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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/FDA Joint Regulatory Conference

Breakfast 8: Quality Culture
Moderator: Susan Schniepp, Fellow, Regulatory Compliance Associates Inc.

PDA has recognized the importance culture has on an organization since the first quality metrics meeting in 2014. The ability of an organization to manufacture products in a compliant manner depends on people's behavior and management's guidance. PDA quality culture/quality metrics task force has developed a quality culture assessment tool that maps quality behaviors to quality attributes. Members of the task force will be presenting one of the training modules from this tool so attendees can understand this relationship and how it can impact the overall company performance.

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PDA Risk Management in the Regulatory Landscape Conference

Dec 09 - Dec 10, 2019 / Washington, DC

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PDA Building a Foundation and Culture for Quality Risk Management Integration Workshop

Dec 11, 2019 / Washington, DC

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PDA Optimizing Quality Risk Management Conference

Dec 12 - Dec 13, 2019 / Washington, DC

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