Software Verification & Validation
In this 90 minutes session, Lena Cordie demonstrates a preferred FDA 11-element documentation model in various applications; including ERP, in-device, as-device, process/equipment control and cGMP data/Part 11 applications.
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Software problems are now the third-leading cause for recalls of medical devices. Most recalls are because of incorrect verification and validation for safety. Most of the knowledge on how to do a comprehensive V&V is not widely understood.
You'll come away with an actionable understanding of:
Why should you Attend:
- Developing and creating buy-in for a project validation plan
- Understanding what the FDA accepts as an appropriate documentation model
- Beyond just in-product software V&V - understanding FDA's expectation for your testing software, ERP software and more
- When and how to use DQ, IQ, OQ, PQ or their equivalents
- How GAMP 4/5 requirements fit into your V&V planning and execution
- Detailing the FDA's 11 key V&V documentation elements:
- Level of concern
- Hazard/Risk analysis
- Software description
- SRS (Software Requirements Specification)
- Design specification
- Traceability (Matrix; Paragraph Numbering)
- V&V (Verification/Testing & Validation: IQ, OQ, Part 11 test cases, if required, PQs)
- Revision history and release number
- Unresolved anomalies ('Bugs')
Software design is a complex set of interactions within the device, with the connecting devices, and with users of the device. Usually multiple factors affect the device performance. Therefore right validation is the key to prevent device recalls. The software associated with medical devices is getting closer scrutiny than ever before because of increasing prevalence in industry, greater chance for problems, and the comfort level of FDA investigators in asking for and auditing software applications.
In a 90-minute in-depth program, Lena Cordie demonstrates a preferred FDA 11-element documentation model in various applications; including ERP, in-device, as-device, process/equipment control and cGMP data/Part 11 applications. She addresses the use of FDA guidance's, GAMP 4/5, 21 CFR 11, and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Risk Management models and their real-world implementation.
Areas Covered in the Session:
Who Will Benefit:
- FDA Quality System Requirements for software
- FDA guidelines on software verification and validation
- Smart software verification methods
- How to design smart validation tests
- How to conduct black box testing and white box testing to perform thorough validation
- Software Developers and Managers
- Internal Auditors
- Quality Assurance Personnel and Management
- Software Quality Personnel
- Software Test Personnel
- Regulatory Affairs Personnel and Management
- IT Managers and System Administrators
- Software Validation Engineers
Lena Cordie has over 20 years of quality and project management experience including:
10 years in project management at Target Financial Services.
11 years as Director of Operations at Key Surgical, a medical device company focused on sterile processing, personal protection, and OR products. In this position she was responsible for overseeing all quality and regulatory functions, production, product procurement, and order fulfillment.
As a consultant at Qualitas Professional Services, LLC, Ms. Cordie now focuses on helping companies implement quality management systems, UDI solutions for labelling and FDA GUDID submissions, and providing validation, documentation and project management resources to global medical device companies.
She is an active member of:
AAMI (Association for the Advancement of Medical Instrumentation) - serves as a voting member of many sterilization standards committees and co-chairs the terminology committee.
ISO (International Organization for Standardization) - serves as a US representative and participates in ISO/TC 198 (ISO 17664 & ISO 11139) and ISO/TC 210 (ISO 13485 & ISO 15223) working groups.
RAPS (Regulatory Affairs Professionals Society) - serving as chairperson of the RAPS Twin Cities Chapter and a member of the RAPS EU Committee.
AHRMM Learning UDI Community.