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Making Agile Work in Highly Regulated Environments

Online Event

Highly regulated industries—avionics suppliers, medical device companies, and pharmaceutical manufacturers—must meet rigorous quality standards to ensure their products are not a danger to the general public. Although compliance has traditionally been achieved with heavyweight waterfall or V-model development methodologies, you can implement agile—or lean-agile—development practices that adhere to standards-based regulations while reducing the risk and improving software quality and reliability.

In this Webinar, Colin Doyle will identify the constraints that agile and lean-agile software development approaches must address: traceability to clearly defined requirements, formal risk analysis and mitigation, and separation of roles between development and validation. Colin describes ways to leverage agile practices within regulatory constraints, offering specific examples from the commercial avionics standard DO-178B and FDA CDRH software validation guidelines. Take back specific recommendations for implementing agile and lean-agile practices that work within formal standards and demonstrate to regulatory agencies or auditors that appropriate processes are defined and followed.


* On October 19, at least 10 minutes prior to the start time of 2:00 PM EDT, direct your browser to: https://mks.webex.com/mks/onstage/g.php?d=351107636&t=a
* Enter your name, email address and the password. The password is abd123.


The audio for this event will be streaming. Please ensure you have a working headset or speakers for your computer available.


Please contact Julie Vaishnav at jvaishnav@mks.com.

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