Podcast

February 7, 2024

122 – Intricacies of Joint Audits, Rx360, Supply Chain Security, and Networking in Pharma/MedTech with Jim Fries

Navigating Audits in Med Tech and Pharma: A Conversation with Jim, CEO of RX-360 In this episode of the Combinate podcast, host Suby interacts with Jim, CEO of a member-driven

January 31, 2024

121 – Bench Scientist to Commercial Leader, Amgen in the early days, Challenges in Commercialization, Working in Startups vs. Large Companies, and Silos with Sayed Badrawi

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

January 24, 2024

120 – EU MDR R&R: What’s the difference between Legal Manufacturer, Authorized Rep, PRRC, Importer and Distributor? with Founder of Easy Medical Device, Monir El Azzouzi

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

January 18, 2024

119 – What are the basics of Clean Rooms, RABS and Isolators in ISO14644 and EU Annex I? with David Simoens

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

January 10, 2024

118 – What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead

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

January 3, 2024

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

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

December 27, 2023

116 – Gas Sterilization, ETO, Pre-Conditioning, Materials, Different Gases, Bioburden, Validation, and Safety with Jeanne Moldenhauer

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

December 20, 2023

115 – Bottle of Lies, Generic Drugs Quality, Ranbaxy, Audits, and Inspiring Quality Pros with NYT Best-Selling Author, Katherine Eban

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

December 13, 2023

114 – Irradiation Sterilization, Gamma, X-Ray, E-Beam, Dosimeters, and Combination Products with Jeanne Moldenhauer

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,

December 6, 2023

113 – Pharma/MedTech Market, Why Good People Leave, Finding Motivation, Onshoring in Pharma and Motivation with Ira Mann

On this episode, I was joined by Ira Mann, President at IQ Referrals. Ira and I discuss: Key Topics Pharma/MedTech Market and Positioning for Success Why people leave good companies

November 29, 2023

112 – Steam Sterilization, Moist/Dry Heat, Biological Indicators, Cycle Development, Validation and Parametric with Release with Jeanne Moldenhauer

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

November 22, 2023

111 – 7 Books to level up for MedTech, BioTech and Combination Product Professionals with Subhi Saadeh

On this solo episode, I go through a list of 7 books I recommend for med tech, biotech and combination product professionals. The books are: Quality is Free by Phillip

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