Welcome to NewPressRelease.com a free press release service. Publishing press releases for Public Relations never been easier. Just register (it's free and it takes less then a 1 minute) then use Submit Press Release. Our services aim to help you reach journalists and to improve visibility in search engine listings, so you can get the most publicity possible.

Webinar On - Auditing for 21 CFR Part 11


(Free Press Release)

Webinar On - Auditing for 21 CFR Part 11


Scheduled On : Thursday, February 6, 2014 at 13:00 Hrs


This seminar will discuss the basics of Part 11 requirements and practical techniques for evaluation of the current compliance status of a given organization.  You will hear about validation plans, user requirements, test plans, test reports, change controls, standard operating procedures, data backup and business continuity. Case studies will be used to highlight common issues and potential solutions.

21 CFR Part 11 provides the basic framework for computer systems used to generate records and data used for analysis and presentation. Validated computerized systems are integral for producing accurate, reliable and consistent data. For many small to mid-sized organizations, meeting the regulatory requirements is a daunting task and Part 11 compliance is a major focus for audits. In this seminar, we will simplify the Part 11 requirements and provide practical tips in assessing computerized systems that will have you ready for your next audit.

Areas Covered in the Session :

  • Part 11 requirements by FDA
  • Validation of computer systems - Validation Plans, Requirements, Specifications, and Test Reports
  • Recommended SOPS
  • Change control
  • Data backup and business continuity
  • Compliance Assessment
  • Planning, preparing and executing audits
  • Common audit findings and tips for a successful audit

Who Will Benefit:

This webinar will provide valuable information to:


  • Anyone selecting computer systems intended for FDA regulated environments
  • Information technology professionals responsible for files or network locations
  • Quality professionals who organize, document and verify system compliance
  • Executives evaluating requirements Part 11 compliant systems

Webinar On - Auditing for 21 CFR Part 11

Source: Press Release



If you have any questions regarding information in this press release, please contact the person listed as the Author or use the contact informations published in the press release. Please do not attempt to contact NewPressRelease.com. We are unable to assist you with any information regarding this release. NewPressRelease.com disclaims any content contained in this press release. Please see our complete Terms of Service disclaimer for more information.

Related Items

All press release information on this site, including free press releases, is solely based on what our users submit. NewPressRelease.com disclaims that any right and responsibility for the information goes to the user who submit the press release. Some press release may be confusing without additional explanation. You should contact the provider with any questions about the information presented. In case some press release damages your benefits or violate your rights in any way, please contact us and we'll remove it immediately.

Copyright © 2008 - 2018 Free Press Release by NewPressRelease.com