Speaker Profile


Brian Shoemaker

CO-CHAIRMAN, ShoeBar Associates

Brian Shoemaker consults for healthcare products companies on computer system validation, software quality assurance, and electronic records and signatures. He has conducted validation both on product software and on internal software, developed software quality systems, audited software quality processes (including agile methodology), and evaluated 21 CFR Part 11 compliance. He has had clients in clinical diagnostics, medical device engineering, medical imaging, medical-device fabrics manufacturing, contract lyophilization, clinical trial software, dental prosthetics, and bone-repair implants. He has worked with companies in Germany and Switzerland as well as the U.S.

Previous to founding ShoeBar Associates, Brian had quality roles at PPD Informatics, Doxis, Inc., and Behring Diagnostics, Inc. Brian earned his Ph.D. in chemistry from the University of Illinois; he has achieved the ASQ Software Quality Engineer certification.

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  • Recorded
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  • 90 Minutes
  • ¤190.00
Implementing Agile in an FDA-Regulated Environment

The Agile approach is well established in other industries adoption of Agile in medical device development has been increasing in the past five years. Experience is showing that both quality and safety are improved when the development team is agile, and that regulatory requirements can still be met. This session will delve into several key areas for applying Agile in the medical device context, including:

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤190.00
Agile for Medical Devices: More than Just Software

Trying to understand the "Agile method" as just another software development lifecycle, with specific rules and a fixed outline, is mistaken, and seriously limits the benefits that Agile can bring. Successful Agile implementations include development, operations and business functions right from the outset. Anything less just creates another process island and cross function friction. All functions must participate actively throughout development, since development is recognized to require learning and adapting (and market needs can change rapidly).

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤190.00
Standards for Medical Device Software: Friend, not Foe

With various changes to standards and regulations, it is important to understand the criteria for compliance, this is your DIY guide to the changes in standards, specifically covering the IEC 62304 standard.

  • Recorded
  • View Anytime
  • 90 Minutes
  • ¤390.00
Implementing Agile in an FDA-Regulated Environment

The Agile approach is well established in other industries adoption of Agile in medical device development has been increasing in the past five years. Experience is showing that both quality and safety are improved when the development team is agile, and that regulatory requirements can still be met. This session will delve into several key areas for applying Agile in the medical device context, including:

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