[October 08, 2018] |
|
Computer System Validation: Reduce Costs and Avoid 483s - 2-day In-Person Seminar (Burlingame CA, United States - November 6-7, 2018) - ResearchAndMarkets.com
The "Computer
System Validation - Reduce Costs and Avoid 483s: 2-day In-person Seminar"
conference has been added to ResearchAndMarkets.com's
offering.
This Computer System Validation Training 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 Computer System Validation Training course is
intended for these regulated companies, software vendors, and SaaS/cloud
providers. The seminar instructor will:
-
Address the latest omputer 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 Objective:
-
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
Who Should Attend
-
Regulatory Affairs
-
QA/ QC
-
IT/IS
-
Software Managers
-
Project Managers
-
Software vendors and suppliers
For more information about this conference visit https://www.researchandmarkets.com/research/w97jcx/computer_system?w=4
View source version on businesswire.com: https://www.businesswire.com/news/home/20181008005533/en/
[ Back To TMCnet.com's Homepage ]
|