035 - “Safety is Safety” with Khaudeja Bano

On this episode, I was joined by Dr. Khaudeja Bano, Vice President of Combination Product Quality at Amgen. On this episode Khaudeja and I discuss:

- Safety function (Drug vs. Device)

- 21 CFR Part 4 Subpart B 

- Specific Post-Market Safety Reporting Expectations

- Industry Challenges with implementing PMSR Requirements

- Working in Quality with a background in Safety

- Self Marketing, Toastmasters and Professional Development

Dr. Khaudeja Bano is the VP of Combination Products Quality at Amgen. Executive director of combination product safety. She's held multiple roles at other companies  as well like Abbvie, Abbott, and Guidant and is the chair of the Post Market Safety committee for the combination products coalition.