|By PR Newswire||
|July 31, 2014 10:00 AM EDT||
SAN DIEGO, July 31, 2014 /PRNewswire/ -- During the last few years, there has been growing attention given by the Food and Drug Administration (FDA) to the implementation of corrective and preventive actions (CAPA) at medical device and pharmaceutical companies. Inspections and actions by the FDA are as concerned about the process for identifying and correcting an issue and making sure it doesn't happen again, as it is about the issue itself.
Recently, top medical device and pharmaceutical executives attended the second annual Sustaining Effective CAPA Systems Conference, to hear thought leader, Debara Reese, Vice President Quality and Compliance for Maetrics, a leading global compliance consulting firm, discuss best practices and common CAPA pitfalls at the exclusive conference in San Diego.
Reese set the tone for her talk by observing, "The most common pitfall I've seen regarding effective CAPA systems is underestimating the complexity of the project. It is more than just a root cause issue; it is a complete process which requires copious amounts of time and resources managed by a capable team with experience, decision making skills, and support at the highest levels in order to manage the organizational change needed to result in an enhanced and sustained quality environment." She presented dozens of best practice tips together with several illustrative case studies during her talk.
Reese underscored the importance of giving CAPA a high corporate priority when she said, "developing a proactive CAPA culture is ideal because correcting and preventing issues early on diminish risk exposure for the company and cost significantly less than fixing them later on." According to Reese, "The ideal CAPA systems do not disrupt the overall process nor expose the company to unnecessary or avoidable risk."
Now in its thirtieth year, Maetrics is a leading global consulting firm specializing in compliance strategy and solutions:
- regulatory and compliance
- performance improvement
- risk management
- organizational change management
- information technology
for top-tier medical device, pharmaceutical, and biotech companies. Maetrics' headquarters is in Indianapolis, Indiana, USA, and it supports its global client base through offices worldwide.
8888 Keystone Crossing
Indianapolis, IN 46240 USA
Phone: +1 877-623-8742
For more information, photography, or to
schedule an interview, please contact:
Samantha Bucher +1 215-627-3030
Aug. 31, 2015 11:00 PM EDT Reads: 498
Aug. 31, 2015 10:30 PM EDT Reads: 395
Aug. 31, 2015 09:00 PM EDT Reads: 363
Aug. 31, 2015 07:15 PM EDT Reads: 479
Aug. 31, 2015 07:00 PM EDT
Aug. 31, 2015 06:30 PM EDT Reads: 521
Aug. 31, 2015 06:00 PM EDT Reads: 243
Aug. 31, 2015 04:45 PM EDT
Aug. 31, 2015 04:30 PM EDT Reads: 455
Aug. 31, 2015 04:30 PM EDT
Aug. 31, 2015 03:15 PM EDT
Aug. 31, 2015 03:00 PM EDT Reads: 248
Aug. 31, 2015 02:45 PM EDT Reads: 375
Aug. 31, 2015 02:30 PM EDT Reads: 456
The Internet of Things (IoT) is about the digitization of physical assets including sensors, devices, machines, gateways, and the network. It creates possibilities for significant value creation and new revenue generating business models via data democratization and ubiquitous analytics across IoT networks. The explosion of data in all forms in IoT requires a more robust and broader lens in order to enable smarter timely actions and better outcomes. Business operations become the key driver of I...
Aug. 31, 2015 02:30 PM EDT Reads: 417