Objectives
At the end of this workshop, participants will be able to:
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Understand the purpose, benefits, and objectives of FDA’s Medical Device Quality System Regulation (QSR).
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Analyze the meaning of the elements of the QSR.
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Compare the relationship between standards and guidance documents in support of FDA compliance initiatives.
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Understand international harmonization efforts and their effects.
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Learn how to read FDA warning letters and recognize situations that warrant warning for QSR deficiencies.
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Map the requirements of the QSR versus your system and establish audit evidence to support FDA compliance.
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Know when ISO 13485 compliance is required.
Topics
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The Quality System Regulation (QSR) – an integral aspect of the management system
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QSR background
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QSR subpart reviews
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Recent FDA inspectional observations
Who Should Attend
Designed for those who need to understand and apply the requirements of the QSR, including R&D managers; engineering managers; management representatives; product, project, and program managers; RA/QA managers/engineers; internal auditors; and other cross-functional team members.
Number of Days:
2
CEUs:
1.5