The Future of Quality
Division: All - Regulatory/Standards
Regulatory authorities around the globe focus on data integrity during their inspections of pharmaceutical and medical device companies. Many other industries also find value in incorporating data integrity concepts in their organizations. Quality auditors can help their organizations reduce risk by ensuring that data integrity issues are identified, risks are mitigated, and product or service quality is protected. This session will address: data integrity concepts and principles; regulatory requirements related to data integrity; specific areas where regulatory authorities focus their inspections; and key areas for auditors to assess for electronic and paper records.
Attend this session to understand the current expectations for data integrity as well as techniques and tools for conducting effective data integrity audits. Attendees will participate in interactive exercises to learn how to identify data integrity issues during an audit.