10times
logo
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.

Highlights

  • 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

Timings

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

Participants

20 Delegates
5 Exhibitors Estimated Count

Category & Type

Conference
Medical & Pharma
Education & Training

Editions

16-17 Sep 2019 Interested


Frequency Bi-annual

Official Links

Website Contacts


Report Error
Claim this event

Organizer

Logo Send Stall Book Request

ComplianceOnline USA

Top Rated 338 events listed
+ Add me as user

User Community [Users who have shown interest for this Event]

Guddi Patel

Guddi Patel

IT QA at Tesaro Waltham, United States

Visitor Ticket Price Buy Now

1699 USDAttendee Seminar One Registration
32.716000 -117.161000

Venue Map & Directions

google-map

Venue to be announced

San Diego, USA

Get Directions Add Venue

Featured Hotels in San Diego

More Hotels