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Compliance 360°

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Compliance 360° Part 8: Patient Influence On US FDA’s Enforcement Strategy

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this eighth and final installment, former US FDA investigations branch director Ricki Chase explains how the role of the patient influences FDA's enforcement strategy and discusses the agency's recent industry guidance on benefit-risk factors.

Quality Control Compliance Quality

Compliance 360° Part 7: Factors Feeding Your Inspection Cycle – A New Paradigm

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this seventh installment, former US FDA investigations branch director Ricki Chase explains how new initiatives within the agency and center for devices – including FDA's in-the-works "program alignment" inspection initiative, may affect your facility audits. Also discussed: the Medical Device Single Audit Program (MDSAP), the joint FDA/Medical Device Innovation Consortium (MDIC) Case for Quality, and FDA's Voluntary Compliance Improvement Program (VCIP).

Quality Control Compliance

Compliance 360° Part 6: Don’t Do That! How To Respond To FDA-483s

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this sixth installment, former US FDA investigations branch director Ricki Chase explains how your firm can best respond to the agency following the issuance of an FDA-483 inspection form, and tells you four things your firm should never do when replying to FDA.

Quality Control Compliance

Compliance 360° Part 5: Medical Device 483s – US FDA's Top 5 Observations

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this fifth installment, former FDA investigations branch director Ricki Chase highlights the agency's top 5 inspection observations found on FDA-483 inspection forms, including failing to have procedures for corrective and preventive action (CAPA), complaint handling, purchasing controls, process validation, and nonconforming product.

Quality Control Compliance

Compliance 360° Part 4: How To Better Manage Your Quality Data

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this fourth installment, former FDA investigations branch director Ricki Chase explains how your firm can better manage its quality data.

Quality Control Compliance

Compliance 360° Part 3: Building Trust With US FDA – Can It Be Done?

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this third installment, former FDA investigations branch director Ricki Chase explains how your firm can build trust with agency investigators during a facility inspection.

Quality Control Compliance

Compliance 360° Part 2: Getting The Most Out Of Inspection Close-Out Meetings

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this second installment, former FDA investigations branch director Ricki Chase explains steps your firm should take to make sure inspection close-out meetings are fruitful for everyone involved.

Quality Control Compliance

Compliance 360° Part 1: Handling Difficult US FDA Investigators

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this first installment, former FDA investigations branch director Ricki Chase explains how you should handle a difficult agency investigator who shows up at your facility door.

Quality Control Compliance
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