FDAnews Announces — New Management Report — CDRH in Transition: Navigating the New Culture of Quality

Share Article

CDRH in Transition: Navigating the New Culture of Quality outlines the Culture of Quality program’s goals and explains how they will change the way devicemakers will experience inspections.

CDRH in Transition: Navigating the New Culture of Quality outlines the Culture of Quality program’s goals and explains how they will change the way devicemakers will experience inspections.

“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.

CDRH in Transition: Navigating the New Culture of Quality outlines the Culture of Quality program’s goals and explains how they will change the way devicemakers will experience inspections. Readers will 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, the team of investigators will include at least one specialist in a product area, making it harder to hide faults. Don’t let the CDRH’s paradigm shift rock the world.

Who Will Benefit:

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

FDAnews Management Report Details:
CDRH in Transition:
Navigating the New Culture of Quality
Price: $397
http://www.fdanews.com/products/54893-cdrh-in-transition    

Easy Ways to Order:
Online:     http://www.fdanews.com/products/54893-cdrh-in-transition            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

CDRH in Transition:
Navigating the New Culture of Quality
**An FDAnews Management Report**
http://www.fdanews.com/products/54893-cdrh-in-transition

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Michelle Butler
FDANEWS
+1 (703) 538-7665
Email >
FDAnews
Like >
Visit website