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Course Agenda
Day One (8:30AM - 4:05PM)

8:00 – 8:30 AM: Registration

8:30 – 10:00AM:  What is Data Integrity (DI) 
  • Data integrity and related terms
  • Why is Data Integrity important
  • Data lifecycle and data states

10:00 – 10:15AM: Break

10:15 – 12:00 noon:  What is Data Integrity ….contd
  • The regulations for Data Integrity
  • Data Integrity attributes
  • Some DI related Warning Letters 

12:00 – 1:00PM: Lunch

1:00 – 1:45PM: Group exercise: Mapping DI

1:45 – 2:15PM: Considerations for a Corporate DI program
  • Corporate DI elements
  • Why DI problems occur
  • The 5-p model to address DI issues

2:15 – 2:35PM: Break

2:35 – 4:05PM: Corporate DI program ….. contd  
  • Elements of a Data Integrity Assurance plan
  • The SOPs for Data Integrity
  • Ethics SOP
Day Two (8:30 AM - 4:00PM)

8:30 – 10:00AM: Role of Risk Assessment in DI 
  • Identifying records vulnerable to DI
  • Assessing risk of identified records

10:00 – 10:15AM: Break

10:15 – 12:00 noon: Validating Data Integrity
  • How is DI validation different from Computer Systems validation
  • What to validate in order to fulfill the  regulations for DI

12:00 – 12:45PM: Lunch

12:45 – 1:30 PM: Group exercise: Develop test scripts to validate some DI regulations

1:30 – 2:15PM: Designing for Data Integrity
  • Specifying DI requirements
  • DI design and testing based on USE CASE

2:15 – 2:30PM: Break

2:30 – 4:00 PM: How is Data Integrity audited
  • What DI documents do auditors expect
  • Review Warning Letters to understand audit trends