[November 08, 2017] |
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Two Day Seminar: 21 CFR Part 11 Compliance for SaaS/Cloud Applications (Scottsdale, AZ, United States - January 31st, 2018 - February 1, 2018) - Research and Markets
The "21
CFR Part 11 Compliance for SaaS/Cloud Applications: 2-day In-person
Seminar" conference has been added to Research and
Markets' 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 (News - Alert)) 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.
This course is intended for these regulated companies, software vendors,
and SaaS/cloud providers.
The seminar instructor will:
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Address the latest computer system industry standads for data
security,data transfer, audit trails, electronic records and
signatures, software validation, and computer system validation.
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Help participants understand the specific requirements associated with
local and SaaS/cloud hosting solutions.
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Illustrate the importance of validating the quality process and every
computerized system used in laboratory, clinical, and manufacturing
settings.
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Demonstrate how to decrease software implementation times and lower
costs using a 10-step risk-based approach to computer system
validation.
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Review recent FDA inspection trends and discuss how to streamline
document authoring, revision, review, and approval.
Learning Objectives:
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Understand what is expected in Part 11 and Annex 11 inspections
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Avoid 483s and Warning Letters
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Learn how to buy COTS software and qualify vendors
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Implement a computer system using risk-based validation to gain
maximum productivity and reduce cost by as much as two thirds
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Requirements for local, SaaS, and cloud hosting
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How to select resources and manage validation projects
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"Right size" change control methods that allows quick and safe system
evolution
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Minimize the validation documentation to reduce costs without
increasing regulatory or business risk
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Write test cases that trace to elements of risk management
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Protect intellectual property and keep electronic records safe
Who Should Attend:
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Regulatory Affairs
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QA/ QC
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IT/IS
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Software Managers
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Project Managers
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Software vendors and suppliers
For more information about this conference visit https://www.researchandmarkets.com/research/vtst3w/21_cfr_part_11
View source version on businesswire.com: http://www.businesswire.com/news/home/20171108005780/en/
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