Tags » Computer System Validation

Webinar On Learning from Recent FDA Warning Letters related to Part 11 and Computer Validation

Scheduled On : Thursday, May 7, 2015 at 13:00 Hrs

Description :

Some time ago FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, now it looks more like an ongoing program with Part 11 related issues being part of most inspection. 328 more words

Life Science

Webinar On FDA’s 21 CFR Part 11 Add-on Inspections

Scheduled On : Tuesday, March 24, 2015 at 13:00 Hrs

Description :

This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. 246 more words

Life Science

Webinar On Computer System Validation

Scheduled On : Wednesday, March 4, 2015 at 13:00 Hrs

Description :

This course provides a background to CSV regulations and guidance on the overall process of validation and the importance of good documentation. 336 more words

Life Science

5 Life Sciences Technology Strategy Considerations for 2015

  1. Have you assembled the appropriate project team to implement a life sciences application?

The nature of projects and outsourcing today is composed of complex global projects managed by virtual teams and project variance. 888 more words

Webinar On Risk Management Principles

ICH Q9 Quality Risk Management issued in 2009 laid out the basic principles for risk management to be utilized in all areas of the pharmaceutical industry including clinical trials but also manufacturing, computer system validation etc.. 199 more words

Life Science

GxP in Computer System Validation

GxP in Computer System Validation.

GxP (Good X Practice, where according to FDA compliance; X can mean Clinical, Laboratory, Manufacturing, Pharmaceutical, etc., and used according to the situation in which they occur) in Computer System Validation occupies a position of primacy in the field of technology because of various reasons. 281 more words


Live webinar on FDA’s 21 CFR Part 11 Add-on Inspections

In December 2010 the FDA began a project to better understand the industry’s adherence (or lack thereof) to 21 CFR Part 11. This involves the add on’ surveillance inspections of the sponsors’ computer systems during the course of the FDA’s regular inspections. 261 more words

Life Science