Earn 1.5 credit unit hours by registering for this course!

By taking this on-demand course, you’ll be able to earn 1.5 credit unit hours.  Once registered, KENX will send your log-in to our virtual conference which contains the designated Temple University sessions. 

Take every designated Temple session on your time, the schedule is completely up to you!

You can also earn credits through our other courses such as Laboratory University and Validation & GMP University

To this day, CSV and Data Integrity challenges remain high in our rapidly changing environment. In fact, FDA and other regulators continue to find serious findings including; having 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. KENX is pleased to announce that our comprehensive CSV & DI Congress is headed to Philadelphia, PA, and showcases the protocols, methodology and actions necessary to avoid regulatory action.

Choose from Over 40+ Tutorials Addressing Today’s Top Challenges

COMPUTER SYSTEMS AND SOFTWARE VALIDATION

• Develop a Compliant-Winning Strategy to Migrate Electronic Records
• Understand FDA’s CSA Expectations and Proposed Draft
• Implement Process Mapping for IT Infrastructures
• Learn Machine Learning and AI Validation Techniques
• Conduct Risk-Based Impact Assessments and Continuous Monitoring
• Understand Pharma 4.0 and the Impact of Digitalization and IoT to CSV
• Implement Risk Management in Cloud-Based Exchange Systems
• Modernize the Periodic Review Process
• Overcome MS Excel Spreadsheet Validation
• Validate Cloud-hosted Systems and Network Infrastructures

DATA INTEGRITY GOVERNANCE AND INSPECTION READINESS

• Conduct a Thorough and Accurate Gap Assessment
• Identify Gaps and Investigate Root Causes of Lapses
• Construct of a Program from the Ground Up
• Understand the Impact of Human Performance – Transform the Culture
• Implement an Effective Audit Trail Review Process
• Conduct a Risk-based Remediation
• Implement a CAPA Process – What to Do When Things Go Wrong
• Manage Corporate Challenges and Define Clear Roles and Responsibilities
• Learn How to Effectively Document Risks

Personnel in the Following Environments Should Attend:

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

This event is also appropriate to business development and sales managers that offer innovative solutions for quality departments, validation departments, data collection and statistics.