1st Edition  Conference

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

"The concepts behind 21CFR Part 11"
The FDA and other Health Authorities worldwide have focused their attention on data integrity, considering data integrity to be a significant risk to public safety. This is evident in the number of Warning Letter observations and related Import Alerts issued in the last 5-7 years. Data integrity is not a new topic, however, but is a part of the GMPs. Often, companies attempt to address data integrity issues procedurally and by conducting numerous training programs. These tend to be ineffective as data integrity issues are often rooted in a company's culture and may be very difficult to address.


  • Understand that data integrity is not now - the concepts behind 21CFR Part 11
  • Establish the relationship between company culture and data integrity,How to remediate
  • 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,Why data integrity is a focus by Health Authorities


8:30 AM - 4:30 PM (Sep 16) (General)
8:30 AM - 4:30 PM (Sep 17) (General)

Entry Fees

Paid Ticket Starts from 1699 USD View Details


20 Delegates
5 Exhibitors Estimated Count

Category & Type

Medical & Pharma
Education & Training


16-17 Sep 2019 Interested

Frequency Bi-annual

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Guddi Patel

Guddi Patel

IT QA at Tesaro Waltham, United States

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1699 USDAttendee Seminar One Registration
32.716000 -117.161000

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San Diego, USA

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