Source: https://medtech.pharmaintelligence.informa.com/mti-originals/compliance-360
Timestamp: 2018-09-25 15:38:18
Document Index: 40779170

Matched Legal Cases: ['art 12', 'art 13', 'art 11', 'art 10', 'art 9', 'art 8', 'art 6', 'art 4', 'art 3']

Compliance 360° :: Medtech Insight
Set Alert for Compliance 360°
A podcast series on US FDA compliance and enforcement issues.
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° 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° Playlist
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 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.
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.
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).
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.
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.
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.
Compliance 360° Part 3: Building Trust With US FDA – Can It Be Done?
This is Compliance 360°, a 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.
Subject: Compliance 360°