Data Integrity Overview—Good Documentation Practices for Electronic Data (10 December 2018)

IMG_5851 (1).jpg
IMG_5851 (1).jpg

Data Integrity Overview—Good Documentation Practices for Electronic Data (10 December 2018)

from 399.00

Webinar Monday, 10 December 2018, 11:00-12:30 pm ET (please register by COB 7 December 2018)

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*Please note: Each registration fee provides for a single log-in link at a single site, so groups must participate in a classroom-like arrangement.


This 90-minute webinar provides an overview of the key principles for assuring data integrity in GXP-regulated organizations and provides detailed examples of the foundational principles of Good Documentation Practices and how to apply these to both paper and electronic records.  Examples will be presented for GMPs (laboratory and production), GCPs, GLPs, and Medical Devices.  In addition, for those interested, this webinar offers an additional 30 minutes for Q&A upon completion of the webinar, from 12:30pm-1:00pm ET.

Example topics include:

       What is “Data Integrity”?

       Regulatory Update & Focus

       Key Quality Management System Controls

       High Level Overview of Data Life Cycle & Data Governance & Management Governance

       Paradigm Shift—paper to electronic

       21 CFR Part 11 as “Good Documentation Practices for Electronic Data”

       US FDA & EU Observations

       Q&A