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COMPUTER SYSTEMS VALIDATION & DATA INTEGRITY COMPLIANCE CONGRESS

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December 9 - December 11

Philadelphia, United States

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 40 Tutorials Addressing Today’s Top Challenges

 

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.

 

 

Agenda

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Faculty

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Sponsors


  • ecvalidation is a division of eConsulting company. We offer validation and qualification services of software, equipment, installations, rooms and processes. Our advantages are skills, knowledge and the qualifications of our team members. We have gathered vast experience through over 300 projects for clients from industries where quality assurance is of key importance. We also put a great emphasis on broadening our knowledge on new regulations, recommendations and best practices.
    Website: www.econsulting.pl
  • CIMINFO Software Inc. (CSI) provides a wide range of software solutions and compliance services that reduce costs and improve operational efficiency while complying with 21 CFR Part 11 and GxPs. CSI anticipates, defines, evaluates and solves the technical and regulatory issues that arise in a constantly changing environment to help clients achieve their business goals. The firm leverages 25 years of innovation, experience and knowledge in designing, developing and implementing technology solutions from the plant floor to the top floor.
    Website: https://part11solutions.com/contact-us/
  • PSC Biotech Corporation has three unique, active divisions within the parent company: our professional service division, PSC Biotech™; our software division, PSC Software™, and our contract manufacturing facility, BioTechnique. Each division is heavily rooted in regulatory expertise in order to meet the ever-changing needs of our clients around the globe.
    Website: https://www.biotech.com/

  • ROQMetrics is a Life Sciences CSV solutions and consulting firm with over 20 years of experience in global GxP compliance and technology. We offer innovative SaaS solutions to accelerate and elevate compliance of GxP applications using proven frameworks and methodologies. ROQMetrics helps with all aspects of validating computer systems from developing IT processes, SOPs, validation plans, risk assessment, test scripts, etc. ROQMetrics uses Lean-Agile practices to bring collaboration, continuous feedback, and improvement to the application lifecycle, resulting in more responsive and adaptive processes.
    Website: https://roqmetrics.com/

Partners

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Venue

Details

Start:
December 9
End:
December 11
Event Category:

Venue

Philadelphia
Philadelphia, PA United States + Google Map

Pricing & Registration

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