How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud (NTZ)
At
Four Points by Sheraton Boston Logan Airport Revere, MA
Boston, MA
For more information: https://www.eventbrite.com/e/how-to-be-efficient-and-compliant-with-part-11-validation-and-saascloud-ntz-tickets-42986984227?aff=RMV
DESCRIPTION
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How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud
This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.
Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers.
Course Objectives:
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Understand what is expected in 21 CFR Part 11 and Annex 11 inspections
Avoid 483 and Warning Letters
Learn how to buy COTS software and qualify vendors.
Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
Requirements for local, SaaS, and cloud hosting
How to select resources and manage validation projects
"Right size" change control methods that allows quick and safe system evolution
etc..
Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If your company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
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For more information: https://www.eventbrite.com/e/how-to-be-efficient-and-compliant-with-part-11-validation-and-saascloud-ntz-tickets-42986984227?aff=RMV
Eventbrite: https://www.eventbrite.com/o/event-promotions-by-new-york-events-list-11118815675
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