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.

Break

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.

Lunch

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.

Break

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