Configuration Management and Change Control for Computer Systems - Webinar By GlobalCompliancePanel November 14, 2012

Overview: It is well known that most problems of software, computer systems and networks are introduced when changes are made, either during design and development or during use of the systems.

Too many changes of computer systems and inadequate documentation of changes and testing after changes is one of the most frequently cited deviations during FDA inspections. Users of the systems, system owners and network administrators are unsure on how to document initial set-up and manage changes. Attendees of the seminar will receive clear recommendations and tools on how to configure and change computer systems in regulated environments.

Reference material for easy implementation:
SOP: Change control of software and computer systems
SOP: Handling security patches
SOP: Change control of networks - planned and unplanned changes
Six case studies

Areas Covered in the Session:
US FDA and EU requirements for change control
Defining configuration management vs. change control and change management
The GAMP IEEE models for configuration management and change control
How to avoid frequent changes of a computer system
Reviewing a change control procedure
Change control for hardware, operating systems and application software
The change control process for planned and unplanned changes
Dealing with security patches
Versioning of software and computer systems
What to test after changes
How to document changes
Going through examples for hardware, software and networked systems

Who Will Benefit:
IT Managers and System Administrators
QA Managers and Personnel
QC and Lab Managers
Validation Specialists
Regulatory Affairs
Training Departments
Documentation Department
Consultants

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.

Webinar By GlobalCompliancePanel

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

[email protected]
http://www.globalcompliancepanel.com

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Event Link - http://bit.ly/PD0CE5