Quality Culture

PDA Resources for Developing a Mature Quality Culture

A strong quality culture is critical to an organization and has a significant influence on the overall quality of the product, especially for those organizations relying on quality metrics to monitor and drive continuous improvement. Harvard Business Review defines “true culture of quality” as an environment in which employees not only follow quality guidelines but also consistently see others taking quality‐focused actions, hear others talking about quality, and feel quality all around them. Developing a mature quality culture and measuring progress across the supply chain can be challenging. PDA’s Quality Culture initiative is designed to help pharmaceutical quality personnel guide their organizations toward a mature quality culture.


Root Cause Analysis Reference Guide

This document describes a range of RCA tools that can be applied in the search for “true root cause.”

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The Role of Quality Culture on Operational Performance

Article by staff of the University of St Gallen and PDA Volunteers

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U.S., UK Regulators Share Passion for Quality Culture

Quality culture has often been characterized as the driver behind effective quality systems...

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PDA comments

PDA is working to shape FDA's perspective on Quality Metrics.

Survey Report

PDA's global survey of quality culture in the pharmaceutical industry

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Quality Culture vs. Cost of Quality

Quality Culture is understanding the value, not just the price, of quality.

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Training Courses

Take the first steps toward evaluating the quality culture at your site and identifying opportunities for improvement by enrolling in PDA's Quality Culture Assessment Tool training course.

This training course will teach you how to use PDA's Quality Culture Assessment Tool to effectively collect verifiable data and feedback. As a result, the tool will allow you to facilitate positive culture changes and continuous improvement within your organization.

At the end of this training, you will be provided with the following resources to begin assessing your company’s quality culture:

  • PDA Quality Culture Assessment Tool
  • Matrix and Example Interview Questions
  • Site Kick Off/Leadership Presentation
  • Pre-Audit Questionnaire
  • Quality Culture Survey

Check out our current offerings for this training course along with our other training courses on quality culture below, or click the button below for more information about PDA's Quality Culture Assessment Tool.

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PDA Annual Meeting

The Center for Drug Evaluation and Research (CDER) is exploring quality system maturity as an alternative approach to addressing drug shortages and compliance risk. Recently, Dr. Janet Woodcock, CDER Director, has written in support of FDA’s Drug Shortage Task Force’s recommendation of a voluntary rating system of a sites “quality management maturity” that firms could share with potential purchasers to allow quality of supply to be a factor in the purchase of pharmaceuticals. Dr. Woodcock supports introducing transparency of sites ability to sell “quality” to purchasers and patients to enable firms to compete for quality and reliability of the drug supply and not just the lowest cost. Drug shortages has tremendous costs for both the health care industry but also for patients. This rating system would allow purchasers to pay for a more reliable and stable drug supply. PDA, PhRMA, St. Gallen, and other organization have been working on maturity models that help identify mature quality systems and strong quality culture organizations that could be used by industry and FDA’s New Inspection Protocol Project (NIPP). This session will provide an overview of various efforts working on maturity models and FDA’s current plans to adopt and utilize them.

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