Subhi Saadeh public
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Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to li ...
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On this episode, I outline an introduction to one of my favorite APQP tools, Production Part Approval Process(PPAP): - What is PPAP - Inputs, Process, Triggers and Interactions - PPAP Elements and Tools - The difference between first article inspection(FAI) and Capability Studies - Applications and Challenges in use Subhi Saadeh is a Quality Profes…
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On this I was joined by Ferdous Al-Faruque, Senior Editor at RAPS. Danny discusses: • Landing in Medical Devices and Pharma Regulatory Affairs • Rules of engagement • On the record, Off the record, On Background • Danny's Process in writing, editing and publishingFerdous Al-Faruque, known as Danny, is Senior Editor at RAPS and specializes in report…
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On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions. Fran and I discuss: (0:00) Component Machinability (3:47) Stopper/Plunger Coating vs Lamination (13:22) Stopper/Plunger Manufacturing (26:14) USP 381/382 Fran DeGrazio is President & Principal Consultant at Strategic Parenteral Soluti…
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On this episode I was joined by Jacob Laporte, Co-Founder of the Novartis Biome. Jacob discusses: (1:56)Harvard PhD to Consulting in Innovation Management (11:50)Core & Non-Core Innovation (21:09)Digital Technologies in Pharma (27:39)Democratizing Access and Clinical Trials (32:35)Proteomics Dr. Jacob LaPorte is an ex-Harvard chemist and ex-McKinse…
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Shaykh Ismail Alqadi is a Qari (professional reciter of the Qu'ran) from Amman, Jordan. He learned the various sciences related to the recitation of the Qu'ran from several teachers and has an ijazah and sanad in the ten different narrations of the Qu'ran. He also has a degree in Islamic studies majoring in Fiqh and Usul. In this podcast, Shaykh Is…
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On this episode, I was joined by Marta New, the CEO of Radyus Research. Dr. New discusses: (0:00) Intro (1:37) Pre-Clinical Planning (7:15) What's the purpose of an IND? (14:10) Administration Route Selection (19:00) Candidate Selection and Animal Models (30:10) Pre-IND Meeting (44:00) IND Submissions and Approval Marta New PhD MBA is the CEO of Ra…
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Mawlana Saaleh Baseer is a brilliant young scholar of Hanafi law and Mughal history from the Bay Area. After completing his memorization of the Qu'ran, he received his Alim degree from Darul Uloom Azaadville in South Africa. Afterwards he went on to pursue a Bachelor's degree from Columbia University where he majored in History. Most recently he ha…
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On this episode, I was joined by Derek Duncan, Director and VP of Product Management at Lighthouse Instruments. Derek walks through: - (2:30) Holistic Approach to CCI - (5:50) Risk Management and CCI - (7:30) Lyophilized vs. Liquid CCI - (12:20) Capping/Crimping Parameters and Residual Seal Force(RSF) - (14:30) EU Annex I and USP 1207 Requirements …
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On this episode, I was joined by Niedre Heckman, MPH, PhD, FRAPS, Director of Regulatory Affairs Strategy, CMC, Medical Devices, Combination Products at Takeda. Niedre discusses:* Common Technical Document* Combination Products Structure for eCTD Submissions* EU vs. US Submission Expectations* Design Controls and Human Factors data placement * Regu…
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On this episode I was joined by Bob Nesbitt, Chair of ISO TC 84 and Director of Combination Products R&D at Abbvie. Bob discusses:- ISO TC 84: Needle Based Injectors, Insulin Syringes, Auto Disable Syringes, On Body Injectors, Sharps Prevention, Cartridge Based Pen Injectors, Inhalers, Single use Drug Delivery devices, Catheters, etc- Crazy Bob's M…
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On this episode, I was joined by Derek Duncan, Director and VP of Product Management at Lighthouse Instruments.Derek walks through: - CCIT vs. Sterility Testing- Difference between Deterministic and Probabilistic Methods- 9 CCI Test Methods in 9 Minutes- CCI vs. Permeation Dr. Duncan began his career at the Dutch Institute for Atomic & Molecular Ph…
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On this episode, I was joined by Rumi Young, Director of Regulatory Policy at Beckton Dickinson(BD).Rumi walks through:- How FDA Reviews Combination Products- Industry's role in shaping policy- Essential Performance Requirements- IMDRF and International Harmonization OpportunitiesRumi Young, Meng, RAC is the Director of Regulatory Policy at Becton …
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On this episode, I was joined by Ramin Rafiei PhD, CEO of Unleash Health. Ramin discusses: Experiences in Integrating Combination Products and Digital Health Prevention + Intervention in Health Care Incentives and Outcomes Unleashing consumer brands to improve health Dr Ramin Rafiei is a senior executive and entrepreneur in healthcare and life scie…
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On this episode of the podcast, I bring back Shaykh Umair Haseeb to talk all things Ramadan. What do we do if we don't prep at all? How do we navigate Ramadan when we're struggling with sins? How do sages of today approach Ramadan? Shaykh Umair is a graduate of Al-Qayrawayin University in Fes, Morocco and is currently serving as Director of Religio…
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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 "The 5 stages of Regulatory Grief" and checkout Michelle's Blog @ LeanRAQA.com) and Michelle's Podcast RAQA Today. Michelle Lott is the founder and principal of leanRAQA, which ha…
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Dr. Yakoob Ahmed is an Ottoman historian with a specialization in late Ottomon history. He received his Ph.D. from the School of Oriental and African Studies (SOAS) at the University of London and he currently teaches at Istanbul University in Turkiye. I had a chance to sit down with Dr. Yakoob after I attended a weekend seminar he did in Chicago o…
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On this episode, I was joined by Joanna Gallant of JGTA. Joanna walks through: Training programs at companies that had consent decrees The difference between good training and bad GMP training Competence in knowledge work Human Error Joanna Gallant is an experienced, solutions-driven Quality and training professional who has spent more than 30 year…
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On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: - FDA Drug Shortages Report - Drug Shortages and Drug Pricing - How he approaches Mastering new skill sets and building deep understanding in new areas Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality a…
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On this episode, I was joined by Christiana Hoffman, Executive Consultant & Business Development Manager at anteris medical GmbH. Christiana walks through: - Article 117 requirements for Combination Products in EU - Notified Body Opinions, Timelines, and Interactions\ -Reporting for Combination and when does Eudamed Apply Christiana is a medical de…
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In this episode, I bring back my good friend Nabeel Azeez who's a Dubai based copywriter to talk about his latest project, "40 Hadith on Masculinity: How to be a Good Man". We discuss how he went about commissioning the project and tackled a few examples of things related to masculinity that content creators struggle with. We also discussed his for…
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On this episode, I was joined again by one of my favorite people in risk management, Naveen Agarwal of Creative Analytics Solutions and ExceedQM. Naveen discusses: The Anatomy of a Hazard Hazard Source(HS), Initiating Mechanisms (IM) and Target-Threat Outcome (TTO) Clifton Ericcson How concepts/tools like these fit into the ISO14971 and ISO TR 2497…
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Jumha Aburezeq is an active entrepreneur, philanthropist, and founder of StoopidFit. To date, he's helped over 1000 people across the world gain freedom with their body, mind and food with his trademark 3 Phase Fat Loss System. To connect with Jumha and learn more about his programming, go to: https://stoopidfit.com/ Resources for "Sultans and Snea…
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On this episode, I was joined by Dan Formosa, legendary designer and founder of ThinkActHuman. On this episode, Dan walks through:- Eliminating the need for instruction through good design- Drug/Device Combination Product Usability- Collaborating with OXO on a Pre-Filled Syringe- Creating the worlds first toothbrush designed for children- Usability…
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John Kiser is a former international technology broker and author. He wrote "Commander of the Faithful: The Life and Times of Emir Abd el-Kader, A Story of True Jihad". I had the chance to discuss the character of Emir Abd el-Kader with John and we talked about the lessons that people today can take away from his life. Currently, John enjoys raisin…
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On this episode, I was joined by Etienne Nichols, who is a Medical Device Guru and Host of the Global Medical Device Podcast. Etienne Discusses: -Translating lessons from the Steel Industry into MedTech -His experience on combination products - What is the most important quality system element? Etienne Nichols is a Medical Device Guru and Mechanica…
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On this episode, I was joined by Paul Jansen, who's a drug/device consultant, advisor, and board member in the combination products space. Paul discusses: - His experience leading combination product focused organizations at Eli Lilly & Sanofi - The first autoinjectors and the history surrounding ISO 11608 - Managing a product line, owning P&L and …
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On this episode, Michelle Lott discusses the EU MDR Extension that was formalized by the European Commission and what it means for industry. If you'd like to hear more about Michelle checkout episode 031 "The 5 stages of Regulatory Grief" and checkout Michelle's Blog @ LeanRAQA.com) and Michelle's Podcast RAQA Today.Michelle Lott is the founder and…
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On this episode I was joined by David Rutledge, author of Mythical Medical and CEO of Global Strategic Solutions. David Discusses: · His book Mythical Medical · Benefit (As part of Benefit/Risk) · PRRC Role and EU MDR David R Rutledge, Pharm.D., FCCP, FAHA is a results-oriented consultant for clinical evaluation and investigation, clinical risk man…
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On this episode I was joined by Jane M. True, VP, mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead at Pfizer. • Following career tracks, "experience", and non-linear career progression • Practical tips for presenting and nerves • Storyboarding and the Minto Principle • How Flu Vaccines are developed globally • mRNA and what i…
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Shaykh Umer Khan is a rare individual who has excelled in both corporate America as well as Islamic studies. Up until recently, he was the VP of Information Technology and Security at SpaceX, where he reported directly to Elon Musk. He recently left to become Chief Information and Security Officer at another firm. While progressing through his corp…
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On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions. Fran and I discuss: Her career at West Pharmaceuticals starting in the lab and retiring as Chief Scientific Officer Becoming experienced in Marketing, QA and RA What the C-Suit expects from individual contributors How to recognize opp…
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This solo episode walks through 8 of the quality lessons I learned by losing 100lbs over the last 10 years. They are: Change takes time Change starts from a small decision More pain does not equal more pain/Quality is free. Prevention is part of performance Environment is as critical as habit Managing constraint changes as the quality journey evolv…
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On this episode, I was joined again by Skip Creveling. During the last episode, Skip walked through Design for Six Sigma(DFSS), and finding/measuring what's important(critical parameters and tolerancing). In this episode, he discusses: Design and Development processes in Pharma and MedTech How DFSS can be integrated into lifecycle management Design…
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On this episode, I was joined by Niedre Heckman, MPH, PhD, FRAPS, Director of Regulatory Affairs Strategy, CMC, Medical Devices, Combination Products at Takeda.Niedre discusses:- Challenges with global regulatory strategies for combination products- Impact of regulatory strategies on patients and product adoption- Becoming an FRAPS, and building wi…
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I love talking to fellow podcasters and on this episode, I was joined by Dr. Stefan Walzer, the CEO of MArS Market Access & Pricing Strategy. Stefan discusses: Discounts, Rebates, and how Co-Payment is different in Europe How data is presented to payers in Europe and European Reimbursement Germany/AMNOG Process NegotiationDr. Stefan Walzer is a hea…
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On this episode, I was joined by Skip Creveling, President and Founder of PDSS Inc.Skip walks through: Learning from Genichi Taguchi and Stuart Pugh The 7 Steps to Robust Design Design for Six Sigma(DFSS) Six Sigma in Marketing Tolerancing and Critical ParametersClyde "Skip" Creveling is the President & Founder of PDSS Inc. Skip has led the DFSS in…
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Elena Kyria, CEO of Elemed joins the podcast and discusses:- Why People stay in roles and why they leave-Starting Elemed-The trusted advisory role that recruiters play-Community work on EU MDR and RAPSElena Kyria is an award-winning talent acquisition specialist in the Medtech industry. She is the CEO of Elemed and in charge of executive placements…
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On this episode, I was joined by Ethan Drower, of Citemed. Ethan is a prolem-driven, software engineer and fellow Chicagoan who's focused on making literature review for EU MDR Clinical Evaluation Reports(CER) more efficient, traceable and robust.Ethan and I discuss:- A problem-driven career- Challenges with EU MDR Clinical Evaluation Reports(CER's…
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Andrew Tate's conversion to Islam has sparked a discourse in the Muslim community regarding the conversion of individuals who are coming to Islam from a past life that seems antithetical to Islamic teachings. In this panel, we discuss Tate's conversion from various angles with Dr. Abdullah bin Hamid Ali, Shaykh Mustafa Umar and Nabeel Azeez. All th…
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On this episode, I was joined again by Dr. Khaudeja Bano, Vice President of Combination Product Quality at Amgen. On this episode Khaudeja and I discuss:- PMSR and Risk Management - Patient Safety, Pharmacovigilance, Medical Affairs, Clinical Affairs in Medical Device and Pharma companies.- PMSR Regulatory Landscape Globally (Outside of the US)Dr. …
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Subhi Saadeh is a quality engineer, triathlete/marathoner, podcaster and coffee aficionado. He works in the pharmaceutical industry and is the host of the Combinate Podcast, a show that's focused on Quality in BioTech and MedTech. In this episode, we discuss Subhi's approach to work and learning. He shares how his discipline spreads out to other as…
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On this episode, I was joined by Rizwan Chaudhrey, of RSK Life Sciences Media. Rizwan and I discuss: Launching Chats with Chaudhrey during the Pandemic Conferences and Expos How to use LinkedIn to build your personal brand Getting StartedRizwan is a blogger on Life Science/ Pharma Bio-Pharma from Drug Discovery to Drug Delivery and all things in be…
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On this episode I was joined by Darshan Kulkarni, Host of DarshanTalks, Attorney at the Kulkarni Law Firm and Adjunct Law Professor at Drexel University. Darshan and I discuss: - Non-Promotional Speech and Scientific Discussion - Medical Affairs vs. Sales and interaction with HCP's - Free Speech in Tech and what it might mean for Pharma Darshan Kul…
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On this episode, I was joined by Alexandra Benbadis, Usability Leader at Sanofi. Alexandra and I discuss:- Critical Tasks: What the guidance says , how to select them and what it means for HF study design- Knowledge Tasks: Meeting regulatory expectations and evaluation the IFU- Usability, HF Studies and Residual RiskPrior to joining Sanofi as Usabi…
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On this episode, I was joined by Richard Houlihan, CEO of Eirmed. Richard and I discuss: - History of Eudamed (Starting with EU Legislation in 2010) - The 6 modules of Eudamed (PMS, Vigilance & Post-Market Surveillance, Clinical Investigations, Certificates, Market Surveillance, Actor Registration) - Responsibilities for Economic Operators (Manufac…
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On this episode I was joined by Chris Tsai from Boothroyd Dewhurst, Inc. Chris and I discuss: Value Engineering at Eastman Kodak in the 1990's Inventing and Deploying Concurrent Engineering Defining Design Robustness QFD and Design Control in Non-Regulated Industries Verb/Noun Pairs and Product Development Design for Manufacturability and Assembly …
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Paul Williams is a blogger and bibliophile based out of London and the South of France. He hosts the popular YouTube channel Blogging Theology, which has reached over 170,000 subscribers at the time of this recording. In this episode we talk about why Blogging Theology has been so popular in the day and age of clickbait videos. We also explore how …
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On this special episode of the podcast, I was joined by Larry Mager. As the 52nd episode, I wanted to thank Larry for being my first interview a little more than a year ago! On this episode, Larry and I discuss: - His experiences with Pharma and CRO clients vs. Medical Device - Predictive Quality Management across both medical device and pharma - M…
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Shaykh Mustafa Umar is the founder and president of California Islamic University, the Director of Education and Outreach at the Islamic Institute of Orange County, an executive member of the Fiqh council of North America, and most recently a Research Fellow at Yaqeen Institute. He began his Islamic studies overseas in India and Egypt before obtain…
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