# 117 - Post Market Surveillance, Safety Reporting, Databases, Platforms Health Hazards Assessments and Product Responsibilities with Khaudeja Bano

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-01-03
- Length: 34m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-03-117-post-market-surveillance-safety-reporting-databases-platforms-health-hazards
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/117---Post-Market-Surveillance--Safety-Reporting--Databases--Platforms-Health-Hazards-Assessments-and-Product-Responsibilities-with-Khaudeja-Bano-e2dts4c

## Summary

Khaudeja Bano, VP of Quality for Combination Products at Amgen, discusses post-market surveillance and safety reporting requirements for combination products under 21 CFR Part 4B. She explains the distinction between primary mode of action reporting (e.g., FAERS for drugs) and device-specific reporting, the importance of cross-functional teams in risk management, and strategies for handling platform-based products. Bano also details the complexities of international reporting timelines, such as 24-hour requirements in China, and the role of Health Hazard Evaluations in determining corrective actions.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-03-117-post-market-surveillance-safety-reporting-databases-platforms-health-hazards#t=0) Introduction and Part 4B Overview
- [2:29](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-03-117-post-market-surveillance-safety-reporting-databases-platforms-health-hazards#t=149) FDA Enforcement and Pharmacovigilance Infrastructure
- [9:11](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-03-117-post-market-surveillance-safety-reporting-databases-platforms-health-hazards#t=551) Reporting Databases and Field Actions
- [13:46](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-03-117-post-market-surveillance-safety-reporting-databases-platforms-health-hazards#t=826) Managing Product Responsibilities and Quality vs. Safety
- [21:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-03-117-post-market-surveillance-safety-reporting-databases-platforms-health-hazards#t=1260) Platform Risk Management and Health Hazard Assessments
- [28:06](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-03-117-post-market-surveillance-safety-reporting-databases-platforms-health-hazards#t=1686) International Reporting Requirements and Timelines

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

large enterprises

## Mentioned

- Amgen (company)
- AbbVie (company)
- Abbott (company)
- Guidant (company)
- FAERS (tool)
- VADER (tool)
- FDA (company)
- 21 CFR Part 4B (other)

## Related episodes from other shows

- [Understanding and Handling Different Types of Feedback](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-01-14-understanding-and-handling-different-types-of-feedback) (Global Medical Device Podcast)
- [#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment) (Global Medical Device Podcast)
- [#410: Is the MAUDE Database Broken? An Insider’s Take on Adverse Event Reporting Failures](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-06-09-410-is-the-maude-database-broken-an-insiders-take-on-adverse-event-reporting-fai) (Global Medical Device Podcast)
- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [#365: Medical Device Reporting: The Do's and Don'ts](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-07-365-medical-device-reporting-the-dos-and-donts) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-03-117-post-market-surveillance-safety-reporting-databases-platforms-health-hazards. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.