Computer Systems Validation & Software Assurance University, Philadelphia, PA

With FDA’s heightened focus on Software Assurance and Data Integrity – Computer Systems Validation has taken on a new movement initiated by regulatory authorities. In fact, FDA has taken the lead with a proposed guidance on Computer Software Assurance and is asking firms to rethink their approach. With that said, the challenges remain high in our rapidly changing environment

In fact, inspectors continue to find serious findings such as – interrupted, missing, deleted and lost data, inadequate records for risk analysis, failure to exercise appropriate controls, failure to validate computer software, failure to establish validation procedures, manipulation and deletion of audit trails, and many more. The time has never been more critical to evaluate and ensure your organization has top-notch compliant procedures.

CEO & Founder of AmpleLogic, Mr. Manne V Chowdary will discuss and provide key insights on “CSV/CSA, Tweak V-Model to accelerate Digitalization in Pharma.”

Key Industry Leaders at the Event: 

  • Louie Rayal, Senior Director – IT Quality and Compliance, Abbott
  • Calvin Kim, Head of Quality Systems and Validation, Samsung Biologics
  • Lizzandra Rivera, Director IT Quality, Alexion Pharmaceuticals
  • Pritam Khade, Director, Global Quality Compliance, AbbVie
  • Joanne Goldberg, Sr. Principal Quality Systems Specialist, Medtronic
  • Joseph Zec, Ass.Director, Information Systems, Vertex Pharmaceuticals
  • Ken Shitamoto, Executive Director, Gilead Sciences
  • Kalpesh Patel, Associate Director, QA, BioGene
  • Laura Berberian, Manager, Quality Assurance Validation, ElevateBio
  • Brian DiVista, Ass. Director, Computer Systems Validation, ElevateBio and many more…..
List of Speakers at Kenx Hybrid Conference

Stay in Touch

Follow Us