Device History Records Sec. 820.184: FDA Inspectors Are Reviewing Them Carefully — Are You?
Product Details
- How to avoid warning letters
- What the regulations really require and how they are typically applied during inspections
- Easily overlooked but vital DHR requirements
- How UDI will change your DHR
- What labels are really required in the DHR and why
- The real role of “designated individual” and what you should look for when you review the DHR
- Why you need to perform a gap analysis of your company’s current procedures and how to do it most efficiently
- The linkage between the Device Master Record (DMR) and the Device History Record (DHR)
- How to use the Quality System Record (820.186) to reduce DMR and DHR complexity
- How acceptance activities support the DMR and DHR
- How to properly document final acceptance activity to speed product release
The Right Information from a True Subject Matter Expert
Too many companies fail to understand the details and importance of DHRs. As a result, companies are being tripped up during FDA inspections, which leads to warning letters. This presentation’s speaker and leader, Dan O’Leary, has developed a DHR compliance plan that will substantially improve your efforts to avoid DHR warning letters.
Mr. 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. He 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.
In Only 90 Minutes, a Complete Guide to Device History Records
This is the ideal time-saving presentation for device manufacturers, medical device companies and contract manufacturers. It’s a must-attend for medical device manufacturing executives, QA/QC managers and directors, production managers and supervisors, quality inspection and test managers, supply chain specialists, process development staff, compliance officers, training managers and all regulatory affairs and compliance professionals.