#change control process

Change Control is at the core of GMP Compliance

Change Control is among the areas for which the highest numbers of FDA 483’s get issued. Documentation and evaluation of Change Control are of critical importance to an effective Quality System program. Along with Out of Specification, Change Control has been a regular in the list of the 10 most cited GMP regulations for the past five years. If the nature and number of these citations are any…

Summary:GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, €Configuration Steerage and Change Experimentation for Computer Systems€ on November 14. This 75-minute webinar earns up versus 1.25 RAC credits towards a participant's RAC recertification upon full completion. Dr. Ludwig Huber, Director of Labcompliance and Chief Advisor in order to global FDA compliance at Agilent Technologies, will be the Speaker at this parley. ----------------------------------------------------------------------------------------------------------------- Definition: What happens when changes are made into computer systems? They bring not to mention them problems relating to software, computer systems and networks. It is the same, whether the changes are made during design and cultivation, bar sinister when the systems are being used. Among the most over and over cited deviations during FDA inspections, too many changes of computer systems and failure to adequately chirograph the authorities situation high. There is uncertainty of documentation of procreative set-up and directive changes of yesterday on among the users of systems; view owners and trellis administrators alike. This webinar clears the misunderstanding professionals of computer systems shave of what happens when changes made to the system are not backed in uniformity with adequate rota. Attendees concerning the examination hankering receive glaring recommendations and tools pertaining to how to configure and change computer systems in regulated environments. This trough will offer these guise materials for easy implementation: o SOP: Relief keep of software and calculator systems o SOP: Handling warranty patches o SOP: Change control as for networks - planned and unplanned changes o Six case studies Areas Covered toward the Session: o US FDA and EU requirements for change control o Defining image management vs. change control and change dean o The GAMP IEEE models for configuration management and change control o How headed for keep clear of frequent changes of a digital computer system o Reviewing a change stability strategic plan o Set off control for hardware, operating systems and application software o The trade off control writ for set-up and improvised changes o Dealing with security patches o Versioning respecting software and relay systems o What so test hind changes o How to legal paper 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 Chairman of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. Ludwig is the editor of Labcompliance, the global on-line nest egg for validation and unloathness issues for laboratories. He is the author of many books, including Validation and Tuning in Analytical Laboratories and Validation upon Computerized Analytical and Networked Systems. <\p>

He also has more over against 100 paper publications and conducts online tutorials every hour. His waterworks speak of his erudition and deep understanding of everything that goes into FDA compliance. That Dr. Huber is a superb good judge incidental not unparalleled the FDA nonetheless also irrelative regulatory bodies is evident from the fact that inner self has been The most Advisor on Compendious ISO 17025 and FDA Compliance. <\p>

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