PDA 538.1 Quality Culture Assessment
Registration Options
Individual Registration
Group Registration
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
- Have an aligned understanding of the Quality Culture Assessment Program
- Perform their role as an assessor to properly conduct the assessment process
- Score and report assessment results
- Prepare for a successful site assessment
Contact
Program Inquiries
Training Course Inquiries
Registration Customer Care
Standard Registration
Member Price
$999GovernmentMember Only
$999
Health AuthorityMember Only
$999
Early Career ProfessionalMember Only
$999
StudentMember Only
$999
AcademicMember Only
$999
Non-Member
$999
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)
Become a Sponsor
Interested in becoming a sponsor? Learn about opportunities and benefits.
Request InformationBecome an Exhibitor
Interested in becoming an exhibitor? Learn about opportunities and benefits.
Request InformationPLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.