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Pilgrim Presents “The World of Quality Metrics” – A Live Webinar for the Medical Device & Pharmaceutical Industries

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by April 24, 2017 General

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.

About RAPS

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.

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