2011 - IT Infrastructure and Network Qualification: Step-by-Step

This seminar will provide all information and tools on how to qualify network infrastructure for FDA compliance.

Why to attend:

Federal laws and regulations mandate to put controls and measures on a company network to ensure security and data integrity. Examples are FDA 21 CFR Part 11, Sarbanes-Oxley Act, and HIPAA. After an introduction to the requirements and to the principles of network qualification, the seminar will discuss all details on how to design, select, install and test networks for compliance. Attendees will receive a toolkit with SOPs, Templates and Examples for easy implementation.

Areas Covered in the Seminar:

* 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 Networked Medical Devices
* The GAMP/ISPE Good Practices Guides
* Principles of network infrastructure qualification
* Compliance concepts for infrastructure vs. networked systems
* Configuration management and change control
* Qualification of PC clients, servers, data centers
* What and how much to test
* Maintenance of servers
* How to ensure highest system uptime with on-line monitoring tools
* Documentation requirements
* Going through a life FDA inspection

Date: October 6,2011
Time: 11.00 - 12.00 a.m. EST
Location: Online, worldwide oder USA

Who should attend
* 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

Weblink: http://www.labcompliance.com/seminars/audio/276/de...

Presenter: Dr. Ludwig Huber

Category: Pharmaceutical, FDA, validation