Combinate Podcast - Combining Drugs and Devices
By Subhi Saadeh
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Category: Life Sciences
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Subscribers: 4
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Episodes: 139
Description
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 listen and together we can simplify by Combinating!
| Episode | Date |
|---|---|
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136 - Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura
|
May 15, 2024 |
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135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson
|
May 08, 2024 |
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134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch
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May 01, 2024 |
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133 - A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell
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Apr 24, 2024 |
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132 - IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner
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Apr 17, 2024 |
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131 - Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer
|
Apr 10, 2024 |
|
130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder
|
Apr 03, 2024 |
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129 - Reliability for Combination Products, Infusion Pumps and Recalls, Responding to Health Disasters with Public Health Service, and FDA Rule-making Process with Captain Alan Stevens
|
Mar 27, 2024 |
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128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture
|
Mar 20, 2024 |
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127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal
|
Mar 13, 2024 |
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126 - Combination Products Collaboration, Turnover on MedTech/Pharma Project Teams, and Lessons from working with Intel's CEO with Mat Stratton, Founder of Coalition Ltd
|
Mar 06, 2024 |
|
125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh
|
Feb 28, 2024 |
|
124 - 5 Steps to Becoming a Phenom Quality Pro with Andy Robertson
|
Feb 21, 2024 |
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123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker
|
Feb 14, 2024 |
|
122 - Intricacies of Joint Audits, Rx360, Supply Chain Security, and Networking in Pharma/MedTech with Jim Fries
|
Feb 07, 2024 |
|
121 - Bench Scientist to Commercial Leader, Amgen in the early days, Challenges in Commercialization, Working in Startups vs. Large Companies, and Silos with Sayed Badrawi
|
Jan 31, 2024 |
|
120 - EU MDR R&R: What's the difference between Legal Manufacturer, Authorized Rep, PRRC, Importer and Distributor? with Founder of Easy Medical Device, Monir El Azzouzi
|
Jan 24, 2024 |
|
119 - What are the basics of Clean Rooms, RABS and Isolators in ISO14644 and EU Annex I? with David Simoens
|
Jan 18, 2024 |
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118 - What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead
|
Jan 10, 2024 |
|
117 - Post Market Surveillance, Safety Reporting, Databases, Platforms Health Hazards Assessments and Product Responsibilities with Khaudeja Bano
|
Jan 03, 2024 |
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116 - Gas Sterilization, ETO, Pre-Conditioning, Materials, Different Gases, Bioburden, Validation, and Safety with Jeanne Moldenhauer
|
Dec 27, 2023 |
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115 - Bottle of Lies, Generic Drugs Quality, Ranbaxy, Audits, and Inspiring Quality Pros with NYT Best-Selling Author, Katherine Eban
|
Dec 20, 2023 |
|
114 - Irradiation Sterilization, Gamma, X-Ray, E-Beam, Dosimeters, and Combination Products with Jeanne Moldenhauer
|
Dec 13, 2023 |
|
113 - Pharma/MedTech Market, Why Good People Leave, Finding Motivation, Onshoring in Pharma and Motivation with Ira Mann
|
Dec 06, 2023 |
|
112 - Steam Sterilization, Moist/Dry Heat, Biological Indicators, Cycle Development, Validation and Parametric with Release with Jeanne Moldenhauer
|
Nov 29, 2023 |
|
111 - 7 Books to level up for MedTech, BioTech and Combination Product Professionals with Subhi Saadeh
|
Nov 22, 2023 |
|
110 - CXO/CDMO in the future, Supply Chain, Reverse Knowledge Transfer, Trust and Fashionisity with Ben Locwin
|
Nov 15, 2023 |
|
109 - Protecting Patients at All Costs, Being a CQO in Big Pharma, Supply Chain Security and Generic Drugs with Martin Van Trieste
|
Nov 08, 2023 |
|
108 - Clinical Interpretation, Non-Clinical and Clinical CTD Modules 4 & 5, Pre-IND/IND and Dossiers with Margaret Jenkins
|
Nov 01, 2023 |
|
107 - Distilling Decades of MedTech Data, Generative AI, and Doing Without Tribal Knowledge with Michelle Wu
|
Oct 25, 2023 |
|
106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott
|
Oct 24, 2023 |
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106 - Temperature Mapping, Validation, Data Loggers, Cold Chain, Monitoring and Commissioning with Nathan Roman
|
Oct 11, 2023 |
|
105 - Triathlon: The Combination Products of Sport, 8 Lessons from Ironman Chatanooga and 100 Episodes with Subhi Saadeh
|
Oct 04, 2023 |
|
104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre-IND HF Studies with Sara McNew
|
Sep 27, 2023 |
|
103 - Prescription Reconciliation, Medication Error Reduction, Automated Home Care, Assisted Robotics, Patient Behavioral Monitoring, and the future of Clinical Trials with Charles Gellman
|
Sep 20, 2023 |
|
102 - Human Error, Doing Quality Differently, Defining Accountability, Written Human Guidance, Blue Line vs. Black Line and Categorizing Deviations with Amy Wilson and Cliff Berry
|
Sep 13, 2023 |
|
101 - Micro-Array Patches, Combination Products in Australia, Differences between TGA and RoW, Novel Delivery Systems, and Clinical Trials with Megan Polidano
|
Sep 06, 2023 |
|
100 - PQMCoach, Our First Recording, Quality (Big Q/little q), Why Predictive Quality Management, and Communicating Quality with Larry Mager
|
Aug 30, 2023 |
|
099 - Medical Device vs. Medicinal Product Reviews in the EU, Working at MHRA, Notified Bodies, EU MDR, ICH Q6 and Writing All About It with Janine Jamieson
|
Aug 23, 2023 |
|
098 - MedTech vs. Aerospace Risk Management, AFAP vs. ALARP/ALARA, Quantifying Benefit, Risk Control Measures, and Risk Management Reports with Bijan Elahi
|
Aug 16, 2023 |
|
097 - Predictive Quality, Business Process Capabilities, 3 Lines of Quality Defense, TOC, COSO and Business Risk with Larry Mager
|
Aug 09, 2023 |
|
096 - Pharma Waste Management, Sustainability, What Happens to Sharps, Disposal and Zero Waste with Heather Johnson
|
Aug 02, 2023 |
|
095 - How FMEA fits into ISO14971, Probabilities, Severity of Harm, RPN's, pFMEA's and making it simpler with Naveen Agarwal
|
Jul 26, 2023 |
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094 - Connected Combination Products, Product Traceability, Regulating New Products, Pre-Determined Changes and AI/ML with Rumi Young
|
Jul 19, 2023 |
|
093 - Combination Products Handbook Part 2: Supplier Management, Drug/Device Analytical Testing, Biologics, Digital/Connected Health and Changing Regulatory Landscape with Susan Neadle
|
Jul 12, 2023 |
|
092 - Putting it all together: Drug cGMP’s 210/211/ICH and Device QMS 820/ISO13485 with Aaron Snyder
|
Jul 05, 2023 |
|
091 - Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan Neadle
|
Jun 28, 2023 |
|
090 - Software Validation, Automation, No-Code Quality Tools and QMS with Harsh Thakkar
|
Jun 21, 2023 |
|
089 - Talking HealthTech Podcast, Consistency, Australian Innovation in HealthTech, Content, and Community with Peter Birch
|
Jun 14, 2023 |
|
088 - Production Part Approval Process(PPAP) with Subhi Saadeh
|
Jun 07, 2023 |
|
087 - From Crime Reporting to Regulatory Affairs and On/Off The Record with Ferdous Al-Faruque
|
May 31, 2023 |
|
086 - Elastomers - Stopper and Plunger Manufacturing, Processing and USP 381/382 with Fran DeGrazio
|
May 24, 2023 |
|
085 - Digital Innovation, Proteomics, Core & Non-Core Innovation, Consulting after Academia, Democratizing Access and Clinical Trials with Jacob Laprote
|
May 17, 2023 |
|
084 - Drug Discovery, Candidate Selection, Pre-Clinical Development, IND Submissions, Administration Route Selection, TPP and Toxicology with Marta New
|
May 10, 2023 |
|
083 - Holistic Approach to Container Closure Integrity, Capping/Crimping, RSF, and Annex I/USP 1207 Requirements with Derek Duncan
|
May 03, 2023 |
|
082 - CTD Structure for Combination Products, US vs. EU Submissions and Regulatory R&R with Niedre Heckman
|
Apr 26, 2023 |
|
081 - ISO TC 84, ISO11608, Committee Work and Advancing the State of the Art with Bob Nesbitt
|
Apr 19, 2023 |
|
080 - 9 CCI Tests in 10 Minutes, Probabilistic vs. Deterministic, and CCI vs. Permeation with Derek Duncan
|
Apr 12, 2023 |
|
079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young
|
Apr 05, 2023 |
|
078 - Prevention is Not New, Incentives in Health Care, and Integrated Combination Products with Ramin Rafiei
|
Mar 29, 2023 |
|
077 - 8 Databases and How To Use Them with Michelle Lott
|
Mar 22, 2023 |
|
076 - GMP Training, Competence, Human Error and Mentorship with Joanna Gallant
|
Mar 15, 2023 |
|
075 - Shortages, Pricing, Mastering New Skills, and Building Deep Understanding with Ben Locwin
|
Mar 08, 2023 |
|
074 - Article 117, EU MDR extension, Notified Body Opinions, Timing and Interaction with Christiana Hoffman
|
Mar 01, 2023 |
|
073 - Anatomy of a Hazard, Clifton Ericcson, ISO 14971/24971 Risk Management with Naveen Agarwal
|
Feb 22, 2023 |
|
072 - OXO PFS, Drug/Device Usability, Toothbrushes for Children, Epicurious Series and Baseball with Dan Formosa
|
Feb 15, 2023 |
|
071 - Steel Industry to MedTech & Important Quality Systems with Etienne Nichols
|
Feb 08, 2023 |
|
070 - The First Auto-Injectors, ISO-11608 History, and Managing Product with Paul Jansen
|
Feb 01, 2023 |
|
069 - EU MDR Extension with Michelle Lott
|
Jan 25, 2023 |
|
068 - Benefit/Risk Ratios, PRRC, and Mythical Medical with David Rutledge
|
Jan 18, 2023 |
|
067 - mRNA, Flu Vaccines, Good Presentations, and Non-Linear Career Paths with Jane M. True
|
Jan 11, 2023 |
|
066 -Scientist to CSO, Learning QA/RA & Marketing, and Saying Yes to Oppurtunities with Fran DeGrazio
|
Jan 04, 2023 |
|
065 - "8 Quality Lessons from Losing 100 Lbs " with Subhi Saadeh
|
Dec 28, 2022 |
|
064 - Pharma and Medical Device Development Processes, DFSS and Design Reviews with Skip Creveling
|
Dec 21, 2022 |
|
063 - Combination Products Regulatory, Going Wide, and Patient Impact with Niedre Heckman
|
Dec 14, 2022 |
|
062 - Reimbursement in Europe, Access, Rebates, and Negotiation with Stefan Walzer
|
Dec 07, 2022 |
|
061 - Taguchi, Pugh, DFSS, Robust Design and Tolerancing with Skip Creveling
|
Nov 30, 2022 |
|
060 - Why People Leave, Starting Elemed and Trusted Advisory with Elena Kyria
|
Nov 23, 2022 |
|
059 - Literature Review, EU MDR CER’s, and Being Problem Driven with Ethan Drower
|
Nov 16, 2022 |
|
058 - PMSR Globally, Different Clinical Roles and Risk Management with Khaudeja Bano
|
Nov 09, 2022 |
|
057 - Conferences, Expos, LinkedIn and Launching a Podcast with Rizwan Chaudhrey
|
Nov 02, 2022 |
|
056 - "Non-Promotional Compliance" with Darshan Kulkarni
|
Oct 26, 2022 |
|
055 - "Critical Tasks and Knowledge Tasks" with Alexandra Benbadis
|
Oct 19, 2022 |
|
054 - "EUDAMED" with Richard Houlihan
|
Oct 12, 2022 |
|
053 - "Duct Tape and Bubble Gum" with Chris Tsai
|
Oct 05, 2022 |
|
052 - “All Work is Process” with Larry Mager
|
Sep 28, 2022 |
|
051 - "EU MDR" with Bassil Akra
|
Sep 21, 2022 |
|
050 - "When No One is Listening" with James Somauroo
|
Sep 14, 2022 |
|
049 - "What Does the Data Say?" with Shannon Hoste
|
Sep 07, 2022 |
|
048 - "Materials" with Hsinjin Yang
|
Aug 31, 2022 |
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047 - "Truthful Not Misleading" with Darshan Kulkarni
|
Aug 24, 2022 |
|
046 - "Inflation Reduction Act" with Sarfaraz Niazi
|
Aug 17, 2022 |
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045 - "Combination Products around the Globe" with Susan Neadle
|
Aug 10, 2022 |
|
044 -“Market Access” with Kasem Akhras
|
Aug 03, 2022 |
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043 - “Half Knowledge Can Hurt” with Shadeed Salam
|
Jul 27, 2022 |
|
042 - “Reproducible within Limits”
|
Jul 20, 2022 |
|
041 - “Health Citizenship” with Jane Sarasohn Kahn
|
Jul 13, 2022 |
|
040 - “Good Science is Good Science” with Ben Locwin
|
Jul 06, 2022 |
|
039 - "The Camera Didn't Make the Artist Obsolete" with John Nosta
|
Jun 29, 2022 |
|
038 - "Clinical Trials" with Dan Sfera
|
Jun 22, 2022 |
|
037 - Reflections #1 - (Episodes 001-25)
|
Jun 15, 2022 |
|
036 - "Those Moments Keep You Grounded" with Yousef Arman
|
Jun 08, 2022 |
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035 - “Safety is Safety” with Khaudeja Bano
|
Jun 01, 2022 |
|
034 - "Agent" with Mitch Robbins
|
May 25, 2022 |
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033 - "Specialization" with Erik Barkley
|
May 18, 2022 |
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032 - “Quality is Free”
|
May 11, 2022 |
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031 - "The Five Stages Of Regulatory Grief" with Michelle Lott
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May 04, 2022 |
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030 - "Why Don't I Try?" with Marc Koska
|
Apr 27, 2022 |
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029 - "Purpose" with Marla Phillips
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Apr 20, 2022 |
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028 - "How Much Does Poor Quality Cost?" with H. James Harrington
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Apr 13, 2022 |
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027 - "Become a Historian of the Problem" with Duane Mancini
|
Apr 06, 2022 |
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026 - "Quality" with H. James Harrington
|
Mar 30, 2022 |
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025 - “The Frying Pan to the Fire” with Edwin Bills
|
Mar 23, 2022 |
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024 - "Operating Under Constraints "with Naveen Agarwal
|
Mar 16, 2022 |
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023 - "The Best is Yet to Come" with David Albert
|
Mar 09, 2022 |
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022 - "What Chapter are you in?" with Susan Neadle
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Mar 02, 2022 |
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021 - "Options" with Karandeep Singh Badwal
|
Feb 23, 2022 |
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020- "The Right Words" with Kathy Walsh
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Feb 16, 2022 |
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019 - "Carrying The Bag" with Omar M Khateeb
|
Feb 09, 2022 |
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018 - "The Optimist Plans for Forever" - with Sarfaraz Niazi
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Feb 02, 2022 |
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017 - "Feet First" with Ahmed Zobi
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Jan 26, 2022 |
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016 - "Be More Specific" with Joe Hage
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Jan 19, 2022 |
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015 - "Would You Use it on a Family Member?" with Monir El Azzouzi
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Jan 19, 2022 |
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014A - "The First P: Product" with Larry Mager
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Jan 05, 2022 |
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014B - "The Second P: Process" with Larry Mager
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Jan 05, 2022 |
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014C - "The Final P: People" with Larry Mager
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Jan 05, 2022 |
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013 - “Big Rocks and Little Rocks” with Jumha Abu-Razeq
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Dec 29, 2021 |
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012 - "Asking then Seeing" with Sara Waxberg Mcnew
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Dec 22, 2021 |
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011 - “Long Story Short” with Margot Leitman
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Dec 15, 2021 |
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010 - "Don't Make Assumptions" with David Simoens
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Dec 08, 2021 |
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009 - “Cutting Through the Noise” with Charles Ventura
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Dec 01, 2021 |
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008 - "Follow the Opportunity" with Marta New
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Nov 24, 2021 |
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007 - "Beyond The Obvious" with Miiri Kotche
|
Nov 17, 2021 |
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006 - “The Courage to Start” with John Bingham
|
Nov 10, 2021 |
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005 - “Compassionate Product Development” with Cameron Jones
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Nov 03, 2021 |
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004 - “Until They Know How Much You Care” with Andy Robertson
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Oct 27, 2021 |
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003 - “Standard Understanding” with Mark Swanson
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Oct 20, 2021 |
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002 - “Seeing David in the Stone: Predictive Quality Management” with Larry Mager
|
Oct 14, 2021 |
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001 - “Learning Never Exhausts the Mind” with Rick Doe
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Oct 06, 2021 |