Tue, June 02 2020, 9:00 AM - Thu, June 04 2020, 5:00 PM [EST]
10 Buick Street, Boston, MA, 02215, United States
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. 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 you know, our approach is never a one-size-fits-all approach, but we help our clients 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 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), and Legacy Software Intended Use / Requirements Process risk analysis Architecture and detailed design Implementation, coding, unit verification Integration and integration testing Problem Issue and Defect Management Usability Release, Configuration Management Development process rigor Maintenance phase (Change control, Retirement) Document Hierarchies and Traceability / Electronic records 21 CFR Part 11 Cybersecurity For each training module, we discuss examples of methods and documentation, tips, pitfalls, and best practices. SoftwareCPR also provides a 3-day public and private FDA/62304 Training course for product software in medical device and HealthIT. More info at https://www.softwarecpr.com/training/
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.
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 you know, our approach is never a one-size-fits-all approach, but we help our clients 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 methods such as process risk analysis as a way to scale and focus the QSS software validation tasks and documentation.
For each training module, we discuss examples of methods and documentation, tips, pitfalls, and best practices.
SoftwareCPR® provides full service regulatory compliance and premarket submissions support for Medical Device Manufacturers including quality systems development, risk management - including for Health IT and Standalone Software, Human Factors and usability engineering, as well as hands-on validation services for Pharmaceutical and Medical Device companies. We also have extensive experience related to FDA enforcement action representation and negotiation and have served as expert witnesses.
Brian was a medical device software engineer and product designer for over 20 years and has now been a partner with SoftwareCPR® for 14 years. He is the lead instructor for the AAMI/FDA course on Software Regulation and has taught the course at FDA to FDA Reviewers and other staff. Brian served on the TIR working groups that created the AAMI TIR45 Effective Use of Agile Methods and TIR32 (IEC 80002-1) Software Risk Management. Brian is also a member of the UL Standards Technical Panel 5500, Remote Software Updates.
John is a 25 year FDA veteran. John served as a regulatory and compliance expert for FDA regulated computers and software. Practice (focus) areas include FDA software related guidances, software device classification determination, pre-market software review, post market software inspectional 483’s, additional information software requests, Digital Health Pre-certification, AAMI Software related TIRs and related medical device software standards.
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