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Compliance 360°

Set Alert for Compliance 360°

Compliance 360° Part 14: Leverage FDA Data To Stay In The Agency's Good Graces

This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this fourteenth installment, former FDA investigations branch director Ricki Chase explains how device-makers can leverage publicly available data from the agency to determine where they might fall short when it comes to complying with FDA rules and regulations.

Compliance 360 FDA Compliance

Compliance 360° Part 12: Navigating The Quicksand Of Device/Drug Combo Products (1 of 2)

This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this 12th installment – the first of two parts – former FDA investigations branch director Ricki Chase offers the latest insights into the complexity surrounding combination device/drug products. In this first podcast, Chase reviews regulations and guidance documents related to combo products, and highlights the varying types of combo products, definitions unique to device design, and how combo product manufacturers differ from the typical medical device or drug firm.

Compliance 360 Combination Products Compliance

Compliance 360° Playlist

Compliance 360° Part 13: Navigating The Quicksand Of Device/Drug Combo Products (2 of 2)

This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this 13th installment – the second of two parts – former FDA investigations branch director Ricki Chase brings you the latest insights into the complexity surrounding combination device/drug products. In this podcast, Chase digs deep into design control, design changes, human factors studies and biocompatibility concerns for combo products. She also discusses some pre- and post-market considerations, as well as common pitfalls to avoid.

Compliance 360 Combination Products

Compliance 360° Part 11: Turn Your CMO Nightmare Into A Dream Come True (2 of 2)

This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this 11th installment – the second of two parts – former FDA investigations branch director Ricki Chase discusses some of the more complex problems that may arise in the relationship between the owners of regulated products and contract manufacturing organizations (CMOs), and how to solve them.

Compliance Quality Control

Compliance 360° Part 10: Turn Your CMO Nightmare Into A Dream Come True (1 of 2)

This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this 10th installment – the first of two parts – former FDA investigations branch director Ricki Chase explains how owners of regulated products can learn "tricks" to managing their relationships with contract manufacturing organizations (CMOs) to avoid being "treated" to an FDA-483 inspection observation form.

Compliance Quality Control

Compliance 360° Part 9: US FDA Is Looking Closely At Process Validation – Are You Ready?

This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this ninth installment, we interview former FDA investigations branch director Ricki Chase, who explains why your device firm needs to be on the ball when it comes to process validation activities and offers tips for best practices.

Quality Control Compliance

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

This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this eighth installment, former 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

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

This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this seventh installment, former 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°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this sixth installment, former 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°, a 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°, a 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
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