# 035 - “Safety is Safety” with Khaudeja Bano

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-06-01
- Length: 47m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-01-035-safety-is-safety-with-khaudeja-bano
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/035---Safety-is-Safety-with-Khaudeja-Bano-e1jb598

## Summary

Dr. Khaudeja Bano, Vice President of Combination Product Quality at Amgen, explains the regulatory and cultural challenges of implementing 21 CFR Part 4 Subpart B for combination products like auto-injectors and prefilled syringes. She details the specific post-market safety reporting (PMSR) requirements, including 15-day and 30-day timelines, and how manufacturers must integrate drug and device safety data. Bano discusses the industry's struggle with mindset shifts, moving from treating device components as simple container closures to embracing design controls and cross-functional collaboration to ensure patient-centric safety.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-01-035-safety-is-safety-with-khaudeja-bano#t=0) Introduction: Dr. Khaudeja Bano and Amgen
- [4:22](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-01-035-safety-is-safety-with-khaudeja-bano#t=262) Drug vs. Device Safety Philosophies: Gray vs. Black/White
- [13:51](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-01-035-safety-is-safety-with-khaudeja-bano#t=831) Pharmacovigilance and Cluster Events in Combination Products
- [19:05](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-01-035-safety-is-safety-with-khaudeja-bano#t=1145) 21 CFR Part 4 Subpart B and E-to-B Reporting Requirements
- [29:26](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-01-035-safety-is-safety-with-khaudeja-bano#t=1766) Industry Challenges: Culture, Mindset, and Quality Integration
- [35:50](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-01-035-safety-is-safety-with-khaudeja-bano#t=2150) Transitioning from Safety to Quality Leadership
- [40:20](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-01-035-safety-is-safety-with-khaudeja-bano#t=2420) Professional Development: Toastmasters and Compassionate Leadership

## Topics

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

## Most relevant to

large enterprises

## Mentioned

- Amgen (company)
- AbbVie (company)
- Abbott (company)
- Guidant (company)
- Combination Product Coalition (other)
- 21 CFR Part 4 Subpart B (other)
- auto-injectors (product)
- prefilled syringes (product)
- on-body injectors (product)
- heparin (product)
- Toastmasters (other)

## Related episodes from other shows

- [#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)
- [#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)
- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (Global Medical Device Podcast)
- [#342: Planning an FDA Submission](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-02-342-planning-an-fda-submission) (Global Medical Device Podcast)
- [What are the Top Compliance Issues Plaguing Medical Device Manufacturers?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-10-what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers) (Global Medical Device Podcast)

## Citing this page

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