Welcome!

News Feed Item

Best Practices For Corrective And Preventive Actions (CAPA) Presented By Distinguished Quality And Compliance Executive At Medical Device And Pharmaceutical Leadership Roundtable

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.

Debara Reese, Vice President Quality and Compliance for Maetrics, a leading global life sciences compliance consulting firm, recently discussed best practices and common CAPA pitfalls at the exclusive, second annual Sustaining Effective CAPA Systems Conference in San Diego.

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.

Maetrics
8888 Keystone Crossing
Suite 1550
Indianapolis, IN 46240 USA
Phone: +1 877-623-8742
www.maetrics.com

For more information, photography, or to
schedule an interview, please contact:
Samantha Bucher +1 215-627-3030
[email protected]

Photo - http://photos.prnewswire.com/prnh/20140730/131009

SOURCE Maetrics

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
The need for greater agility and scalability necessitated the digital transformation in the form of following equation: monolithic to microservices to serverless architecture (FaaS). To keep up with the cut-throat competition, the organisations need to update their technology stack to make software development their differentiating factor. Thus microservices architecture emerged as a potential method to provide development teams with greater flexibility and other advantages, such as the abili...
ChatOps is an emerging topic that has led to the wide availability of integrations between group chat and various other tools/platforms. Currently, HipChat is an extremely powerful collaboration platform due to the various ChatOps integrations that are available. However, DevOps automation can involve orchestration and complex workflows. In his session at @DevOpsSummit at 20th Cloud Expo, Himanshu Chhetri, CTO at Addteq, will cover practical examples and use cases such as self-provisioning infra...
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life settle...
Product connectivity goes hand and hand these days with increased use of personal data. New IoT devices are becoming more personalized than ever before. In his session at 22nd Cloud Expo | DXWorld Expo, Nicolas Fierro, CEO of MIMIR Blockchain Solutions, will discuss how in order to protect your data and privacy, IoT applications need to embrace Blockchain technology for a new level of product security never before seen - or needed.
Leading companies, from the Global Fortune 500 to the smallest companies, are adopting hybrid cloud as the path to business advantage. Hybrid cloud depends on cloud services and on-premises infrastructure working in unison. Successful implementations require new levels of data mobility, enabled by an automated and seamless flow across on-premises and cloud resources. In his general session at 21st Cloud Expo, Greg Tevis, an IBM Storage Software Technical Strategist and Customer Solution Architec...
The cloud era has reached the stage where it is no longer a question of whether a company should migrate, but when. Enterprises have embraced the outsourcing of where their various applications are stored and who manages them, saving significant investment along the way. Plus, the cloud has become a defining competitive edge. Companies that fail to successfully adapt risk failure. The media, of course, continues to extol the virtues of the cloud, including how easy it is to get there. Migrating...
The use of containers by developers -- and now increasingly IT operators -- has grown from infatuation to deep and abiding love. But as with any long-term affair, the honeymoon soon leads to needing to live well together ... and maybe even getting some relationship help along the way. And so it goes with container orchestration and automation solutions, which are rapidly emerging as the means to maintain the bliss between rapid container adoption and broad container use among multiple cloud host...
Blockchain is a shared, secure record of exchange that establishes trust, accountability and transparency across business networks. Supported by the Linux Foundation's open source, open-standards based Hyperledger Project, Blockchain has the potential to improve regulatory compliance, reduce cost as well as advance trade. Are you curious about how Blockchain is built for business? In her session at 21st Cloud Expo, René Bostic, Technical VP of the IBM Cloud Unit in North America, discussed the b...
Blockchain. A day doesn’t seem to go by without seeing articles and discussions about the technology. According to PwC executive Seamus Cushley, approximately $1.4B has been invested in blockchain just last year. In Gartner’s recent hype cycle for emerging technologies, blockchain is approaching the peak. It is considered by Gartner as one of the ‘Key platform-enabling technologies to track.’ While there is a lot of ‘hype vs reality’ discussions going on, there is no arguing that blockchain is b...
Imagine if you will, a retail floor so densely packed with sensors that they can pick up the movements of insects scurrying across a store aisle. Or a component of a piece of factory equipment so well-instrumented that its digital twin provides resolution down to the micrometer.
"IBM is really all in on blockchain. We take a look at sort of the history of blockchain ledger technologies. It started out with bitcoin, Ethereum, and IBM evaluated these particular blockchain technologies and found they were anonymous and permissionless and that many companies were looking for permissioned blockchain," stated René Bostic, Technical VP of the IBM Cloud Unit in North America, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Conventi...
As DevOps methodologies expand their reach across the enterprise, organizations face the daunting challenge of adapting related cloud strategies to ensure optimal alignment, from managing complexity to ensuring proper governance. How can culture, automation, legacy apps and even budget be reexamined to enable this ongoing shift within the modern software factory? In her Day 2 Keynote at @DevOpsSummit at 21st Cloud Expo, Aruna Ravichandran, VP, DevOps Solutions Marketing, CA Technologies, was jo...
While some developers care passionately about how data centers and clouds are architected, for most, it is only the end result that matters. To the majority of companies, technology exists to solve a business problem, and only delivers value when it is solving that problem. 2017 brings the mainstream adoption of containers for production workloads. In his session at 21st Cloud Expo, Ben McCormack, VP of Operations at Evernote, discussed how data centers of the future will be managed, how the p...
"Since we launched LinuxONE we learned a lot from our customers. More than anything what they responded to were some very unique security capabilities that we have," explained Mark Figley, Director of LinuxONE Offerings at IBM, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
When shopping for a new data processing platform for IoT solutions, many development teams want to be able to test-drive options before making a choice. Yet when evaluating an IoT solution, it’s simply not feasible to do so at scale with physical devices. Building a sensor simulator is the next best choice; however, generating a realistic simulation at very high TPS with ease of configurability is a formidable challenge. When dealing with multiple application or transport protocols, you would be...