RQM+ subject matter experts share case studies, lessons learned, and best practices.

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RQM+ Live! is an interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device and diagnostics industries. The panelists also answer your questions live! Every episode is added to our podcast, too.

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RQM+_Live_38_RecordedMarket consolidation and acquisitions along with the relocation of design centers and manufacturing facilities to OUS locations are resulting in what appears to be a continuous cycle of site transfers for medical device companies. RQM+ is a strategic partner to these companies, providing all things regulatory and quality associated with the transfers. Our subject matter experts have case studies, lessons learned and best practices across activities in regulatory registrations, quality systems, process validations, project management, and remediation. In this show we'll discuss solutions to some of the biggest gaps and challenges we encounter, including

  • Mass quantities of labeling revisions
  • Quality Plan to bridge the gaps: quality management systems, site and product registrations, process validation, calibration, equipment maintenance
  • Process validation in a different country and unexpected challenges
  • Project management that ensures QA/RA activities are appropriately prioritized
  • Staffing
  • And more!
Join our discussion and bring your questions for our subject matter experts! They'll be ready and excited to answer.

The panel will include:

  • Ralph Asencio - Vice President of Technical Services

  • Nancy Morrison, RAC - Executive Director, Regulatory and Quality Consulting Services

  • Catherine Kang - Senior Engineer

 

"With partners like you I feel even more confident. I’m very appreciative of how you are presenting both short and long term solutions and speaking your ‘regulatory philosophy’ out loud."

Director, Clinical Compliance, Multinational Medical Device Manufacturer