This Computer Systems training/webinar will provide strategies and tools for FDA compliance change and version control of planned and unplanned changes. Attendees will receive reference documents for easy implementation.
It is well known that most problems of software, computer systems and networks are introduced when changes are made, either during development or during use of the systems. Inadequate documentation of changes and testing after changes is one of the most frequently cited deviations during FDA inspections. Users of the system, system owners and network administrators are unsure on how to document initial set-up and manage changes. This seminar will provide strategies and tools for FDA compliance change and version control of planned and unplanned changes. Attendees will receive reference documents for easy implementation.
Areas Covered in the seminar:
- US FDA and EU requirements for change control
- Difference between configuration management vs. change control and change management
- The IEEE model for configuration management and change control
- Change control for hardware, operating systems and application software
- The change control process for planned and unplanned changes
- Versioning of software and computer systems
- How to deal with security patches
- What to test after changes
- How to document changes
- Learning through case studies:
- computer hardware, firmware
- software (operating system, applications, security patches)
- networks (server, client, router)
- documentation (specifications)
Who Will Benefit:
- Everybody involved in software and computer system validation
- IT managers and administrators
- QA managers and personnel
- Validation specialists
- Suppliers of software and computer systems
- Documentation department
- Regulatory affairs
- Training department
- Consultants
Additional benefits:
- Attendees will receive the presenter’s SOPs for Change Control and Version Control of software and computer systems and also a set of 6 case studies for planned and unplanned changes.
Instructor Profile:
Ludwig Huber, Ph.D., is Compliance Program Manager at Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resources for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press. For more information, visit Dr. Huber’s website: www.ludwig-huber.com
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