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Event Type - Webinar

05 May 2021

05 May 2021

 

Verification vs Validation-Product, Process or Equipment and QMS Software     (72 Views)     

Event Serial No.-  WLD300918
Website  
Contact Person - Compliance4alllearning
Event inquiry /Organizer email address - [email protected]
Deadline for abstracts/proposals: 2021-05-05
Organized by: Compliance4alllearning View more Conference
Topic Covered: Medicine and Medical Science
Venue:

Fremont,  Ca,  United States of America


About Event


The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA. This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records""Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations. The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if "risk-based". How can this be done in the "real-world". This webinar will address software that is: As-Product In-Product Process andor In Production and Test Equipment and The Quality SystemCGMPs
 
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