Raps Pre-approved Webinar On configuration Management And Change Control For Computer Systems

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

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When:November 14, 10:00 AM PDT | 01:00 PM EDT

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By whom:

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.

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For whom:

This webinar will benefit

oIT Managers and System Administrators

oQA Managers and Personnel

oQC and Lab Managers

oValidation Specialists

oRegulatory Affairs

oTraining Departments

oDocumentation Department

oConsultants

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Duration:75 minutes

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To enroll for this webinar, contact

webinars@globalcompliancepanel.com

Phone: 800-447-9407

ARTICLE LINK

by: GlobalCompliancePanel

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