What You Will Learn
At the conclusion of this workshop, you will be able to:
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Identify design control regulatory requirements and standards.
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Describe a process model for design and development.
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Describe the role of usability and human factors in the design control process.
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Evaluate the links between design, usability, and risk management.
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Describe design review, design verification, and design validation processes.
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Identify strategies for risk-based sampling and statistical justification.
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Describe best practices for the design transfer process.
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Practice the design control process in workshops, building a design history file (DHF).
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Describe postmarket surveillance and input to design changes.
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Identify FDA inspection techniques (QSIT) related to design controls.
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Identify MDSAP (Medical Device Single Audit Program) outcomes and linkages related to design and development process.
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Identify best practices in preparing for inspections and audits
Who Should Attend
Anyone managing, developing, or engaging in the design of medical devices, including direct engineering functions, QA/QC, production management, and regulatory, as well as anyone else who has a role in building a robust regulatory-compliant environment. Attendees must have a basic familiarity with FDA 21 CFR Part 820 and ISO 13485.
Virtual Class Days
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5 consecutive half-day sessions.
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Daily sessions run from 1:00-5:00 p.m. Eastern Time
Virtual Half-Days:
5
In-Person Full-Days:
3
CEUs:
2.5