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Computer System Validation: Reduce Costs and Avoid 483s - 2-day In-Person Seminar (Burlingame CA, United States - November 6-7, 2018) - ResearchAndMarkets.com

October 8, 2018

DUBLIN--(BUSINESS WIRE)--Oct 8, 2018--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) 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 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 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/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Manager

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Related Topics:Pharmaceutical Manufacturing

KEYWORD:

INDUSTRY KEYWORD: TECHNOLOGY DATA MANAGEMENT SOFTWARE PRACTICE MANAGEMENT HEALTH PHARMACEUTICAL

SOURCE: Research and Markets

Copyright Business Wire 2018.

PUB: 10/08/2018 10:56 AM/DISC: 10/08/2018 10:56 AM

http://www.businesswire.com/news/home/20181008005533/en

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