Summary:GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, “Configuration Management and Change Control for Computer Systems” on November 14. This 75-minute webinar earns up to 1.25 RAC credits towards a participant's RAC recertification upon full completion. Dr. Ludwig Huber, Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies, will be the Speaker at this session. ----------------------------------------------------------------------------------------------------------------- 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: o SOP: Change control of software and computer systems o SOP: Handling security patches o SOP: Change control of networks - planned and unplanned changes o Six case studies Areas Covered in the Session: o US FDA and EU requirements for change control o Defining configuration management vs. change control and change management o The GAMP IEEE models for configuration management and change control o How to avoid frequent changes of a computer system o Reviewing a change control procedure o Change control for hardware, operating systems and application software o The change control process for planned and unplanned changes o Dealing with security patches o Versioning of software and computer systems o What to test after changes o How to document changes o Going through examples for hardware, software and networked systems ----------------------------------------------------------------------------------------------------------------- When:November 14, 10:00 AM PDT 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- 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. ----------------------------------------------------------------------------------------------------------------- For whom: This webinar will benefit o IT Managers and System Administrators o QA Managers and Personnel o QC and Lab Managers o Validation Specialists o Regulatory Affairs o Training Departments o Documentation Department o Consultants ---------------------------------------------------------------------------------------------------------------- Duration:75 minutes ----------------------------------------------------------------------------------------------------------------- To enroll for this webinar, contact webinars@globalcompliancepanel.com Phone: 800-447-9407 AMAZINES.COM
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