September 13, 2019

RAPS Regulatory Convergence Conference 2019Next week, AssurX will be exhibiting at the annual Regulatory Affairs Professionals Society (RAPS) Convergence Conference 2019 in Philadelphia.  RAPS is the largest global organization for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics, and nutritional products. 

The event brings thought leaders and solution providers together for three days of unprecedented knowledge sharing and insights including:

  • New and innovative approaches to examine and solve regulatory challenges 
  • Opportunities for life science regulatory professionals to get familiar with the latest regulatory news as well as share experiences with their peers.  
  • Regulatory compliance solutions that improve the way quality and regulatory information is analyzed, processed, and presented.  

The RAPS Regulatory Convergence Conference 2019: Navigating the Regulatory Gray will take place at the Pennsylvania Convention Center, in Philadelphia, PA, from September 22-24, 2019.  

The AssurX team will be available to demonstrate how the AssurX Quality Management and Regulatory Compliance System helps medical device, pharmaceutical, and biotech manufacturing companies navigate gray areas of compliance practices through process automation.

Meet the AssurX team in Booth 210 and get expert advice on modernizing regulatory processes with a system that intuitively guides documentation, submissions and knowledge transfer based on industry best practices.  Join us for minisessions highlighting the following:

Compliance Advantages of a Centralized Document Management System

Learn how to structure and manage controlled documents such as standardsprocedures, and design files that include specificationstrace matrices, and protocols. Discuss solutions to support collaborative review as well as editing, electronic signatures, and managed access.
Sunday, Sept. 22 6:15 p.m. Tuesday, Sept. 24 11:45 a.m.

Spotlight on Training Management

Discover the simplicity of managing training compliance and reinforcing a culture of compliance through seamless execution and documentation of required training.
Monday, Sept. 23 9:30 a.m.Tuesday, Sept.  12:45 p.m. 

Postmarket Surveillance and Vigilance

Gain insights into digitizing post-market surveillance and vigilance to meet the expectations of medical device reporting (MDR) requirements through the EU Medical Incident Report (MIR) and FDA MedWatch 3500A forms.
Sunday, Sept. 22 7:00 p.m. Monday, Sept. 23  3:30 p.m. 

Attend one of our 10 minutes sessions or stop by anytime with your questions on how your organization can implement an electronic quality management and regulatory compliance system that features configurable workflows, flexible scaling, and integration with other enterprise systems