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...
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 ...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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 ...
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 ...
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...
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...
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...
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...
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...
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...
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...
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...
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 ...
On this episode, I was joined by Amy Wilson and Cliff Berry, authors of " Do Quality Differently: The Playbook for Creating More Success in Biopharma (or Any) Manufacturing". Amy and Cliff walkthrough: Human Performance and...
On this episode, I was joined by Megan Polidano, Head of Clinical and Regulatory affairs at Vaxxas. Megan walks through: Micro-Array Patches and Needle Free Injections EPAR's and AusPAR's Combination Products in Australia Cli...