Let's Combinate - Drugs + Devices

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 being a lifelong learner. Andy stresses the importance of honing soft skills for effective leadership and suggest stepping out of the comfort zone by exploring opportunities ou...

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 in international locations like India and China. The discussion outlines the FDA's diverse focus areas, from food to medical devices and clinical trials, and how oper...

On this episode, I was joined by Jim Fries, CEO of Rx360. On this episode, Jim discusses the critical aspects of audits in medical technology and pharmaceutical sectors. He provides insight into the joint audit program that RX-360 rolled out, its working, and benefits. He addresses the challenges faced, emphasizing the need for relationship building and constant growth via listening and questionin...

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 provides advice for people considering their career paths and emphasizes the importance of gaining expertise in a particular area before making significant career changes. He also...

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), focusing on the distinctions between roles such as legal manufacturer, distributors, importers, authorized reps, and persons responsible for regulatory compliance. Munir ex...

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 delves into the differences between isolators and RABs—two types of equipment used in clean rooms, critical for sterile processing. David also starts to touch on the standards a...

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 their differences. Drawing on his industry experience, he explains advantages, challenges, and practical ways to handle and maintain these files in biopharma companies. Doug pr...

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 extends to the comparison connecting safety and quality, the importance of cross-functional teams for risk management, and the approach towards health hazard assessments. Addit...

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 being sterilized. Jeanne discusses its application in medical devices, the challenge of permeability, and its comparative cost-effectiveness. Jeanne delves into how the sterilizat...

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 generic drug manufacturing overseas. Eban highlights the need for improving transparency in the pharmaceutical industry. She shares some inspiring stories of dedicated pro...

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 pros and cons, as well as their environmental impacts. Jeanne also delves into the practical considerations associated with this sterilization method. This includes important fac...

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 Work, Insourcing, On-Shoring in US Manufacturing Ira Mann is President, IQ Referrals. With more than 20 years in the recruiting industry, Ira is an expert at placing top profess...

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 -Cycle Development and Validation -Overkill Cycles vs Product Specific Cycles -Parametric Release of Steam Sterilized Products  Jeanne Moldenhauer is subject matter expert on a v...

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 What Country has the Best Healthcare by Ezekiel Emanuel  Switch by Dan and Chip Heath Managing Oneself by Peter Drucker Bottle of Lies by Katherine Evan The Pyramid Principle...

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 Transfer Building Trust with CXO's and Leveraging Surveys The future of the CDMO Market Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Qual...

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: - Protecting the Patient at All Costs - Quality Leadership and being a Chief Quality Officer in Big Pharma - Supply Chain Security - Generic Drugs and Shortages Martin Van Triest...

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 a device background Non-Clinical eCTD Module 4 Clinical eCTD Module 5 Margaret Jenkins is the Founder and Principal at Global Pharma Solutions where she works closely wit...

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 new technologies in Quality and Regulatory Affairs - Removing the tribal knowledge barrier Michelle Wu is the Founder and CEO of NyquistData Inc. Michelle has over seven years o...

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 Michelle's Podcast RAQA Today. Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submiss...

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 - Changes in Data Logger Technology - Cold Chain vs. Ambient Nathan Roman is a highly accomplished expert in equipment commissioning, qualification, and validation, with over 23 years...

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 Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable D...

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 Studies in readiness for IND Submission URRA Human Factors Validation vs. Design Validation Sara Waxberg McNew is the Chief Scientific Officer at Design Science, a human factors fir...

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 with Contraindications - Clinical Trial Monitoring in the Future - Chaining Technology and Re-Training Behavioral Change Charles Gellman is the CEO & Co-Founder of HiDO Health. N...

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 Challenges Defining Accountability from a Quality World-View Good Written Human Guidance Automating Procedure and QMS Feedback Categorizing Deviations Appropriately...

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 Clinical Trials in Australia Australia Regulatory Pathways - Core A and Core B Megan Polidano is the Head of Clinical and Regulatory affairs at Vaxxas. Megan has worked i...