FDA Quality System (QS) Software Validation Public Training Course DATES: June 2-4, 2020
COST: 3 Full Days for $2,595.00 (Registration closes 5/2/2020)
Volume Discount: $450 off for 4 or more students from same company
This course covers software validation expectations for the whole range of Quality System Software (QSS) including computer systems validation, production/manufacturing automation and control software, quality system process software, and engineering tools. As always, our approach is to show the flexibility of the regulations and help students understand the intent of the regulations to achieve validation methods that are efficient and effective … and how to correctly articulate alignment with regulations and standards. We emphasize the critical thinking concept and discuss foundational methods such as process risk analysis as a way to scale and focus the QSS software validation tasks and documentation.
- Regulatory landscape Software Validation Planning Off-the-shelf
- SOUP (open source, commercial)
- Legacy Software
- Intended Use / Requirements
- Process risk analysis
- Differing validation approaches based on risk
- Architecture and detailed design
- Implementation, Coding, Unit verification
- Integration and integration testing
- Problem Issue and Defect Management
- Usability Evaluations
- Configuration Management
- Development process rigor
- Maintenance phase (Change control, Retirement)
- Document Hierarchies and Traceability
- Electronic records & Signatures / 21 CFR Part 11 Cybersecurity
This 3 day course will be taught by Brian Pate of SoftwareCPR and John F. Murray, Jr.
Full credentials on our website: https://www.softwarecpr.com
Who Should Attend this FDA QS Software Validation Training Course?
Quality Assurance and Regulatory Affairs professionals. This course will provide a clear understanding of requirements versus areas of flexibility and provide checklists and questions to use for gap analysis, auditing, and vendor and OEM qualification and management.
Manufacturing, IT Managers and staff, Production/process and control, Product Owners, Scrum Masters/Coaches, software development managers/engineers, and test engineers. This course provides examples, checklists, and partial templates as well as improving articulation and defense of your approaches to regulatory bodies, internal quality assurance, and regulatory affairs departments.
Training Course Location
Training will be held on the 18th Floor of the “10 Buick St” building on the campus of Boston University in Boston, MA USA. There are nearby hotels within walking distance or you might consider BU Housing (contact them directly http://www.bu.edu/housing/).
Course start 9:00 am ET each day and ends at 5:00 pm PT. Lunch is provided. Course will end by 4:00 pm ET on 3rd day.
Would you (or one of your colleagues) like to know more about the course? You can get more information on our courses at this link: https://www.softwarecpr.com/training/
Are there opportunities for discounts? Yes! We have a special $450 per person discount when you register 4 or more students from the same company. Other discounts may be available … please email firstname.lastname@example.org to learn more.
If you prefer to be invoiced for the registration, please email email@example.com and we will get the registration information and other info needed.