July 23, 2021

Live! #38 — Best Practices in Site Transfer (or Consolidation)

40 minutes

This is the audio-only version of RQM+ Live! #38, originally recorded 22 July, 2021.

Market 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

About RQM+

RQM+ is the world's leading (and largest) medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.

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