Fremont, CA: August 04, 2016NetZealous LLC, a professional trainings provider in the areas of regulatory compliance, human resources, healthcare and IT, offers trainings for medical device professionals to help build a sound Corrective and Preventive Action (CAPA) for their quality systems by making a thorough root cause analysis.
The importance of the CAPA cannot be understated. Getting it right is essential for medical device companies’ quality systems. The fundament of a CAPA is the root cause analysis, on which the CAPA is built. The importance of a root cause analysis can be understood from the fact that a faulty root cause analysis not only impedes the development of a CAPA; it makes corrections into the later stages impossible.
As a result, quality and compliance issues take center stage, leading to failure of the product. It is no wonder that despite its criticality to the Quality System of a medical device; CAPA is the most cited reason for punitive actions from the FDA, such as 483’s and Warning Letters.
A means to help avoid failures
“The root cause analysis is at the root, literally and figuratively, of the quality systems. Medical device companies that get this wrong are certain to get their CAPA wrong, which in turn finally leads to a defective product. Getting the root cause analysis wrong is like building a fortress on a weak foundation. Our trainings are aimed at helping professionals in the medical devices industry develop a sound root cause analysis, which will lead them to satisfactory outcomes that lead to regulatory compliance. Our experts have been around in the industry for many decades, and this experience helps them aid medical device professionals in building a solid CAPA, which is the basis to the development of reliable and valid quality systems”, said Satisha Naraharimurthy, Founder and CEO of NetZealous LLC.
Helping medical device companies get their CAPA right
Resolution of quality issues is the chief aim of NetZealous LLC’s professional trainings, said Shahanshah Manzoor, Co-Founder and Chief Marketing Officer at NetZealous LLC. “The aim of our trainings is to help participants in the medical device industry understand the ways of getting their CAPA right. Our experts come from very rich backgrounds in the area of medical devices and their quality systems. Through these trainings, they get insights into all aspects of the quality systems, such as building the right team, developing a problem statement which underlines the current problem the Quality System is facing, the tools and techniques required for analysis, ways of verifying the results, what to do an what not to, case studies, and many others. We believe in offering comprehensive solutions to a CAPA”, he said.
Liju Mathew, Co-Founder and Chief Business Development Officer at NetZealous LLC says that these trainings from NetZealous LLC are useful for a host of professionals across the medical devices industry. Anyone involved in any aspect of the Quality Systems, such as Quality, Manufacturing, Design, Supplier, or Process Engineers, Compliance Specialists, Auditors, Compliance Managers, CAPA Specialists or Managers, Regulatory Affairs Managers, and CAPA Project Managers derive a lot of benefit from these trainings. The aim of these trainings is to help these professionals achieve their best possible result for their CAPA, so that the enormous resources they spend on these activities don’t get wasted, he says.