Episodes
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 ...
102 - Human Error, Doing Quality Differently, Defining Accountability…
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...
101 - Micro-Array Patches, Combination Products in Australia, Differe…
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...
100 - PQMCoach, Our First Recording, Quality (Big Q/little q), Why Pr…
On this episode, I was joined by one of my favorite guests, Larry Mager of Mgmt-Ctrl and PQMCoach.com. Larry walks through: Episode 100 and the first recording with Larry! Quality - Big Q/little q Building a QMS and Commercia...
099 - Medical Device vs. Medicinal Product Reviews in the EU, Working…
On this episode, I was joined by Janine Jamieson, European Editor at International Pharmaceutical Quality. In this episode, Janine walks through: Medical Device vs. Medicinal Product Reviews in the EU, Working at MHRA as a Pr...
098 - MedTech vs. Aerospace Risk Management, AFAP vs. ALARP/ALARA, Qu…
On this episode I was joined by Bijan Elahi, Award winning Medical Device Risk Management author, educator and consultant. Bijan walks through: MedTech vs. Aerospace - Differences in Risk Management Approaches Risk Control/Re...
097 - Predictive Quality, Business Process Capabilities, 3 Lines of Q…
On this episode, I was joined by one of my favorite guests, Larry Mager of Mgmt-Ctrl and PQMCoach.com. Larry walks through: Predictive Quality Management and PDCA Business Process Capabilities and process stewardship 3 Lines ...
096 - 096 - Pharma Waste Management, Sustainability, What Happens to …
On this episode I was joined by Heather Johnson who's the CEO of Ingenium. In this episode, expect to learn: • Why Waste Management in Pharma might be more complicated than you might think • Different kinds of sharps, why sha...
095 - How FMEA fits into ISO14971, Probabilities, Severity of Harm, R…
On this episode, I was joined again by one of my favorite people in risk management, Naveen Agarwal. In this episode, Naveen discussses:- How FMEA's fit into ISO14971- pFMEA's from External Partners and linking to risk file...
094 - Connected Combination Products, Product Traceability, Regulatin…
On this episode, I was joined by Rumi Young, Director of Regulatory Policy at Beckton Dickinson(BD). Rumi walks through: Connected Devices and Combination Products How Regulators approach regulating new technologies Traceabil...
093 - Combination Products Handbook Part 2: Supplier Management, Drug…
On this episode, I was joined by Susan Neadle, Principal Consultant and President of Combination Products Consulting Services LLC. Susan and I discuss: Supplier Management for Combination Products Drug & Device Analytical Tes...
092 - Putting it all together: Drug cGMP’s 210/211/ICH and Device QMS…
On this episode I was joined by Aaron Snyder, VP of Quality Assurance at Allotex. Aaron discusses:• Distinguishing differences in framework between the Device QSR/QMS and Drug cGMP’s• Learnings from Training FDA CDER and...
091 - Combination Products Handbook Part 1: Foundation, Learning from…
On this episode, I was joined by Susan Neadle, Principal Consultant and President of Combination Products Consulting Services LLC. Susan and I discuss: Part 1 of The Combination Products Handbook: A Practical Guide to Combina...
090 - Software Validation, Automation, No-Code Quality Tools and QMS …
On This Episode, I was joined by Harsh Thakkar, CEO of Qualtivate. Harsh walks through: - Automating Quality with No Code Tools - Software Validation - Infrastructure Software - Out of the Box - Configured Software - Custom S...