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Subhi Saadeh
Combinate Podcast - Combining Drugs and DevicesEpisodes
Subhi Saadeh
Combinate Podcast - Combining Drugs and Devices
A weekly Science podcast
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Episodes of Combinate Podcast
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On this episode I was joined by Chuck Ventura, Founder of Ventura Solutions and CEO of HemoTek. On this episode Chuck walks through:00:29 Design Changes When No DHF Exists03:30 Challenges and Strategies in Document Management04:49 Improving
On this episode, I was joined by Tony Watson, Vice President of Regulatory and Quality at Windgap Medical. On this episode, Anthony discusses:03:11 The Formation and Impact of the Office of Combination Products04:16 Challenges and Changes in
On this episode, I was joined by Richard Koch, Founder of KochSaMD. Richard discusses: 00:29 Exploring Software's Role in Medical Devices02:29 Deep Dive into Cloud-Based Medical Devices06:29 The Intricacies of Software Development in Medica
On this episode, I was joined by Devon Campbell, Founder, Prodct LLC + CPO, myBiometry.Devon discusses:02:20 The Journey to Consulting: A Year of Saying No03:09 Advising Startups: The Role of a Consultant05:08 The Shift to Consulting: E
On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses: 00:56 Evolution of Industry Standards02:00 The Impact of Standards on Medical Device Development02:10 St
On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting. Jeanne and I discuss:- Assessing Drugs, Devices, and Combination Products for Sterility Methods- Regulatory Frameworks and EMA's Decision Tree
On this episode I was joined by Aaron Snyder, VP of Quality Assurance at Allotex. Aaron discusses: 00:58 Exploring the Impact of QMSR on Medical Device Companies02:19 UDI Regulations05:18 Understanding the FDA's Approach to QMSR and Complian
On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, expect to learn from Alan about how reliability engineering concepts can be used for single use combinati
On this episode, I was joined by Former FDA Investigator and Managing Consultant of Practical Compliance Results, Vin Cafiso. Vin discusses: 01:35 Journey from Premed to FDA Investigator: VIN's Story07:25 Understanding the Impact of QMSR on
On this episode I was joined by Naveen Aggarwal founder of Creative Analytic Solutions and host of "Let's talk risk". In this episode, Naveen walks through the big changes to risk management with the QMSR, and risk beyond safety. The episode c
On this episode I was joined by Mat Straton, Founder of Coalition Ltd. In this episode, Mat discusses:01:02 Venturing into Combination Products02:46 Andy's Journey into Healthcare Space04:48 Challenges in Deep Brain Stimulation08:55 The Im
On this episode, I do an active reading to begin to unpack the Quality Management System Regulations(QMSR) Final Rule that was issued by FDA in early February 2024. 0:00 Introduction05:09 Initial Reactions to the idea of the QMSR06:57 Hist
On this episode, I was joined by Andy Robertson, founder of CQE Academy. In this episode, Andy outlines 5 steps to becoming an exceptional quality engineer, such as seeking mentorship, taking on challenging assignments, and being a lifelong l
On this episode, I was joined by Peter Baker, President @ Live Oak QA.The conversation revolves around the speaker's experience working with the FDA, starting from his time in San Francisco and culminating in his experiences in international
On this episode, I was joined by Jim Fries, CEO of Rx360.On this episode, Jim discusses the critical aspects of audits in medical technology and pharmaceutical sectors. He provides insight into the joint audit program that RX-360 rolled out, i
On this episode, I was joined by Sayed Badrawi, Pharma/MedTech Investor and Board Member.Sayed walks through starting at Amgen as a bench scientist and transitioning to the commercial side of the Pharma industry. Sayed provides advice for peop
In this special episode of the comedy podcast, host Subhi Sade welcomes Munir Al Azouzi, the founder of Easy Medical Device. Munir shares his expertise on the often confusing topic of the EU’s Medical Device Regulation (EUMDR), focusing on the
On this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc.David discusses his broad background, including his roles in quality manufacturing, product development, and technical transfer. He delves into the diffe
On this episode, I was joined by Douglass(Doug) Mead, Combination Products Expert and Founder of CP Pathways.Doug presents a thorough walkthrough of drug master files (DMFs) and device master files (MAFs), their types, and their differences. D
On this episode, I was joined by Khaudeja Bano, VP of Quality for Combination Products at Amgen.In this episode, the we discuss the details related to post-market safety reporting for combination products. The conversation extends to the comp
In this episode, I was joined by Jeanne Moldenhauer, a sterilization expert to discuss all things gas sterilization.Jeanne and I explore how efficiency is determined by the seal of the container and the type of material being sterilized. Jeann
On this episode, I was joined by Katherine Eban, the New York Times best-selling author of "Bottle of Lies". In this episode, Katherine dives deep into her decade-long investigation into the quality issues prevalent in generic drug manufacturi
On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting.Jeanne talks through the different methods of irradiation like gamma, beta, microwave, x-ray, and ebeam, their respective pros and cons, as well
On this episode, I was joined by Ira Mann, President at IQ Referrals. Ira and I discuss:- Pharma/MedTech Market and Positioning for Success- Why people leave good companies- Finding Motivation in Pharma/Quality- Remote Work, Insourcing, On-
On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting.Jeanne and I discuss: -Steam Sterilization - Moist and Dry Heat-Biological/Chemical Indicators, Placement and Resistance -Cycle Development
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