Device Software Verification and Validation

Webinar Details

whenWhen?  Tuesday, Aug. 12, 2014
whereWhere? Your Office
whenTime? Anytime

Register

Webinar plus Audio CD/Transcript $487
Webinar only $287

 

Device Software Verification and Validation

The FDA is focusing on medical device software verification and validation.  What can you do to prepare?

Mark your calendar for Tuesday, Aug. 12, for On-Demand access to John Lincoln’s immensely popular webinar on software verification and validation.

Here’s what our satisfied registrants had to say on what they liked about this webinar:

  • “Good examples of what the presenter has done successfully.”
  • “Lots of detail and suggestions. Clear speaker, clear slides.”

The software associated with medical devices is under 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.

Mark your calendar for Aug. 12, when veteran FDA consultant John Lincoln explains what the FDA expects of you now, and how to achieve it in a hurry.

In a 90-minute, in-depth chalk talk, Mr. Lincoln 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.

He addresses use of FDA guidances, 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.

You’ll come away with an actionable understanding of:

  • 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 the FDA’s expectations 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:
    1. Level of Concern
    2. Hazard/Risk Analysis
    3. Software Description
    4. SRS (Software Requirements Specification)
    5. Architecture
    6. Design Specification
    7. Traceability (Matrix; Paragraph Numbering)
    8. Development
    9. V&V (Verification/Testing & Validation: IQ, OQ, Part 11 test cases, if required, PQs)
    10. Revision History and Release Number
    11. Unresolved Anomalies ('Bugs')
  • “White Box” and “Black Box” validations
  • And much more

Software design and validation cuts across department lines. You’ll want to make sure senior executives participate from both the quality and manufacturing sides, including software development, programming, documentation, testing, QA/RA, R&D, engineering, production and operations. Fortunately, there’s just one low registration fee per participating facility, so go ahead — put out a companywide memo and book a big room right now.

Device Software Verification and Validation will give you a clear understanding of FDA expectations and how to meet them, with a specific focus on software that is as-product, in-product, process and/or in overall manufacturing and operations. Why risk FDA sanctions, let alone multimillion-dollar liability lawsuits?

Please note; this webinar has been previously recorded and no questions will be taken during the presentation. You may listen to the recording at your convenience on Aug. 12.