Conference & Events
Event Details
IT Infrastructure and Network Qualification: Step-by-Step - Webinar By GlobalCompliancePanel
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.
Date: 21 June 2012 10:00 - 11:15
Event Subject(s):
Biosciences
Education
General
Venue
Online Training
1000 N West Street
Delaware
Suite 1200
Wilmington
19801
United States of America
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Organiser Information
Organiser(s): GlobalCompliancePanel
Contact for Event Information
Address:
Online Training
1000 N West Street
Suite 1200
Wilmington
19801
United States of America
Tel:
800-447-9407
Fax:
302-288-6884
Email:
webinars@globalcompliancepanel.com
Contact Useful link:
http://www.globalcompliancepanel.com
Additional Information
Speaker Information:
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.
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Other information:
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 : $245.00
Corporate live : $995.00
Recorded : $295.00
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884
