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Internal quality audits. Section 820.22. You’re supposed to have a process – and be using it.
But the FDA is citing 820.22 violations frequently in Form 483s and warning letters.
The problems tend to break down this way:
If you need an 820.22 game plan or just to tweak what you have, read on…
What would happen if an FDA inspector showed up at your company tomorrow? Think your audit program is ready for prime time? Maybe, or maybe not.
Here are just a few of the comments found in recent warning letters detailing internal quality auditing failures:
FDAnews, in conjunction with medical device expert Dan O’Leary, brings you a quality audit compliance plan to improve systems like yours. Mr. O'Leary's proven blueprint draws from the regulation, the preamble, and recent warning letters to provide a total compliance program
In 90 minutes, you’ll discover how to set up systems and procedures for conducting quality audits that pass FDA muster — plus tips and strategies to assure that audit plans get good, and stay good.
Companies with a quality audit in place will discover secrets of improving their plan and learn what the FDA is focusing on now.
Mr. O'Leary is no 20,000 ft. theorist. He gets into the nitty gritty:
Instructor Mr. O’Leary has more than 30 years of experience in quality, operations and program management in regulated industries, including medical devices and clinical labs. A frequent presenter at FDAnews seminars and conferences, Mr. O’Leary consistently gains high marks from attendees.
An effective audit program is your best defense against Form 483s and warning letters because it will help you uncover and fix problems before FDA investigators spot them. Discover audit strategies that consistently pass FDA scrutiny.
Dan O’Leary has more than 30 years of experience in quality, operations and program management in regulated industries, including aviation, defense, medical devices and clinical labs. Mr. O’Leary is now president of Ombu Enterprises, LLC, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. He has a master’s degree in mathematics, is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt and is certified by APICS in resource management.
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