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PDA Quality Culture

PDA 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.

 
 

Publications

Root Cause Analysis Reference Guide

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

The Role of Quality Culture on Operational Performance

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

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

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

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

Quality Culture vs. Cost of Quality

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

 
 
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Training Courses

PDA’s Quality Culture Transformation Program gives companies access to four tools to measure and ultimately improve their commitment to quality.

Companies begin with training in a PDA-run course. Next, they receive PDA’s Assessment Tool to conduct a site self-assessment. Then, they will complete PDA’s quality culture survey. The program concludes with a benchmarking report that analyzes where the company/site stands vis a vis other companies completing the program.

The PDA Quality Culture Transformation Program was developed in a pilot program in 2016-2017 that resulted in more than 60 trained assessors and benchmarking data from over 9000 survey respondents. As of today, more than 50 companies at more than 25 sites have completed the program.

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Other PDA Quality Culture training programs

Measuring Quality Culture Maturity? Learn how!

Oct 24 - Oct 25, 2019 / Gothenburg, Sweden

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Quality Culture: Why Assessment is Important

Sept 23 - Dec 31, 2019 / Online

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Conferences

PDA Annual Meeting

Metrics and Mature Quality Systems
Moderator: Steve Mendivil

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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