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Fast Facts


Overview: Federal laws and regulations mandate to put controls and measures on a company network to ensure security and data integrity. Examples are 21 CFR Part 11, Sarbanes-Oxley Act, and HIPAA. With this legislation IT infrastructure and network qualification and compliance become a much more recognizable issue at higher levels of management. 

However currently there is no official guideline and the situation is similar to what happened with computer validation in early 90's and with early Part 11 issues. Until there will be an industry wide accepted approach companies either waste valuable resources because doing too much or take a risk to fail inspections because not doing enough or doing it wrong. With FDA's renewed focus on computer validation and IT systems, industry is looking for advice on how to comply for networks and infrastructure. 

This webinar will give a good understanding of FDA requirement and provide recommendations and tools for effective implementation.

Reference material for easy implementation:

  • Example: Network Infrastructure Qualification Plan
  • SOP: Risk Based Qualification of Network Infrastructure
  • SOP: Qualification of PC Clients
  • SOP: Qualification of Data Centers
  • SOP: Qualification of Servers
  • SOP: Handling Security Patches
Areas Covered in the Session:
  • Laws, regulations and guidelines- 21 CFR Part 11, HIPAA, Sarbanes-Oxley
  • FDA inspection/enforcement practices: examples for Warning Letters/483s
  • The FDA Industry Guide: Cybersecurity for Networks
  • The GAMP/ISPE Good Practices Guides and the IVT NIQ Standard
  • Principles and advantages of network infrastructure qualification
  • Compliance concepts for infrastructure vs. networked systems
  • Approaches and examples for risk assessment
  • Configuration management and change control: the most important steps 
  • Qualification of PC clients, servers, data centers 
  • What and how much to test with the risk based cost/benefits in mind
  • Handling security patches
  • Dealing with existing/legacy infrastructure
  • Considerations for network retirement
  • Dealing with infrastructure for 'CLOUD COMPUTING'
  • How to maintain the validate state during on-going use
  • Documentation requirements
  • Going through a life inspection
Who Will Benefit:
  • Analysts
  • Lab Supervisors and Managers
  • QA managers and personnel
  • Analysts
  • Consultants
  • Teachers

Price List:Live : $245.00Corporate live : $995.00Recorded : $295.00
Phone: 800-447-9407Fax: 302-288-6884

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Event Profile

Sponsors: GlobalCompliancePanel
Speakers: Dr. Ludwig Huber
Attendees: Analysts,Lab Supervisors and Managers,QA managers,Analysts,Consultants ,Teachers

Contact Details

Contact person: webinars
Event website:
Phone: 800-447-9407
Fax: 302-288-6884

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