FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers


8:30 a.m. – 9:00 a.m.

Registration and Continental Breakfast

9:00 a.m. – 9:15 a.m.

Introduction and Welcome

9:15 a.m. – 10:45 a.m.

Data Integrity: What’s Really Required?

  • Core regulatory requirements FDA, EMA, Health Canada and more
  • Overlooked guidances what you don’t know will hurt you
  • How to quickly parse warning letters for data integrity expectations
  • FDA investigator tactics and questions about your data integrity
  • Interactive Hands-On Exercise: Attendees act as FDA investigators in different company types to find the data integrity controls FDA expects during an inspection

10:45 a.m. – 11:00 a.m.


11:00 a.m. – 12:00 p.m.

Suppliers and Data Integrity: Who’s Actually Accountable?

  • FDA’s view accountability versus responsibility
  • Dealing with your regulated data at critical suppliers
  • Contractual components to address data integrity risks
  • Handling SaaS providers, hosted IT systems and cloud computing
  • Managing data integrity with CROs and outsourced clinical sites
  • Overseeing data integrity at your CMO and contracted services
  • Addressing data from suppliers of raw materials
  • Interactive Hands-On Exercise: Attendees act as FDA investigators to review the data integrity controls from several case study companies have in place over their suppliers should the sponsor/purchaser get a warning letter?

12:00 p.m. – 1:00 p.m.


1:00 p.m. – 2:15 p.m.

Practical Realities: The Business Costs of Poor Data Integrity

  • Real world business costs of poor data integrity
  • Legal pitfalls for senior management from poor data integrity
  • Practical quality costs of poor data integrity
  • Interactive Hands-On Exercise: Attendees review several case studies to determine costs and dangers of poor data integrity

2:15 p.m. – 2:30 p.m.


2:30 p.m. – 4:30 p.m.

Critical Data Integrity Elements to Prove Compliance

  • Eight practical elements of data integrity (ALCOA+ in practice)
  • Narrowing the scope
  • Risk-based data integrity controls a simplified approach
  • Verifying data integrity controls at suppliers
  • Qualifying personnel from CV to training
  • Defining roles and responsibilities
  • Conducting quality audits of data integrity what to look for and why
  • Monitoring, metrics and communication
  • Policies and SOPs to consider
  • Scanning, true copies and source data
  • Interactive Hands-On Exercise: Using case studies, attendees identify likely risks and select the most appropriate controls for each situation

4:30 p.m. – 5:00 p.m.

Day One Wrap Up and Review

  • Interactive Hands-On Exercise: Attendees identify 3 compelling reasons for their own company to adopt data integrity controls now



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