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Implementation and Qualification of a Risk-Based, Compliant and Secure Environment

June 11 - June 12

San Francisco, United States

Network Infrastructure & Cloud Qualification


FDA Warning Letters are on the rise within network infrastructures and the cloud. The time has never been greater to ensure these environments are qualified, controlled and Data Integrity compliant. Investments on compliance breaches are at a record high so best-in-class project management should be top priority of your organization. KENX is proud to present an event gives you the tools you need to project manage you and your organization through the development, implementation, and maintenance of a program that impresses FDA investigators. Topics to be discussed include:


  • Understand the Regulations and Benefits
  • Maintain Effective Change Management Processes
  • Cost Management while Excelling in Quality
  • Documentation Requirements for Qualification
  • Continued Network/Cloud Verification
  • Maintaining the Qualified State
  • Proactive Data Integrity Compliance
  • Monitor Cloud Environments for GDPR Compliance
  • IAAS, PAAS, and SAAS Processes and Controls
  • Assessment Checklist of Compliant Infrastructures
  • IQ/OQ/PQ of Infrastructure components
  • Service Provider and Vendor Audits
  • Cybersecurity – Address Malicious Threats
  • What to Do When Things Go Wrong – Disaster Recovery
  • Develop a Risk Management Approach
  • Configuration Management for Off-The-Shelf Software
  • Operating Systems and Servers


Personnel in the Following Environments Should Attend:

  • Information Technology/Systems
  • Quality
  • Validation
  • Database and System Administrators
  • Regulatory Affairs
  • Document Management
  • Engineering


This event is also appropriate to business development and sales managers that offer innovative solutions for IT, network infrastructures, the cloud and other software services.


More Information To Follow Soon


    More Information To Follow Soon





June 11
June 12
Event Category:


San Francisco, CA
San Francisco, CA United States + Google Map

Pricing & Registration

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