How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud

Date : 4th February 2019 to 5th February 2019

Place : United States, Boston

Website :https://www.globalcompliancepanel.com/seminar/how-to-be-efficient-and-compliant-with-part-11-validation-and-SaaS-Cloud-901921SEMINAR?allconferencealerts-seo

Contact Person:Event Manager

Description:

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. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.

How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud will be held in Boston,United States on date 2019-02-05

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Deadline for abstracts/proposals : 4th February 2019

Keynote Speakers : Carolyn Troiano Consultant, BrainStorm Central Consulting Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), an

Conference Highlights :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 Minimize the validati

Venue :Four Points by Sheraton Boston Logan Airport Revere, Squire Road, Revere, MA, USA

Check the event website for more details.