Configuration Management and Change Control for Networks and Computer Systems

April 14, 2012 - PRLog -- Why to attend:
   
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 will learn how to document initial configurations and manage changes in regulated environments.          

Areas Covered in the Seminar:

*  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 of changes to hardware, firmware, software (operating system, application software), networks, documentation (specifications)

And for easy and instant implementation:
download 10+ documents from special seminar website.
They include

* SOP: Change control of software and computer systems
* SOP: Change control of networks - planned changes
* SOP: Change control of networks - unplanned changes
* SOP: Handling security patches
* SOP: Configuration management and version control of software
* Example: Identification of computer systems (Baseline Configuration)
* Example: Identification of network infrastructure and systems
* Six Case Sudies
* Master plan Computer System Validation (53 pages)
* FDA warning letters with deviations related to hange control

Date:  May 24,2012
Time: 11.00 - 12.00 a.m. EST
Location: Online, worldwide

Who should attend
* All companies generating electronic records in regulated environments
* Pharmaceutical and Device Manufacturers
* API Manufacturers
* IT administrators
* QA/QC managers and personnel
* Analysts and lab managers
* Validation specialists
* Regulatory affairs
* Consultants

Weblink:  http://www.labcompliance.com/seminars/audio/291/default.aspx

Presenter: Dr. Ludwig Huber

Category: Pharmaceutical, Device Manufacturer, FDA, Change Control