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 States, Philadelphia, 400 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
Show more
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.
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
Show more
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.
