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The Most Common Problems with Software Validation Processes

Event Details

The Most Common Problems with Software Validation Processes

Time: August 20, 2014 from 10am to 11:30am
Location: Online Event
Street: 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
City/Town: Fremont
Website or Map: http://bit.ly/1vmibg6
Phone: 18004479407
Event Type: webinar, pharma, medical, clinical, health
Organized By: GlobalCompliancePanel
Latest Activity: Jul 10, 2014

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Event Description

Overview:

This webinar covers the fundamentals of 21 CFR Part 11, software validation, and computer system validation. It provides details for company compliance including GAMP, qualification, and validation. It teaches the Part 11 industry standards for SOPs, security, data transfer, audit trails, and electronic signatures. The webinar details the common problems and how to avoid them.

Areas Covered in the Session:

  • Learn how to avoid 483 and Warning Letters.
  • Which software needs validation and which does not? 
  • Understand GAMP, qualification, and validation. 
  • Learn what the regulations mean, not just what they say.
  • Examine the regulatory requirements for the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation.
  • Understand the current computer system industry standards for security, data transfer, audit trails, and electronic signatures.
  • Learn the Who, What, Where, When, and Why of computer system validation.


Who Will Benefit:

  • IT
  • QA
  • QC
  • Laboratory staff
  • Managers
  • GMP, GCP, GLP professionals

Quick Contact:

GlobalCompliancePanel
USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
For More Info Click Here

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