Hardware Podcasts

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

Let's Combinate · 3 Jan 2024 · 34m

What this episode covers

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.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Amgen, AbbVie, Abbott, Guidant, FDA
Tools
FAERS, VADER
Also
21 CFR Part 4B

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