Reducing Human Error in the Operating Room

One of the best tools for achieving better communication in the clinical setting is Crew Resource Management (CRM). CRM increases patient safety and operational efficiency by empowering all team members to identify and communicate potential patient har…

Building and Sustaining a Blood Management Program

Implementing a standardized blood management program is one hospital initiative that addresses many of today’s challenges, including reduced funds, rising blood costs, and the desire for better clinical outcomes. Blood transfusions are one of the most …

How Effective Training Management Can Help You Prevent Quality Issues

It’s not enough to have your quality standards on paper. You have to implement and integrate them into your daily operations and prove to regulators that your standards and policies work. “Effective training should be a fundamental part of a company’s quality management strategy as it can help prevent many quality problems from ever occurring,” said Hunter.

In a regulated environment, training is a means to minimize (if not avoid) human error, a common cause of deviations and nonconformances. It’s no wonder that various standards and regulations, such as the following, require training as an integral part of the quality management system.

  • FDA 21 CFR Part 211.25 for pharmaceutical companies
  • FDA 21 CFR Part 820.25 for medical device manufacturers
  • ISO 9000 2000 for general manufacturers and other businesses
  • ISO 13485 for medical device manufacturers

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How to Address the Top 6 Pains in DHF Management

If your DHF is paper-based or hybrid (part electronic and part paper-based), the challenges grow exponentially. Discover insights that might help you address your DHF challenges. As well as the top 6 pains and recommendations for addressing them:

  1. The Organization is Unprepared for Audits
  2. The Design Review Process is Bumpy
  3. It’s Almost Impossible to Get the Signatures of Top Executives
  4. It’s Difficult to Implement Postmarket Change Control or CAPA
  5. Finding Documents through a “Gatekeeper” is Inefficient
  6. Managing DHF and Technical Dossier Can Require Two Teams

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How to Address the Top 6 Pains in DHF Management

If your DHF is paper-based or hybrid (part electronic and part paper-based), the challenges grow exponentially. Discover insights that might help you address your DHF challenges. As well as the top 6 pains and recommendations for addressing them:

  1. The Organization is Unprepared for Audits
  2. The Design Review Process is Bumpy
  3. It’s Almost Impossible to Get the Signatures of Top Executives
  4. It’s Difficult to Implement Postmarket Change Control or CAPA
  5. Finding Documents through a “Gatekeeper” is Inefficient
  6. Managing DHF and Technical Dossier Can Require Two Teams

Request Free!

State of Cybersecurity in Health Care Organizations

Health Care is often considered a lucrative business for those involved in waste, fraud and abuse. Today’s ever-accelerating technology changes make data related to health care, medical and financial issues even more attractive to cybercriminals who se…