Data Integrity Workshop, 517 June, Marriott Crystal Gateway, Arlington, VA

Data Integrity Education

The half-day Data Integrity workshop will be a combination of general sessions and breakout sessions, facilitated by data integrity experts providing participants an opportunity to apply their acquired data integrity knowledge to realistic scenarios. Attendees will have the opportunity to interact with regulatory and pharmaceutical industry experts in a small group setting to identify data integrity gaps and risks facing our industry today, understand assessment and mitigation approaches and strategies, and learn processes and tools they can immediately apply in their work areas. The workshop will conclude with an interactive attendee Q&A panel discussion with regulatory and pharmaceutical industry experts to further enhance the participant’s understanding of data integrity expectations and compliance strategies.

NEW for 2017:

  • Learn from pharmaceutical industry and regulatory thought leaders about key issues in data integrity, including contributors, risks, and regulatory impact on your business
  • Engage and interact with peers in breakout sessions to identify key data integrity issues within your industry, using practical problem solving, case studies, and scenarios that simulate real-world industry conditions
  • Identify and deepen your understanding of effective data integrity practices and case studies

Core Workshop Topics

  • Data Mapping/Flow
  • Data Review/Forensic Tools focusing on chromatography in labs and use of audit trails in manufacturing
  • Data Integrity Governance including organizational maturity and cultural implications, developing metrics to enable the creation of a Data Integrity Governance checklist
  • Case Studies from the NEW ISPE GAMP® Guide: Records and Data Integrity

Schedule at a Glance

Sunday 04 June 2017

12:30 – 13.15 General Education Session
13.15 – 14.45 Concurrent Breakout Sessions
14.45 – 15.15 Networking Break
15.15 – 16.45 Concurrent Breakout Sessions
16.45 – 17.30 Industry and Regulatory Panel Discussion

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Presentations & Attendee Roster

Conference Attendees: