November 2012 Posts

CAPA Risk Management and ROI

CAPA Risk Management and ROI

Konyika Nealy, Director of Quality Assurance, Pilgrim Quality Solutions

CAPA systems provide a wealth of information regarding the quality of a product or process.  However, few companies fully leverage the power of this tool to realize its positive impact to the bottom line. For instance, it is commonplace for a CAPA to be initiated for each product quality-related complaint regardless of scope or severity. Over time, the system becomes laden with records, of varying degrees of severity, which are often vetted by issuance order rather than priority. As a result, the organization cannot optimally allocate resources to correct events that have the most impact on the business as a whole. So then, how can a company reclaim efficiency and perhaps even streamline the CAPA process? (more…)

FDA: Five Years, Twenty-Six Days

FDA: Five Years, Twenty-Six Days

Mark Crawford

On October 15, the FDA published guidance regarding new efforts to reduce the average total wait time for 510(k) decisions from an average of 150 days in FY 2012 to 124 days in FY 2017. They will seek to do this by hiring more reviewers and investing more resources, both made possible by the Congressional approval of the Medical Device User Fee Amendments of 2012 (MDUFA III) earlier this year. (more…)