Monday, 07. December 2020, Wyndham Philadelphia Historic District, Computer Systems Validation & Data Integrity Compliance Congress - December 2020

from 07. December 2020 - 17:00
till 10. December 2020 - 2:00

Wyndham Philadelphia Historic District

Wyndham Philadelphia Historic District
United StatesPhiladelphia400 Arch Street
Event description
Implement Programs that are Compliant, Smart and Progress with Today’s Evolving Technology


The FDA has issued many Warning Letters emphasizing CSV non-compliance. These serious findings include; 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 Washington, D.C. and showcases the protocols, methodology and actions necessary to avoid regulatory action.


Choose from Over 30 Tutorials Addressing Today’s Top Challenges

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Computer Systems Validation

Conduct a CSV Audit Enterprise-Wide and Develop a Master Plan

Perform Risk Assessments on Complex Systems

Understand Documentation Requirements for Validation

Confirm Accurate Processing, Control and Reporting of Electronic Records

Develop an Effective CSV Corrective Action and Preventive Action (CAPA) Program

Audit and Validate Paper, Electronic and Hybrid Systems

Streamline Processes with Innovative E-Validation Solutions

Write IQ/OQ/PQ Procedures, User Requirements and Test Scripts for New Systems

Learn Best Practices for Change and Configuration Management

Qualify Cloud Infrastructures & Mobile Devices

Understand How to Validate Excel™ Spreadsheets


Data Integrity Compliance

Develop, Implement and Maintain Data Integrity Protocols Enterprise-Wide

Learn the Methodology and Techniques Used to Identify Inaccuracies

Conduct an Audit Enterprise-Wide

Ensure the Reliability and Completeness of Analytical Data

Identify and Investigate Root Causes of Integrity Lapses

Know the Expectations for and Handle Issues in the Analytical Lab

Perform a Risk Assessment for Deficiencies

Understand Requirements and How to Handle Audit Trails


Personnel in the Following Environments Should Attend:


Quality Assurance



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.


Computer Systems Validation & Data Integrity Compliance Congress - December 2020, Wyndham Philadelphia Historic District event

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