IT Infrastructure and Network Qualification- Introduction and Strategies for Compliance and System Uptime

Why Should You attend:

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 FDA's renewed focus on computer validation and IT systems, industry is looking for advice on how to comply for networks and infrastructure.

Areas Covered in the seminar:

• Laws, regulations and guidelines- 21 CFR Part 11, HIPAA, Sarbanes-Oxley.
• The FDA Industry Guide: Cyber security for Networked Medical Devices.
• The GAMP/ISPE Good Practices Guide.
• The IVT proposed NIQ standard.
• Principles of network infrastructure qualification.
• Compliance concepts for infrastructure vs. networked systems.
• Configuration management and change control as the most important network qualification steps.
• Qualification of PC clients, servers, data centers.
• What and how much to test with the risk based cost/benefits in mind: network components, servers, PC clients, applications, initial vs. on-going testing.
• How to ensure highest system uptime with on-line monitoring tools
• Documentation requirements.
• Going through a life inspection.
• Software tools for infrastructure qualification.

Who will benefit:

• IT managers and personnel
• Everybody responsible for FDA compliance of computer systems
• Managers from purchasing, documentation and operations
• All users of computer systems used in regulated environments
• QA managers and personnel
• GLP/GMP/GCP auditors
• Consultants
• Teachers

Instructor Profile:

Ludwig Huber, is one of the leading experts on validation and compliance issues for laboratories. He is the worldwide director for FDA Compliance at Agilent Technologies. A frequent speaker at industry gatherings, Dr. Huber was voted the ‘Presenter of the year’ from among 170 experts by more than a 1000 IVT (http://www.ivthome.com/) conference attendees in 2002. Dr. Huber has conducted over a 100 on-line audio/tele/video seminars and is the author of the books “Validation and Qualification in Analytical Laboratories” and "Validation of Computerized Analytical and Networked Systems", Interpharm Press.

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