In 1991 the pharmaceutical industry met with FDA to determine how best to accommodate paperless record systems under CGMP regulations. The final result, published in 1997, was 21 Code of Federal Regulations Part 11. It provides industry with quantitative information for electronic records and signatures that can be used to add value to the validation of automated systems. Part 11 regulations can be used to accomplish three tasks: create new requirement specifications that comply with Part 11 regulations, assess existing automated systems for Part 11 compliance, and remediate Part 11 compliance gaps in existing automated systems.
In this audio conference, attendees learn how they can quickly and easily assess and remediate their current systems for Part 11 compliance, and how to add value by incorporating Part 11 into the validation effort.
21 CFR Part 11: Gap Analysis, Remediation & Adding Value to Validation is being presented by Jeffrey Gassman, President & Founder, of Validation Plus, Inc. and airs on Thursday, July 16, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com
