PDA 538.1 Quality Culture Assessment

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The U.S. FDA continues to focus on the use of quality metrics to modernize pharmaceutical quality systems and advance innovation. In a published document, FDA has called for routine assessment and management oversight of quality culture.

Make sure your company stays ahead of the curve! Prepare for this reporting on quality culture with PDA's comprehensive Quality Culture Assessment Tool, designed to guide your company to a better understanding of quality culture, how to assess it, and what actions to take to improve it.

In this live eLearning training course, you will learn how to use this tool to effectively collect verifiable data. As a result, the tool will allow you facilitate positive culture changes and continuous improvement within your organization.

The goal is to ensure that a quality mindset and behaviors are embedded into the daily work of the individuals involved in all functions to ultimately ensure the delivery of high-quality product to patients.

At the end of this training, you will be provided with the following tools 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
For more options and/or related training courses, please visit the page(s) below.

PDA Quality and Compliance Training Courses

  1. Have an aligned understanding of the Quality Culture Assessment Program
  2. Perform their role as an assessor to properly conduct the assessment process
  3. Score and report assessment results
  4. Prepare for a successful site assessment

Standard Registration

Member Price


GovernmentMember Only


Health AuthorityMember Only


Early Career ProfessionalMember Only


StudentMember Only


AcademicMember Only




See Qualifying Criteria for Member Types.

Day 1

Welcome and Introductions (10 min)

The Quality System / Quality Policy / Regulatory Expectations (50 min)

Quality Metrics Influence on Quality Culture (40 min)

Break (15 min)

Mock Assessment (60 min)

Performing the Assessment at Your Company (20 min)

Q&A (15 min)

Agenda is subject to change.

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