Common Problems with Software Validation Processes - Webinar By GlobalCompliancePanel

Event Details

Time: May 7, 2013 from 10am to 11:30am
Location: United States
Street: 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
City/Town: Fremont
Website or Map: http://bit.ly/YELqLk
Phone: 8004479407
Event Type: webinar, healthcare, medical, device, pharmaceutical, clinical
Organized By: GlobalCompliancePanel
Latest Activity: Apr 29, 2013

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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

David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications.

Price: $245.00

GlobalCompliancePanel

NetZealous LLC,
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA

USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

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