Tampa, FL —January 9, 2017 — Pilgrim Quality Solutions, a leading global provider of enterprise quality management software and services for the Life Sciences, today announced that Kari Miller, Pilgrim’s Vice President of Regulatory & Product Management, and Konyika Nealy, Vice President of QA & Validation, will address attendees at the 5th Annual Medical Device Safety Monitoring and Reporting conference, being held January 25-26, 2017, in Las Vegas.
The annual conference focuses its content on approaches to fortifying post-market surveillance to expedite complaint handling and reinforce patient and product safety. This year, Medical Device industry insiders will convene to learn ways to bolster their quality management systems so they can elevate their global monitoring and reporting activities and achieve international regulatory compliance.
Ms. Miller will deliver a presentation on Leveraging Structured Quality Management System (QMS) Data to Achieve Global “Data Driven” Compliance with Increased Regulatory Harmonization. She will address various methods of exploiting regulatory updates to initiate and later fortify enterprise-wide QMS transformation, and to improve worldwide compliance within a medical device organization.
“The need for organizations to adopt a global enterprise philosophy for QMS is more important than ever,” Ms. Miller said. “Regulators around the world are working together to harmonize regulatory requirements in a manner that will ensure the safety and efficacy of medical devices and establish sustainability. This global regulatory cooperation and visibility dictates QMS evolve to incorporate all stakeholders in the extended value chain, including regulators, to not only maintain but improve quality and compliance.”
Ms. Miller’s presentation will follow a case study on Internal Data Management systems by Michele Donatich, R.N., Director of Product Quality and Regulatory Compliance for Cardinal Health. The case study will describe ways to connect interdepartmental data management systems to amplify track and trend abilities, and to centralize those systems to consolidate reporting mechanisms and expedite investigations. Cardinal Health supports these processes with Pilgrim’s integrated QMS platform.
“Industry standards and regulatory guidelines recommend quality management processes which are integrated across the entire value chain,” said Richard Lowrey, Chief Executive Officer for Pilgrim Quality Solutions. “Pilgrim’s enterprise platform solutions allow our customers to gain insight over their quality management operations with built-in capabilities for monitoring and managing key processes, including the ability to monitor and report on product safety and support global compliance.”
Pilgrim’s Ms. Nealy will join the conference agenda in an interactive panel discussion with experts from Baxter Healthcare, Edwards Lifesciences and Roche Diagnostics. This elite panel will address approaches to Devising a Proactive Audit Readiness Plan in Anticipation of Future Local and Global Audits.
“Audit readiness requires strategic use of all the resources at your disposal,” Ms. Nealy said. “FDA warning letters, internal audits, mock inspections, and audit management tools play an important role in preparing for and managing a regulatory audit. I am thrilled to join this panel of experts. This type of information sharing among peers who have first-hand, practical experience with FDA inspections is invaluable to help each other prepare for success.”
In addition to Ms. Miller’s and Ms. Nealy’s educational sessions, Pilgrim Quality Solutions will host an exhibit at the conference to share information about its leading enterprise-wide quality management solutions. Pilgrim provides best-practice quality and compliance management solutions on a configurable and validated integrated platform to meet industry quality and regulatory standards such as ISO, GXP, and FDAs 21 CFR mandates, making it easier for medical device, pharmaceutical and other Life Sciences companies to manage operational quality, reduce their Cost of Quality, achieve regulatory compliance, and mitigate risk. Pilgrim Quality Solutions was recently named 2016 Frost & Sullivan Value Leadership winner for Medical Device Customers.
About Pilgrim Quality SolutionsPilgrim Quality Solutions is the leader in quality compliance management software and services for Life Sciences. For more than 20 years, our solutions have automated thousands of processes across global company sites to manage the quality and compliance of life’s most important products. Our cloud-based and on-premise solutions include in-the-box best practice workflows, document and process management, dashboards, electronic signatures, audit trails, and automated validation – helping companies more easily achieve quality system compliance and pass regulatory audits. Pilgrim Quality Solutions is majority owned by Boston-based private equity firm, Riverside Partners LLC. With Pilgrim Quality Solutions as your partner, you are prepared to succeed. For more information, visit www.pilgrimquality.com.