Let's Combinate - Drugs + Devices2 Helmi 2022

018 - "The Optimist Plans for Forever" - with Sarfaraz Niazi

On this episode of the podcast, we had Professor Sarfaraz Niazi, a "Renaissance Man" if I ever met one. We discuss what biosimilars are and how they differ from generics, how he predicted biologics and biosimilars would be the future of medicine, his inventions starting from coffee mugs and hats to bioreactors that don't have an exhaust, how he passed the federal bar exam without attending law school, how he writes 4 to 5 books a year(with more than 50 books published), passions vs. hobbies, how he schedules his day and more.

Prof. Sarfaraz K. Niazi, Ph.D., SI, FRSB, FPAMS, FACB, founder of Pharmaceutical Scientist Inc. and Adello Biologics (acquired by Kashiv Biosciences), is an adjunct professor at the University of Illinois. A prolific inventor with scores of patents in a variety of fields to his name, Sarfaraz has developed the MayaBio® bioprocessing platform that allows faster development and manufacturing of biological products at the lowest cost. Sarfaraz has published extensively including consumer articles and books, refereed scientific research, technical handbooks, poetry translations, philosophic rhetoric, and technical textbooks that are required reading worldwide. He has written most books in the field of bioprocess engineering and biosimilars. His honors include the prestigious University of Illinois Alumnus of the Year Award, Inductee into Chicago Entrepreneurs Hall of Fame, the Star of Distinction—the high civil award from Pakistan; Forbes magazine has called him, “The Most Interesting Man Revolutionizing the Health World.”

https://www.niazi.com/expertise

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250 - PIC/S PI 006-4 (2026): What Changed in Qualification & Validation?

PIC/S has issued its first major update to its qualification and validation recommendations in nearly 20 years. PI 006-4 replaces PI 006-3 from 2007 and brings the document much closer to how qualific...

12 Elo 11min

249 - The Best Audit Advice Nobody Told Me

Audits are not supposed to be gotchas, and they are not meant to evaluate one person’s work in isolation. A good audit looks at whether a system is suitable, effective, and adequate and where it may n...

5 Elo 14min

248 - What Is a Quality Unit? QA vs. QC Explained

What is a Quality Unit and how do Quality Assurance and Quality Control fit within it?In this episode, I explain the practical differences between the Quality Unit, QA, and QC across pharmaceutical, m...

29 Heinä 8min

247 - Why Everyone in Pharma and MedTech Should Work in Quality

Quality is often treated like a necessary function rather than an exciting career path. But working in quality can give professionals in pharma, biotech, and MedTech a much broader understanding of ho...

22 Heinä 8min

246 - The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)

Most discussions about One QMS focus on harmonization.But before deciding whether a single global Quality Management System is the right approach, it's worth understanding the three primary ways organ...

15 Heinä 8min

245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector

In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh talks with Julia Anthony, founder and chief strategy officer of Solution Medical, about adrenal crisis, emergency hydrocortisone, and ...

8 Heinä 45min

244 - 5 Critical Quality Differences Between Drugs and Devices

Download the free Drug vs. Device Quality comparison guide here: https://letscombinate.kit.com/216fbfc6c2In this Let’s Combinate episode, Subhi explains why drug and device quality are not the same an...

1 Heinä 8min

243 - Why Kitting A Finished Medical Device with a Drug Create So Much Work

Chat with Subhi: https://calendly.com/letscombinate/let-s-combinate-intro-sessionFinished medical devices can create a lot of surprises when they are added to combination product kits.A needle, vial a...

24 Kesä 14min