Hardware Podcasts

#358: FDAs Voluntary Improvement Program

Global Medical Device Podcast · 21 Mar 2024 · 28m · Episode 358

What this episode covers

Kim Kaplan from ISACA explains the FDA’s Voluntary Improvement Program (VIP), which uses the CMMI framework to help medical device companies move beyond basic compliance toward operational excellence. She details how the program identifies gaps in project management and data measurement, offering participants regulatory benefits like waived inspections and faster change notice approvals. Kaplan emphasizes that VIP is designed for organizations that are already compliant and seeking continuous improvement, rather than startups needing initial FDA registration.

Most relevant to

established companies

Topics

Mentioned

Companies
Green Light Guru, MDIC, Deloitte, FDA
Tools
CMMI

Related episodes from other shows

Other shows on the same ground, closest first.

  • Let's Combinate · 9m

    256 - The New FDA Inspection Playbook: Where to Start with QMSR

    Subhi Saadeh, founder of Let’s Combinate, introduces a four-part series on FDA inspection readiness under the new Quality Management System Regulation (QMSR), explaining how the retired QSIT framework has been replaced by Compliance Program 7382.850. He highlights advice from former FDA investigator Eric Pittman, who advises industry to focus exclusively on Section III of compliance programs as the primary roadmap for inspections. The episode details the shift from QSIT’s four major subsystems to six QMS areas, emphasizing a risk-based approach where investigators evaluate product risks and control effectiveness.

    Certification & compliance
    3 chapters

  • Let's Combinate · 45m

    253 - FDA Is Making Big Changes to Its Inspection Approach

    Eric Pittman, former Bioresearch Monitoring West Division Director at the FDA and now VP at Project Farma, explains the FDA's transition from a specialized program-aligned inspection model back to a broader, medical-product-specific generalist model under the new Office of Investigations and Inspections (OII). He details the operational differences between routine inspections under Section 704 and undercover investigations under Section 702, emphasizing that investigators prioritize human subject safety over minor regulatory technicalities. Pittman advises industry to focus on the FDA’s Investigations Operations Manual (IOM) and specific compliance programs rather than cosmetic facility improvements, noting that the end of QSIT has shifted focus to broader process evaluation.

    Certification & complianceQuality & yield
    11 chapters

  • Let's Combinate · 52m

    128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture

    Vin Cafiso, former FDA Consumer Safety Officer and Managing Consultant at Practical Compliance Results, discusses the transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) and its impact on small medical device companies. He explains how FDA inspection methodologies are shifting from issue-focused 483s to process-based QSET audits, emphasizing the importance of understanding quality culture through simple engagement rather than rigid metrics. Cafiso shares insights from his career at companies like BD and Smith & Nephew, highlighting how starting as an investigator builds a strong foundation for industry roles by providing a broad view of quality systems across diverse products and company sizes.

    Certification & complianceLeadership, teams & culture
    6 chapters

  • Let's Combinate · 1h 12m

    024 - "Operating Under Constraints "with Naveen Agarwal

    Naveen Agarwal, a PhD polymer scientist and quality management consultant at Creative Analytics Solutions, discusses operating under constraints, drawing parallels between his 1,500-mile running challenge and risk management in medical devices. He explains the distinction between post-market vigilance and surveillance, advocating for a customer-experience-focused approach to quality improvement that goes beyond regulatory compliance. Agarwal introduces the SNIP framework (Strength, New, Importance, Preventable) for data-based decision-making in post-market surveillance and argues that safety performance should drive innovation and reimbursement rather than just meeting baseline safety standards.

    Quality & yieldCertification & compliance
    9 chapters

  • Let's Combinate · 25m

    155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach

    Laurie Auerbach, President of Compliance Prodigies, LLC, explains FDA Compliance Program 7356.000, clarifying that contract manufacturers (CMOs) and component suppliers selling bundled solutions are legally defined as combination product manufacturers. She highlights common failures in mock Pre-Approval Inspections (PAIs), particularly the misconception that drug GMPs (21 CFR 211) and ICH Q10 fully satisfy device requirements under 21 CFR Part 4. Auerbach emphasizes that sponsors often fail to audit suppliers for device-specific elements like design control, risk management, and specific supplier controls, leading to critical gaps in quality agreements and inspection readiness.

    Certification & complianceManufacturing partners & offshoring
    6 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Global Medical Device Podcast. The episode itself belongs to its publisher.