Hardware Podcasts

035 - “Safety is Safety” with Khaudeja Bano

Let's Combinate · 1 Jun 2022 · 47m

What this episode covers

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.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Amgen, AbbVie, Abbott, Guidant
Products
auto-injectors, prefilled syringes, on-body injectors, heparin
Also
Combination Product Coalition, 21 CFR Part 4 Subpart B, Toastmasters

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