2021 PDA Data Integrity Workshop
Registration Options
Individual Registration
Group Registration
Data Integrity continues to be a major concern for Health Authorities and the pharmaceutical industry. Even though data integrity is a foundational requirement of all GXP regulations, there continues to be an increased focus on this topic both from a regulatory and industry perspective as data integrity breaches drive a significant number of Health Authority enforcement actions such as Warning Letters, Import Alerts, product quarantines, and suspension or revocation of Marketing Authorizations. Moreover, additional guidelines and regulations have been published to establish Data Integrity Standards.
Exciting new opportunities for people, process, products, and technologies emerge through the introduction of Data Governance, Data Process Design, Data Analytics, and Big Data initiatives—all with an intent to optimize the availability, usability, and reliability of data to enhance Management Review and Knowledge Management Programs. But meaningful Data Governance and a ‘Data Quality Culture’ cannot be achieved solely by Information Technology or the Quality Unit. Instead, Business Process Owners (i.e., “Data Owners”)--who understand the intended use(s) of their data and potential risks to patients, products, and application integrity--must play a primary role in data process improvements and data integrity risk reductions. This collaborative journey requires Management Commitment and modern, agile, flexible, and scalable Quality Risk Management strategies and inspired Cultural Change Management.
This conference will be comprised of interactive case studies, presentations, and panel discussions. Come join us to share experiences, learnings, and ideas.
At the completion of this event, attendees will be able to:
- Understand roles and responsibilities for Data Owners in management of data and knowledge across product life cycle
- Understand the current regulatory climate and remediation expectations and to define what is needed to engrain Data Integrity into the Quality Management System and Culture.
- Discuss proactive approaches for Data Owners in optimizing computerized systems and data process governance
- Promote a holistic understanding of the challenges faced by the industry in detecting and remediating data integrity risks
- Discuss strategies on how to utilize Quality Risk Management to prevent Data Integrity issues and establish a quality culture which promotes Data Integrity as a core value.
Contact
Program Inquiries
Training Course Inquiries
Registration Customer Care
Standard Registration
Member Price
$837GovernmentMember Only
$392
Health AuthorityMember Only
$392
StudentMember Only
$157
AcademicMember Only
$392
Non-Member
$1,033
Day 1
Wednesday, 22 September
09:45 – 11:30 EDT | P1: Data Ownership Across the Product Life Cycle |
09:45 – 09:50 EDT | Welcome and Overview from Workshop Chair 09:50 – 10:20 EDT | Data Governance: Exploiting the value of Metadata using Data Analytics 10:20 – 11:05 EDT | Data Owner’s Manual: Applications are Not ‘One and Done’ 11:05 – 11:30 EDT | Q&A |
11:30 – 11:45 EDT | Break
11:45 – 13:15 EDT | P2: Applying Data Integrity to Realize Data as an Asset |
11:45 – 12:15 EDT | Fit for Purpose: Enabling Optimized Data Usage through a Modern Validation Approach 12:15 – 12:45 EDT | Small Systems with Critical Data Assets: Innovation for Data Integrity and Usability 12:45 – 13:15 EDT | Q&A 13:15 – 13:30 EDT | Day 1 Closing Remarks |
Day 2
Thursday, 23 September
09:45 – 11:30 EDT | P3: Data Quality Culture |
09:45 – 09:50 EDT | Day 1 Recap Monica J. Cahilly, MS, President/Consultant, Green Mountain Quality Assurance 09:50 – 10:25 EDT | The Brain Behind the Curtain: Unlocking the Data Quality Culture 10:25 – 11:00 EDT | The Human Factors of Expert Decision Makers 11:00 – 11:30 EDT | Q&A |
11:30 – 11:45 EDT | Break
11:45 – 13:30 EDT | P4: Current Regulatory and Compliance Perspectives on Data Integrity in Changing Times |
11:45 – 12:45 EDT | Brooke K. Higgins, MS, Senior Policy Advisor, CDER, U.S. FDA 12:45 – 13:15 EDT | Q&A Panel 13:15 – 13:30 EDT | Closing Remarks from Workshop Chair |
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.