16th Annual Medical Device Quality Congress
8:00 a.m. – 8:30 a.m. |
Registration and Continental Breakfast |
8:30 a.m. – 12:00 p.m. |
Correction and Corrective Action — Dissipate the Fog of Confusion Correction and Corrective Action work together as improvement tools for products, processes, and the QMS. They are powerful techniques that, when applied correctly, can help eliminate problems and reduce cost. Each technique uses a separate process; the two different processes link together to achieve their goals. The device manufacturer can develop any process steps as long as they include the required elements from QSR and ISO 13485:2016. Of course, the manufacturer must follow the process steps; this is an often cited problem. Unfortunately, there is confusion about the requirements. As a result, there are often 483 observations or MDSAP audit nonconformances. In fact, warning letters cite §820.100 more often than any other section. Instead of being an efficient improvement tool, correction and corrective action can become another source of problems. The solution is to understand the correction process, the corrective action process, and the associated regulatory elements. This presentation lays out compliant process steps and illustrates common problems using examples from warning letters. The presentation also incorporates QSIT Inspectional Objectives and MDSAP Audit Tasks. As improvement processes, both correction and corrective action utilize quality tools. The workshop describes some of the tools available and connects them to the process steps. Participants learn how to develop and implement correction and corrective action processes that are easy to use, efficient, and effective. Workshop leader: |
Pre-conference | Day 1 | Day 2 | Post-conference
"Very pleased that most speakers were directly from industry, either FDA or corporations. Good to hear directly from the source.”
— Rossellen Miller, Product Development Quality Engineer
Terumo Cardiovascular, Inc.
“Topics were current and well presented.”
— Scott Tabb, Supplier Quality Manager, Medtronic
Surgical Technologies
Who will benefit?
- Quality Assurance/Quality Control
- Manufacturing and Contracting
- Supply Chain Management
- Risk Management and Product Lifecycle Management
- Executive Management
- Regulatory Affairs
- Research and Development
- Compliance Officers
- Consultants/Service Providers