8:30 a.m. – 9:00 a.m.

Continental Breakfast

9:00 a.m. – 9:15 a.m.

Day Two Welcome and Quick Learning Recap

9:15 a.m. – 10:30 a.m.

Modern Validation Protocol

• Validation by risk level — it’s all about the data
• Sampling and test cases — FDA’s view
• FDA’s view of supplier-provided validations
• Taking advantage of the traditional DQ\IQ\OQ\PQ format
• Example FDA-“approved” test cases for data integrity-based validation
• Interactive Hands-On Exercise: Attendees review case study validation tests to see if data integrity is actually being verified

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:00 p.m.

Mapping Your Data Chain-of-Custody

• Data mapping defined
• Steps to map your data flow across the data lifecycle
• Benefits to mapping your chain-of-custody — business and the FDA
• Interactive Hands-On Exercise: Work in teams to data map a sample data flow from several case studies (one cGCP and one cGMP)

12:00 p.m. – 1:00 p.m.

Lunch

1:00 p.m. – 2:15 p.m.

Advanced Tactics to Cut Costs and Reduce Your Workload

• Change management — from preapproved to emergency
• Containing costs with cross-functionality
• Incorporating data integrity compliance into the day-to-day operations of departments and supervisors
• Creating a site master data integrity compliance plan
• Data integrity governance
• Interactive Hands-On Exercise: Draft a communication to be sent out by your senior team to all company employees about good data integrity that will actually lower your workload and encourage self-compliance

2:15 p.m. – 2:30 p.m.

Break

2:30 p.m. – 3:30 p.m.

Data Integrity, Recordkeeping and Archival Controls

• Records to retain to prove good data integrity controls
• Basics of bit rot and other risks to archived data
• Developing a media migration strategy
• Qualifying record/archival storage vendors
• Interactive Hands-On Exercise: Attendees work in teams to outline a sample set of data integrity controls and auditing plans for several case study companies

3:30 p.m. – 4:00 p.m.

Building Your Business Case for Defensible Data Integrity

• Quick tips for talking to senior management about data integrity
• A sample data integrity action plan — nine brainstorming questions
• Interactive Hands-On Exercise: Attendees work with the expert instructor to draft their own personal, business case and prioritized plan for implementing a data integrity control framework at their company

4:00 p.m. – 4:30 p.m.

Wrap Up and Final Questions

4:30 p.m.

Adjournment