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Event Type - Webinar

10 Mar 2021

10 Mar 2021

 

Best Practices in Preparation for an FDA Computer System Audit     (274 Views)     

Event Serial No.-  WLD218618
Website  
Contact Person - compliance4alllearning
Event inquiry /Organizer email address - [email protected]
Deadline for abstracts/proposals: 2021-03-10
Organized by: compliance4alllearning View more Conference
Topic Covered: Medicine and Medical Science
Venue:

Online Event,  Ca,  United States of America


About Event


Overview: As a "GxP" system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records andor electronic signatures ERES are incorporated into the system, FDAs CFR Part 11 guidance on ERES must be followed. This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle SDLC methodology is the best approach for computer system validation and maintaining data integrity.
 
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