Two Day Seminar: 21 CFR Part 11 Compliance for SaaS/Cloud Applications: (Philadelphia, PA, United States - October 18-19, 2018) - ResearchAndMarkets.com
DUBLIN--(BUSINESS WIRE)--Sep 17, 2018--The “21 CFR Part 11 Compliance for SaaS/Cloud Applications: 2-day In-person Seminar” conference has been added to ResearchAndMarkets.com’s offering.
This interactive two-day course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.
Many companies outsource IT resources and are involved in 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 to avoid FDA form 483s and Warning Letters.
The seminar instructor will:Address the latest computer system industry standards for data security,data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Help participants understand the specific requirements associated with local and SaaS/cloud hosting solutions. Illustrate the importance of validating the quality process and every computerized system used in laboratory, clinical, and manufacturing settings. Demonstrate how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation. Review recent FDA inspection trends and discuss how to streamline document authoring, revision, review, and approval.
Learning Objectives:Understand what is expected in Part 11 and Annex 11 inspections Avoid 483s 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 validation documentation to reduce costs without increasing regulatory or business risk Write test cases that trace to elements of risk management Protect intellectual property and keep electronic records safe For more information about this conference visit https://www.researchandmarkets.com/research/fh3vdn/two_day_seminar?w=4
View source version on businesswire.com:https://www.businesswire.com/news/home/20180917005522/en/
Laura Wood, Senior Manager
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Related Topics:Software,Cloud Computing and Storage,Pharmaceutical Manufacturing
KEYWORD: UNITED STATES NORTH AMERICA PENNSYLVANIA
INDUSTRY KEYWORD: TECHNOLOGY SOFTWARE HEALTH PHARMACEUTICAL
SOURCE: Research and Markets
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PUB: 09/17/2018 11:52 AM/DISC: 09/17/2018 11:52 AM