WORLD COMPLIANCE SEMINARS

Breakdown What FDA Requires in Assuring Data Integrity in the Life Science Industry

Retrieved on: 
Thursday, May 30, 2019
Data management, Information technology governance, Information technology management, Data integrity, Data quality, Transaction processing, Computing, Digital technology, Food and Drug Administration, Regulatory compliance, Data governance, Paperless office

Addressed will be development of a Data Integrity Policy, contents of Data Governance directives documents such as Code of Conduct, Roles and Responsibilities etc.

Key Points: 
  • Addressed will be development of a Data Integrity Policy, contents of Data Governance directives documents such as Code of Conduct, Roles and Responsibilities etc.
  • Our trainer, award-winning FDA data integrity compliance expert Chinmoy Roy , was a principal design architect of the world's largest biologics manufacturing facility.
  • This paperless manufacturing facility still continues to be the world's "gold standard" for data integrity, complete with a web of data integrity policies, directives and SOPs.
  • WCS addresses "how to" of data integrity and not the "what is" data integrity.