Hardware Podcasts

Preparing for Remote and On-Site Inspections and Audits

Global Medical Device Podcast · 24 Feb 2021 · 50m · Episode 182

What this episode covers

Steven Niedelman and Eric Henry from King & Spalding’s FDA and Life Sciences practice discuss strategies for medical device companies to prepare for FDA inspections and audits, particularly in the context of resumed on-site and remote inspections. They emphasize the importance of systemic corrective actions for CAPA issues, preparing for pre-market and for-cause inspections, and conducting thorough mock audits to ensure staff readiness. The guests also advise firms that received QMS exemptions under Section 564A to begin remediation toward compliance with 21 CFR 820 and ISO 13485.

Most relevant to

established companies

Topics

Mentioned

Companies
King & Spalding, Green Light Guru
Also
FDA, MDSAP, ISO 13485, 21 CFR 820

Related episodes from other shows

Other shows on the same ground, closest first.

  • 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

  • Let's Combinate · 25m

    219 - FDA PreCheck and the Future of Inspections: PAI to Pre-Readiness

    Host Subhi Saadeh and guest Ben Locwin discuss the FDA's evolving approach to Pre-Approval Inspections (PAIs) and Pre-License Inspections (PLIs), focusing on the industry's push to decouple inspection timing from approval decisions to avoid Complete Response Letters (CRLs). They analyze the FDA's new PreCheck program, designed to accelerate the regulatory review of onshored pharmaceutical manufacturing facilities, and compare US regulatory strategies with those of the EMA and MHRA.

    Certification & compliancePolicy, trade & tariffs
    6 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 · 34m

    201 - Inside a $300M FDA Remediation, Lessons from Zimmer to EpiPen Warning Letters, 99.999% Reliability and Quality 4.0

    Jeff Gensler, a veteran quality executive, details his experience leading massive FDA remediation efforts at Zimmer Biomet and Pfizer’s Meridian Medical Technologies. He explains how his team managed a $300M remediation of 1,400 Design History Files (DHFs) at Zimmer and achieved 99.999% reliability for the EpiPen through rigorous CAPA processes and FDA negotiations. Gensler also discusses his transition to Kindeva Drug Delivery, where he oversaw a state-of-the-art facility buildout, and his current work founding the Quality 4.0 Consortium to help small and mid-sized pharma companies adopt digital quality systems like Electronic Batch Records (EBRs) and AI.

    Quality & yieldCertification & compliance
    6 chapters

  • 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

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.