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

precon

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

 

register

Day 1 | Day 2

Back to Top