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16-Sep-2019 - 17-Sep-2019

Identify and Manage Data Integrity Issues, CSV and 21 CFR Part 11

  • Location:
    • Venue to be announced shortly
    • San Diego
    • CA
    • 22434
    • United States
  • View on a map

Learning Objectives:

  • Understanding what data integrity is
  • Why data integrity is a focus by Health Authorities
  • Understand that data integrity is not now - the concepts behind 21CFR Part 11
  • Establish the relationship between company culture and data integrity
  • Understand how data integrity relates to computerized system implementation and usage
  • Applicability of data integrity to legacy systems
  • Relationship between print outs and meta data
  • How to conduct a data integrity risk assessment
  • How to audit for data integrity issues
  • How to mitigate data integrity risk
  • How to remediate data integrity issues
 

Areas Covered :

  • Regulatory basis for data integrity enforcement
  • Cultural basis for data integrity issues and difficulty to effect culture change
  • Assessing data integrity risk and mitigation
  • How to audit for data integrity issues
  • How to remediate
 

Who will Benefit:

This Data Integrity Training course is intended for Life Science companies such as pharmaceutical manufacturers (both drug substance and drug product), medical device manufacturers, and those companies conducting or sponsoring clinical trials. In addition to these regulated companies, this course will be of value to those responsible for data integrity compliance.

  • QA/ QC managers and supervisors
  • IT Managers and System Administrators
  • Project Managers and Supervisors
  • Manufacturing Managers and Supervisors
  • Software developers, vendors, and suppliers
  • Regulatory Affairs
  • Training departments
  • Consultants