TAMPA, Fla.--(BUSINESS WIRE)--Pilgrim Quality Solutions, a leading global provider of enterprise quality management software and services for the Life Sciences, today announced the upcoming webinar, “The World of Quality Metrics – Yesterday, Today, and Tomorrow,” a 60-minute webcast addressing the role of quality metrics within the regulatory industry, and the initiatives launched by the medical device and pharmaceutical industries to integrate quality data into their manufacturing systems.
Pilgrim, in tandem with the Florida chapter of the Regulatory Affairs Professional Society (RAPS), is co-sponsoring the presentation from Marla Phillips, Ph.D., Director of Xavier Health at Xavier University. Ms. Phillips will examine the current efforts of both the Center for Diseases and Radiological Health (CDER) and the Center for Drug Evaluation and Research (CDER) to extend their industry’s and the Food and Drug Administration’s (FDA) focus beyond compliance and toward a higher assurance of quality.
In 2011, CDRH launched “The Case for Quality” initiative to begin this shift in focus, Phillips explains. In 2012, the FDA Safety and Innovation Act (FDASIA) was passed by Congress. “Since that time, industry has seen CDRH and CDER move in different directions and at a different pace toward end goals that seem similar, but yet unclear.”
Ms. Phillips co-led, with the FDA, the CDRH metrics initiative, and co-led with PricewaterhouseCoopers, the pharmaceutical metrics initiative. Her presentation will examine the difference between the two initiatives, their progress, the differences and similarities in their metrics, and where both initiatives are headed.
The webinar will include additional insights from Kari Miller, Pilgrim’s Regulatory & Product Management Leader, on the ways in which both the CDRH and CDER programs affect quality management systems. Ms. Miller will examine how medical device and pharmaceutical manufacturers can structure data within those systems, and how to effectively report against it.
“For most businesses, building a global quality system involves changes to processes, systems, and culture,” Ms. Miller said. “The inclusion of structured quality data is one of the significant factors that will allow Life Sciences manufacturers to make their case for Quality System Transformation across their enterprise.”
“The World of Quality Metrics – Yesterday, Today, and Tomorrow” will be broadcast live on Thursday, April 27, at 12:00 p.m. (EDT). Visit http://www.raps.org/events/ or www.pilgrimquality.com/about-pilgrim/events to register.
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with offices in Shanghai and Singapore and chapters and affiliates worldwide. www.raps.org
About Pilgrim Quality Solutions
Pilgrim 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.