Podcast

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

November 15, 2023

110 – CXO/CDMO in the future, Supply Chain, Reverse Knowledge Transfer, Trust and Fashionisity with Ben Locwin

On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: Dealing with CDMOs and CXOs Supply Chain and

November 8, 2023

109 – Protecting Patients at All Costs, Being a CQO in Big Pharma, Supply Chain Security and Generic Drugs with Martin Van Trieste

On this episode, I was joined by Martin Van Trieste , Author of Protecting the Patient at All Costs: The Drug Watch Dogs and is the Former Chief Quality Officer

November 1, 2023

108 – Clinical Interpretation, Non-Clinical and Clinical CTD Modules 4 & 5, Pre-IND/IND and Dossiers with Margaret Jenkins

On this episode I was joined by Margaret Jenkins, who's the Founder and Principal at Global Pharma Solutions. Margaret and I discuss: Margaret Jenkins is the Founder and Principal at

October 25, 2023

107 – Distilling Decades of MedTech Data, Generative AI, and Doing Without Tribal Knowledge with Michelle Wu

On this episode I was joined by Michelle Wu, CEO and Founder of Nyquist. On this episode Michelle and I discuss: Key Topics Pre-Trained Models and Generative AI Distilling Decades

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