Episodes
125 - Unpacking the Quality Management System Regulation(QMSR) Final …
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 Introduction 05:09 Initial Reactions to the idea of the...
124 - 5 Steps to Becoming a Phenom Quality Pro with Andy Robertson
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 b...
123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, D…
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...
122 - Intricacies of Joint Audits, Rx360, Supply Chain Security, Netw…
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 consortium, RX-360, that focuses on supply chain ...
121 - Bench Scientist to Commercial Leader, Amgen in the early days, …
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 provi...
120 - EU MDR R&R: What's the difference between Legal Manufacturer, A…
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...
119 - What are the basics of Clean Rooms, RABS and Isolators in ISO14…
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 de...
118 - What are Drug/Device Master Files and When to Use for Combinati…
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 t...
117 - Post Market Surveillance, Safety Reporting, Databases, Platform…
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 e...
116 - Gas Sterilization, ETO, Pre-Conditioning, Materials, Different …
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 bein...
115 - Bottle of Lies, Generic Drugs Quality, Ranbaxy, Audits, and Ins…
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 generi...
114 - Irradiation Sterilization, Gamma, X-Ray, E-Beam, Dosimeters, an…
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 pro...
113 - Pharma/MedTech Market, Why Good People Leave, Finding Motivatio…
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 Wo...
112 - Steam Sterilization, Moist/Dry Heat, Biological Indicators, Cyc…
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 ...
111 - 7 Books to level up for MedTech, BioTech and Combination Produc…
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 Crosby The Combination Products Handbook by Susan Needle ...
110 - CXO/CDMO in the future, Supply Chain, Reverse Knowledge Transfe…
On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: Dealing with CDMO's and CXO's Supply Chain and Logistics and Pharma and Medical Devices Reverse Knowledge...
109 - Protecting Patients at All Costs, Being a CQO in Big Pharma, Su…
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 at Amgen and Former CEO at Civica Rx . Martin and I discuss: - P...
108 - Clinical Interpretation, Non-Clinical and Clinical CTD Modules …
On this episode I was joined by Margaret Jenkins, who's the Founder and Principal at Global Pharma Solutions. Margaret and I discuss: Clinical Data interpretation and authoring eCTD Module 2 Overview Learning drug assays with...
107 - Distilling Decades of MedTech Data, Generative AI, and Doing Wi…
On this episode I was joined by Michelle Wu, CEO and Founder of Nyquist. On this episode Michelle and I discuss: - Pre-Trained Models and Generative AI - Distilling Decades of MedTech Data/Historical Data Review - Adopting n...
106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and …
On this episode, Michelle Lott of LeanRAQA walks the listeners through 8 FDA Databases and how to use them! If you'd like to hear more about Michelle checkout episode 031, 077, checkout Michelle's Blog @ LeanRAQA.com and Mich...
106 - Temperature Mapping, Validation, Data Loggers, Cold Chain, Moni…
On this episode, I was joined by Nathan Roman, an expert in temperature mapping and environmental validation. On this episode, Nathan and I discuss: - Temperature Mapping and Monitoring - Validation and Commissioning - Change...
105 - Triathlon: The Combination Products of Sport, 8 Lessons from Ir…
On this episode, I reflect on 8 lessons I learned from recording 100 Episodes of the Combinate Podcast and Ironman Chatanooga. Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a background in Qua...
104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre…
On this episode, I was joined by Sara Waxberg MacNew, Chief Scientific Officer at Design Sciences. On this episode Sara and I discuss: New FDA Guidance: Critical Task Definition for Combination Products Pre-Clinical HF Studie...
103 - Prescription Reconciliation, Medication Error Reduction, Automa…
On this episode, I was joined by Charles Gellman, CEO of HiDO. - How to know people are actually taking their medications - Eliminating Medication Errors in the Home - Medication Reconciliation, Drug Libraries and Dealing ...