CDRH in Transition: Navigating the New Culture of Quality

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CDRH in Transition
Navigating the New Culture of Quality

CDRH’s program alignment went into effect in May 2017, changing the center’s inspection practices and creating a new Culture of Quality and Organizational Excellence that focuses attention on product quality rather regulatory compliance.

“A Regulatory Paradigm Shift” is how Cisco Vicenty — Program Manager for CDRH’s Culture of Quality and Organizational Excellence initiative — describes the center’s new focus on manufacturing quality over compliance.

In CDRH in Transition: Navigating the New Culture of Quality he explains why compliance and quality don’t necessarily go hand-in-hand and how the center’s GMP inspections program intends to increasingly emphasize what a company is doing right over dinging them for what they’ve done wrong.

Vicenty outlines the Culture of Quality program’s goals and explains how they will change the way devicemakers will experience inspections. You’ll learn about:

  • The goals of the Case for Quality program and CDRH’s inspection emphasis

  • Framework and implementation plans for CDRH’s new Voluntary Quality Program Pilot, which will test the concept of evaluating devicemakers’ excellence rather than compliance

  • Plans for metrics-based evaluations and what data devicemakers will be required to submit, such as product quality complaint rate and lot acceptance rate

  • Inspection statistics from FY 2016, including the main 483 observations, and how to learn from them

  • The eight program realignment commitments CDRH has made, including increasing investigator specialization and improving enforcement strategies

Under the new inspection system, your team of investigators will include at least one specialist in your product area, making it harder to hide your faults. Don’t let the CDRH’s paradigm shift rock your world.

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Table of Contents

  • Introduction
  • Change in Focus for CDRH Compliance Efforts
  • CDRH’s Voluntary Quality Program Pilot
  • FDA Enforcement Trends
  • And More …

View the entire TOC

Who Will Benefit

  • Quality managers
  • Executive level
  • Business operations
  • Regulatory affairs
  • Legal

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