rook Quality Systems, where he will be sharing with you the answers to all those questions and more.
Specifically, you will learn:
- How to conduct an effective internal quality audit based on process identification, sampling and questioning
- How to plan a internal quality audit and develop an audit schedule
- How to find and use competent and qualified auditors
- Why certain auditors shouldn’t audit certain areas
- How to properly report the findings of your internal quality audit
- How to concisely document non-conformances
- How to determine what needs corrective actions and how to follow up on them
*Note: Limited live seats available.
Who should attend?
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Medical Device Presidents and CEOs
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Regulatory Affairs Professionals and Management
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Quality Professionals and Management
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Clinical Affairs Professionals and Management
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R&D Engineers and Management
About the presenters:
This webinar is being lead by Kyle Rose, a medical device expert specializing in development of efficient Quality Systems for small and startup medical device companies.
As President of Rook Quality Systems Mr. Rose works as a the contract Quality Manager for multiple medical device companies overseeing overall quality strategy and ensuring compliance through documentation and auditing services.
Mr. Rose is a certified quality auditor (CQA) and has regulatory and submission experience for a variety of markets including FDA, CE Mark, Health Canada, and CFDA.
This webinar is being moderated by Jon Speer, founder and VP of QA/RA at greenlight.guru. Jon is a medical device industry veteran with over 18+ years experience, has helped bring over 40 products to market in his career and is an expert at medical device quality system implementations.
