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Live Webinar


IT Infrastructure and Network Qualification: Step-by-Step

Course "Efficient IT Infrastructure and Network Qualification: Step-by-Step" has been pre-approved by RAPS as eligible for

up to 1.25 credits towards a participant's RAC recertification upon full completion.

Date & Time:


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Instructor Profile:

Thursday, June 21, 2012

10:00 AM PDT | 01:00 PM EDT

Duration: 75 Minutes

Instructor: Dr. Ludwig Huber

Location: Online

Price : $245.00

Dr. Ludwig Huber Chief Advisor - Global FDA compliance, Agilent Technologies

(for one participant)

Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. ...more

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

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Your Necessity is our Priority

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.

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Example: Network Infrastructure Qualification Plan





SOP: Handling Security Patches

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Risk Based Qualification of Network Infrastructure Qualification of PC Clients Qualification of Data Centers Qualification of Servers

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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

Click here to register for this webinar Who Will Benefit: l l l l l l

Analysts Lab Supervisors and Managers QA managers and personnel Analysts Consultants Teachers

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

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IT Infrastructure and Network Qualification: Step-by-Step  

Federal laws and regulations mandate to put controls and measures on a company network to ensure security and data integrity. Examples are 2...