Early Bird Pricing Ends May 24, 2024

VENUE

Hotel To Be Announced | Philadelphia, PA

LEAN VALIDATION
Computer Software Assurance Implementation
Digitalization Implementation & Validation

Computer Software Assurance and Digitalization has been evolving at a lightning pace over the past several years with FDA’s new guidance and the use of digital platforms and generative AI.  The time has never been more critical to evaluate your organization’s practices and explore opportunities to modernize your current processes.

Choose from Over 15+ Tutorials Addressing Today’s Top Challenges

COMPUTER SOFTWARE ASSURANCE IMPLEMENTATION

  • Conduct a Gap Analysis of Your Current Program and Transition to CSA
  • Scripted and Unscripted Testing – Requirements and Criticality Assessments
  • You’ve Transitioned to CSA, Now What? (Training Programs, Change Control, Continuous Monitoring)
  • Computer Software Assurance through Digitalization
  • Implications and Opportunities of CSA on Part 11 and Data Integrity
  • Agile Computer Software Assurance (CSA)
  • Case Study: Implementing CSA

PLUS!
A SPECIAL FOCUS ON DIGITALIZATION IMPLEMENTATION AND VALIDATION!

  • Human Centered Design – Soft Skills Needed for Digitalization
  • Going Paperless: Digitalization Implementation & Validation – A Case Study
  • Digital Threads and Data Integrity Governance
  • How to Use ChatGPT & Generative AI in Validation
  • Case Study: Implementing Machine Learning
  • Human Centered Design – Soft Skills Needed for Digitalization
  • Validation of Digital Twins – Understand Opportunities and Challenges

Personnel in the Following Environments Should Attend:

  • Validation
  • Quality Assurance
  • Engineering
  • IT
  • Data Integrity
  • Quality Control
  • Manufacturing Management
  • Regulatory Affairs

This event is also appropriate to business development and sales managers that offer innovative solutions for IT departments, validation departments, paperless validation platforms, and validation consultant services.

© Copyright 2020 Knowledge Exchange Network LLC. All Rights Reserved