FDA-Regulated Environment Development Team 2017
WebcastFaculty
OVERVIEW
FDA-Regulated Environment Development Team is organized by Compliance4All and would be held on Jul 13, 2017.
Overview:
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:
• Countering the village rumors
• Understanding the REAL regulatory requirements
• Agile is a mindset, not a canned method
• Fitting together hardware and software development, and being Agile in both
• Applying Impact Mapping and Story Mapping practices to chart the way
• Bringing everyone on board, not just software
• Applying Agile to larger scale organizations / projects
• Metrics - how to use them and what to avoid
Why Should you attend:
Medical device development struggles with huge pressures: the need for innovation, keeping cost down, and minimizing time to market. With all its success in other industries, it appears that the Agile approach be a huge should help - but even after years of use and multiple reports, criticism of, and doubts about, Agile methods exist in the medical device field.
Areas Covered in the Session:
• Laying the Groundwork
• Recognize your context
• What Agile solves - and requires
• Selecting a project to pilot
• Change needs to be shepherded
Who Will Benefit:
• Regulatory Specialists
• Functional Managers - Software, Test, Hardware
• Other Development Specialists (mechanical, engineering, other)
• Project Managers (especially for cross-functional teams)
• Software Developers
• Business Analysts
• Requirements Analysts
• Product Managers
• Portfolio Managers
Speaker Profile:
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.
Additional details will be posted as soon as they are available.
Overview:
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:
• Countering the village rumors
• Understanding the REAL regulatory requirements
• Agile is a mindset, not a canned method
• Fitting together hardware and software development, and being Agile in both
• Applying Impact Mapping and Story Mapping practices to chart the way
• Bringing everyone on board, not just software
• Applying Agile to larger scale organizations / projects
• Metrics - how to use them and what to avoid
Why Should you attend:
Medical device development struggles with huge pressures: the need for innovation, keeping cost down, and minimizing time to market. With all its success in other industries, it appears that the Agile approach be a huge should help - but even after years of use and multiple reports, criticism of, and doubts about, Agile methods exist in the medical device field.
Areas Covered in the Session:
• Laying the Groundwork
• Recognize your context
• What Agile solves - and requires
• Selecting a project to pilot
• Change needs to be shepherded
Who Will Benefit:
• Regulatory Specialists
• Functional Managers - Software, Test, Hardware
• Other Development Specialists (mechanical, engineering, other)
• Project Managers (especially for cross-functional teams)
• Software Developers
• Business Analysts
• Requirements Analysts
• Product Managers
• Portfolio Managers
Speaker Profile:
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.
Additional details will be posted as soon as they are available.
SPECIALITIES
Healthcare TechnologyHealthcare ManagementRELATED ONLINE COURSES
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