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:



Validation


Quality Assurance


Engineering


IT


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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