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.
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.
*Note: Limited live seats available.
Medical Device Presidents and CEOs
Regulatory Affairs Professionals and Management
Quality Professionals and Management
Clinical Affairs Professionals and Management
R&D Engineers and Management
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.
greenlight.guru produces beautifully simple Quality Management Software that helps medical device companies bring safer devices to market faster while reducing risk and ensuring compliance. Visit our home page to learn more.
Rook Quality Systems provides specialized and custom consulting services for all classes of medical devices. We work with you to outline your quality and business goals to develop innovative and efficient practices that improve compliance and profit. To see a full list of the services Rook offers you can go here.