How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud (NTZ)<br />At<br />DoubleTree by Hilton San Diego Downtown<br />For more information: https://www.eventbrite.com/e/how-to-be-efficient-compliant-w-part-11-validation-saascloud-ntz-tickets-52065375941?aff=RMV<br /><br />DESCRIPTION<br />=============<br />How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud<br /><br />This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments.<br />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. <br />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.<br /><br />Course Objectives:<br />====================<br />Understand what is expected in 21 CFR Part 11 and Annex 11 inspections<br />Avoid 483 and Warning Letters<br />Learn how to buy COTS software and qualify vendors.<br />Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds<br />Requirements for local, SaaS, and cloud hosting<br />How to select resources and manage validation projects<br />"Right size" change control methods that allows quick and safe system evolution<br />Minimize the validation documentation to reduce costs without increasing regulatory or business risk<br /><br />Please contact the event manager Marilyn below for the following:<br />- Discounts for registering 5 or more participants.<br />- If your company requires a price quotation.<br />Event Manager Contact: marilyn.b.turner(at)nyeventslist.com<br />You can also contact us if you require a visa invitation letter, after ticket purchase.<br />We can also provide a certificate of completion for this event if required.<br />----------------------------------<br /><br />For more information:https://www.eventbrite.com/e/how-to-be-efficient-compliant-w-part-11-validation-saascloud-ntz-tickets-52065375941?aff=RMV<br /><br />Eventbrite: https://www.eventbrite.com/o/event-promotions-by-new-york-events-list-11118815675<br />Twitter: https://twitter.com/nyeventslist<br />Facebook: https://www.facebook.com/NewYorkEventsList<br />New York Events List: http://nyeventslist.com/
