04 June 2013

Answers to the top five FDA software validation and documentation questions

Live Webinar hosted by Omnify Software



FDA and IEC requirements for validation of your manufacturing and quality system software can conjure up a lot of questions. Understanding the actual guidelines and best practices for meeting these requirements isn't always clear.


Please join us for an educational web seminar where we will provide answers to the top five most commonly asked questions  from FDA regulated companies about validation guidelines including: why documentation is important, what documentation is required for regulatory validation, and how to upgrade a validated system.


This webinar will cover

  • What is required to meet FDA Part 11 and Part 820.70 compliance
  • Why documentation is important
  • What documentation is required for regulatory validation
  • Why using canned documentation is not a best practice
  • How to upgrade a validated system
  • Best practices for meeting and maintaining compliant processes


Guest Speaker
Penny Goss, Compliance Specialist/Technical Documentation,

Penny Goss Technical Solutions

For the last 14 years Penny Goss has worked as a consultant and focused her business on verification and validation of technology controls and procedures to ensure compliance for businesses operating in regulated environments, primarily medical device, pharmaceutical and biotech companies regulated by the FDA, ISO & Sarbanes Oxley.


Event details

  • When: Wednesday, June 26, 2013
  • Where: Online
  • Time: 19.00 PM CET
  • Duration: 45 minutes
  • Cost: Complimentary
  • Registration: online


Get the answers to all of your FDA software validation questions.