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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.




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  • Fundamentally we exist for one reason: To accelerate our clients’ path to success. Our approach is simple; we put the client’s interests first. We don’t stop until it’s right. And we’ll do whatever it takes to get there.
    Website: https://commissioningagents.com
  • 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

  • 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/
  • A nationwide network of experts delivering professional services across the life sciences industry, Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 250 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest growing private companies in America, Azzur Group provides clients with the consulting, facility solutions, engineering, validation, IT, technical, training, and laboratory services and solutions they need to remain innovative and competitive.
    Website: https://www.azzur.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/

  • 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/
  • Novatek International’s mission is to produce regulatory compliant software solutions to the pharmaceutical, biotech and other health-care industries. Our goal is to improve patient safety by producing solutions that reduce the risks associated with pharmaceutical manufacturing and contribute to product quality.

    Website: https://ntint.com/
  • QACV offers comprehensive quality assurance, compliance, and computer validation consulting services to meet your regulatory needs. We provide professional consulting services to FDA regulated life science industries and use proven methodologies to achieve sustainable compliance for your organization.
    Website: http://www.qacvconsulting.com/
  • Global Leader in Paperless Validation
    Website: http://www.valgenesis.com/
  • Inspiring Operational Excellence through Best-in-Class CQV Processes
    Website: http://validation.org/


    More Information To Follow Soon



December 9
December 11
Event Category:


Philadelphia, PA United States + Google Map

Pricing & Registration

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