Contact Info
701 E Santa Clara Street Suite 42
Ventura, CA 93003
Follow Us

CS Assure

KENX CSV and DI Congress December 2019

Conference Highlights


Being a Gold Sponsor of the KENX Computer System Validation and Data Integrity Congress, it’s both our honor and responsibility to share highlights from the event. The conference was attended by life sciences industry leaders, experts and professionals from across the globe.


The KENX Computer System Validation and Data Integrity conference held in Philadelphia, PA, December 9th – 11th, was packed with lots of great content and interactive workshops from preparation for FDA computer systems inspections to cutting edge topics like machine learning and artificial intelligence. There were so many compelling competing topics; it was hard at times to choose which one to attend. The good news is that all of the presentations are available to the attendees online.


Below we’ve highlighted three standout presentations and an amazing announcement, but believe us; there were more!  Please note, the content of this article is NOT official guidance from the FDA or any other person or organization mentioned in this article.  It is simply a recap of some of the standout and informative sessions.


Philanthropic Annoucement


John Kirchner, Executuve Director at KENX made the following announcement.  “KENX partners with Temple University’s RA/QA graduate program to assist professionals working in life sciences who are helping to shape our future for patient outcomes, safer drugs, compliant processes and innovative technology.  KENX is happy to report that we have donated nearly $60,000 to Temple University’s RA/QA graduate program to date” . – John Kirchner


Compliance Intelligence – Stay Up to Speed with FDA’s Proposed Computer Software Assurance Draft Guidance.


This panel discussion covered the cultural barriers of transitioning from CSV to CSA and the paradigm shift necessary to transition successfully.   A key takeaway from the panel discussion was that less is sometimes more.  For example, a key suggested paradigm shift is to flip CSV upside down and focus on high-risk testing items versus documentation.  Many organizations see validation as a documentation exercise.  This misperception must be changed.  

A second key takeaway stressed by the panel is to stop essessively taking screenshots as evidence during testing.   Of course this one came with a bit of skepticism 🙂


The third teakeaway was a result of a real-time poll.  The panel polled the audience to understand how many attendees relied heavily on scripted testing.  At the start of the session the majority reported that they relied mostly on scripted testing.  By the end of the session, the poll showed that many are now intersted in taking  advantage of unscripted/exploratory testing.


The panel included Senthil Gurumoorthi, Associate Director at Gilead Sciences, Khaled Moussally, Head of Quality at Compliance Group, Jason Spiegler, Sr. Director at Siemens Digital Industries Software Inc., Ken Shitamoto, Senior Director at Gilead Sciences, and Francisco (Cisco) Vicenty, Consumer Safety Officer, at CDRH, U.S. FDA.


Preparation and Management of FDA Inspections of Computer Systems and Data Integrity.


Chris Wubbolt, Principal Consultant at QACV BioPharma Group, walked the audience through the FDA inspection process from preparation to closure and provided real-world experiences and tips to ensure a successful inspection. A key takeaway from Chris’s presentation was to be truthful and answer questions from the FDA inspector unambiguously. As a bonus, an actual FDA inspector was present during Chris’ presentation to provide further context from an FDA point of view.


Machine Learning (ML) and the future of Computer Systems Validation.


Rosalind Beasley, Digital Transformation Leader, Healthcare & Life Sciences, ROQMetrics, Inc., provided the audience with a 3-hour crash course in AI and machine learning starting with what It means to learn and culminating in a live demonstration of machine learning in life sciences. The audience was presented with a machine learning use case and asked to resolve some critical validation challenges along the way. A key take away from Rosalind’s presentation was to beware of data quality issues and biases in data as you embark on your AI journey.


What’s Next?


All in all, the three-day conference was time well spent with an energetic group of life science thought leaders eager to share experiences and best practices in computer systems validation and data integrity. We are looking forward to the next KENX Validation University in 2020!

[qodef_button size=”” type=”” text=”Validation University 2020 – Take a sneak peek here! ” custom_class=”” icon_pack=”font_awesome” fa_icon=”” link=”” target=”_self” color=”” hover_color=”” background_color=”” hover_background_color=”” border_color=”” hover_border_color=”” font_size=”” font_weight=”” margin=””]

Post a Comment