21 CFR Part 11 and QMS Software Risk-Based Implementation

Posted By : User Ref No: WURUR65917 0
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  • TypeWebinar
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  • Location Palo Alto, California, United States
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  • Date 16-12-2020
Webinar Title
21 CFR Part 11 and QMS Software Risk-Based Implementation
Event Type
Webinar
Webinar Date
16-12-2020
Last Date for Applying
16-12-2020
Location
Palo Alto, California, United States
Organization Name / Organize By
Complianceonline
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Complianceonline
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Organization/Company
WebinarCategory
Both (Technical & Non Technical)
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All (State/Province/Region, National & International)
Related Industries
Location
Palo Alto, California, United States

CGMP-compliant companies must develop / implement formal software controls and usage, starting with proper verification and validation methods. This is an important consideration for a company’s Quality Management System (QMS) and must consider applicable elements of electronic records / signatures / Part 11. The US FDA recently added data integrity and cybersecurity to these requirements. These activities must be properly documented.

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Website
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  2479 E. Bayshore Road, Suite 260,City- Palo Alto, State- CA, Country – United States  Pin/Zip Code : 94303
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California
Official Email ID
Contact
Ashutos Swain