The Most Common Problems with Software Validation Processes
August 21, 2014 - Fremont CA USGlobalCompliancePanel
globalcompliancepanel@gmail.com
Phone:8004479407
Fax:302 288 6884
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