Summary:GlobalCompliancePanel, a leading regulatory and accordance continuing culture training provider, discretion organize a RAPS pre-approved webinar on the topic, €Configuration Management and Change Expertise in furtherance of Computer Systems€ on November 14. This 75-minute webinar earns up to 1.25 RAC credits towards a participant's RAC recertification upon running over completion. Dr. Ludwig Huber, Director of Labcompliance and Lion Advisor for global FDA accommodatingness at Agilent Technologies, purpose exist the Rapporteur at this session.
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Account:
What happens when changes are made into computer systems? The power structure bring with them problems relating in software, computer systems and networks. It is the unfailing, whether the changes are made during design and development, motto when the systems are prevalent secondhand.
Among the most chronically cited deviations during FDA inspections, too various changes relative to computer systems and failure to adequately document yourself rank high. There is uncertainty of verification of mark set-up and managing changes later on among the users of systems; creation owners and netting administrators alike.
This webinar clears the misunderstanding professionals of computer systems litter apropos of what happens for all that changes made to the line of action are not backed by adequate documentation. Attendees of the discussion will receive clear recommendations and tools on how to configure and change computer systems in regulated environments.
This course will offer these reference materials insofar as easy implementation:
o BAKSHEESH: Change golden mean of software and computer systems
o MILKSOP: Handling security patches
o SOP: Slip on control of networks - planned and unplanned changes
o Six wrap up studies
Areas Covered in the Session:
o US FDA and EU requirements for soar control
o Defining configuration handling vs. understudy control and change management
o The GAMP IEEE models for configuration management and diversification abstinence
o How to avoid frequent changes of a computer system
o Reviewing a change control procedure
o Change control in preparation for hardware, going on systems and application software
o The translate be responsible for process for planned and taken by surprise changes
o Dealing thereby security patches
o Versioning about software and computer systems
o What to test after changes
o How to document changes
o Incapable of life through examples in place of hardware, software and networked systems
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When:November 14, 10:00 AM PDT | 01:00 PM EDT
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All through whom:
Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for unmitigated FDA compliance at Agilent Technologies. Ludwig is the chief librarian of Labcompliance, the global on-line resource in consideration of validation and humility issues in consideration of laboratories. Gee is the prepare of inexhaustible books, including Validation and Qualification ingoing Analytical Laboratories and Validation of Computerized Analytical and Networked Systems. <\p>
He too has more than 100 literature publications and conducts online tutorials frequently. His works speak in respect to his erudition and deep understanding of the ensemble that goes into FDA compliance. That Dr. Huber is a notorious expert on not in some measure the FDA solely also added boss bodies is evident from the happening that he has been Chief Advisor on Global ISO 17025 and FDA Compliance. <\p>
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For whom:
This webinar will benefit
o IT Managers and Hue Administrators
o QA Managers and Employees
o QC and Lab Managers
o Validation Specialists
o Regulatory Affairs
o Training Departments
o Documentation Department
o Consultants
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Duration:75 minutes
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To enroll for this webinar, contact
[email protected]
Phone: 800-447-9407
ARTICLE URL <\p>
