2021 PDA Data Integrity Workshop

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.