subject: Raps Pre-approved Webinar On configuration Management And Change Control For Computer Systems [print this page] Description: Description:
What happens when changes are made into computer systems? They bring with them problems relating to software, computer systems and networks. It is the same, whether the changes are made during design and development, or when the systems are being used.
Among the most frequently cited deviations during FDA inspections, too many changes of computer systems and failure to adequately document them rank high. There is uncertainty of documentation of initial set-up and managing changes later on among the users of systems; system owners and network administrators alike.
This webinar clears the misunderstanding professionals of computer systems have of what happens when changes made to the system are not backed by adequate documentation. Attendees of the seminar will receive clear recommendations and tools on how to configure and change computer systems in regulated environments.
This course will offer these reference materials for easy implementation:
oSOP: Change control of software and computer systems
oSOP: Handling security patches
oSOP: Change control of networks - planned and unplanned changes
oSix case studies
Areas Covered in the Session:
oUS FDA and EU requirements for change control
oDefining configuration management vs. change control and change management
oThe GAMP IEEE models for configuration management and change control
oHow to avoid frequent changes of a computer system
oReviewing a change control procedure
oChange control for hardware, operating systems and application software
oThe change control process for planned and unplanned changes
oDealing with security patches
oVersioning of software and computer systems
oWhat to test after changes
oHow to document changes
oGoing through examples for hardware, software and networked systems
Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. Ludwig is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of many books, including Validation and Qualification in Analytical Laboratories and Validation of Computerized Analytical and Networked Systems.
He also has more than 100 literature publications and conducts online tutorials regularly. His works speak of his erudition and deep understanding of everything that goes into FDA compliance. That Dr. Huber is a renowned expert on not only the FDA but also other regulatory bodies is evident from the fact that he has been Chief Advisor on Global ISO 17025 and FDA Compliance.
