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 of the EU’s Medica...
24 Jan 202443min
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 ...
18 Jan 202426min
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 files (...
10 Jan 202437min
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 for combination pr...
3 Jan 202434min
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 the container and ...
27 Dec 202339min
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 the quality ...
20 Dec 202333min
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 eb...
13 Dec 202343min
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: - Pharma/MedTech Market and Positioning for Success - Why people leave good companies - Finding Motivation in P...
6 Dec 202328min
