Let's Combinate - Drugs + Devices cover art

All Episodes

Let's Combinate - Drugs + Devices — 254 episodes

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Title
1

247 - Why Everyone in Pharma and MedTech Should Work in Quality

2

246 - The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)

3

245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector

4

244 - 5 Critical Quality Differences Between Drugs and Devices

5

243 - Why Kitting A Finished Medical Device with a Drug Create So Much Work

6

242 - Pharma/MedTech Audits: 6 Strategies for Choosing Where to Start

7

241 - ICH Q14 Explained: Have We Been Validating Methods Backwards?

8

240 - ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy

9

239 - ICH Q12: What’s Binding? Established Conditions and Post-Approval Changes

10

239 - ICH Q11 in 6 Minutes

11

238 - 6 Audit Strategies Every Auditor Should Know

12

237 - ICH Q10: The Pharmaceutical Quality System

13

236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences

14

235 - ICH Q8: How Pharmaceutical Development Actually Works

15

234 - ICH Q7: The GMP Framework for API Manufacturing

16

233 - Most Teams Misunderstand Specifications | ICH Q6

17

232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk

18

231 - Audit Findings Explained: Nonconformity vs Observation (CQA)

19

230 - How Pharma Misses Critical Market Signals with Joe Luminiello

20

229 -Outsourcing Analytical Testing: What Sponsors Get Wrong in Combination Products

21

228 - ICH Q5 EXPLAINED: Why Regulators Treat Biologics Differently

22

227 - When Should You Open a CAPA? Triggers, Human Error, and Investigation Basics

23

226 - Navigating China NMPA Medical Device Requirements | Standards, GMP Updates, Agents & Classification

24

226 - ICH Q4 Explained: How Pharmacopeial Methods Are Accepted Across Regions

25

225 - ICH Q3A, Q3B, Q3C, Q3D and Q3E - EXPLAINED in 10 Minutes

26

224 - ICH Q2 Explained: What Analytical Validation Really Requires

27

223 - What’s Changing in ICH Q1 and What Isn’t: Understanding Stability Expectations

28

222 - How ICH Guidelines Are Organized: Understanding the Q, S, E, and M Series

29

221 - What Is ICH and Why It Matters

30

220 - Managing Oneself, Reflections and a New Series on ICH

31

219 - FDA PreCheck and the Future of Inspections: PAI to Pre-Readiness

32

218 - ICH Q13: Continuous Manufacturing EXPLAINED (Batch vs. Continuous)

33

217 - 5 Fixable Problems Holding Back Drug–Device Programs

34

216 - How UAE and Singapore Are Redefining Regulatory Innovation with Stephen O'Rourke

35

215 - Why Aren’t Technical People Leading Drug-Device Audits?

36

214 - The Best 5 Certifications for ANY Quality Career Path (CQE, Green Belt, CQA & More)

37

213 - From Generic Underdog to Billion‑Dollar Exit: How Usman Ahmed Built & Sold a Sterile Injectable Site

38

212 - What 6 of the World’s Biggest Companies Taught Him About Combination Products

39

211 - Inside FDA’s Office of Combination Products: History, PMOA, and What’s Next for Combination Products with Mark Kramer

40

210 - The 8 Roles You MUST Understand in Pharma & MedTech

41

210 - How AI Is Rewriting GMP: Smarter CAPA, PAT, DOE, and Continuous Yield

42

209 - ALCOA++ EXPLAINED | What Everyone Gets Wrong About Data Integrity with Monika Andraos

43

208 - How Drugs Are Designed, Targets, Phenotypes, and Structure Based Design

44

207 - What 99.999% Reliability Really Means

45

206 - Will AI Decide Your Next Drug/Device Approval?

46

205 - Why Less Than 20% of Companies Have Started Quality 4.0

47

204 - The Dictionary & Thesaurus of Combination Products (Finally Explained) with Susan Neadle

48

203 - Drug Delivery, Platforms, IP Battles, Supply Chain Risks with Jim Collins

49

202 - Becoming an Expert in the Work Nobody Wants to Do/Design, Risk, and the Messy Middle of Combination Products w/Joey Frechin

50

201 - Inside a $300M FDA Remediation, Lessons from Zimmer to EpiPen Warning Letters, 99.999% Reliability and Quality 4.0

51

200 - MedTech and Pharma After 200 Episodes…..

52

199 - How Modeling Can Cut in Half for Combination Products, V&V 40, and Cutting Dev Time with Mark Burchnall

53

198 - QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve Missed

54

197 - Quality Agreements Explained: How to Protect Yourself When Things Go Wrong

55

Combi Crumbs: Clinical Trials 101 – From Safety to Strategy

56

196 - How to Win Your First 90 Days in Pharma and MedTech

57

195 - Clinical Trial Design, Oncology Innovation & Decentralized Trials with Archana Sah

58

194 - Drug Delivery Innovation, Networking in Pharma, and Building a Career That Matters with Mike Denzer

59

193 - Bioengineering Grads: Here’s What Recruiters Actually Want to See in 2025

60

192 - What Is a Drug/Device Combination Product? (Non-Technical, Under 5 Minutes)

61

191 - If It’s Not ALCOA+, It Didn’t Happen: The Real Meaning of Data Integrity

62

190 - Harmony, Not Sameness: What Drug-Device Teams Keep Getting Wrong

63

189 - FDA, ISO, ICH, USP, PDA - What Are These Groups and Why Do They Matter?

64

188 – Certified Quality Auditor(CQA) and Audits in the Future

65

187 - Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained)

66

186 - 4 Ways to Future-Proof Your Career in Pharma, Medical Devices and BioTech

67

185 - ISO 10013, Document Control in Pharma & Devices: SOPs, Work Instructions, and RACI Done Right with Aaron Snyder

68

184 - Program Management in Pharma & Devices: Phase Gates, Risk Planning, and Project FMEAs Explained

69

183 - GxP Explained: A Complete Guide to Good Manufacturing, Clinical, Laboratory, and Distribution Practices for Regulated Products

70

182 - 7 Powerful Ways to Find Amazing Mentors in Medical Devices and Pharma

71

181 - Can Ampoule Drug Delivery Systems REVOLUTIONIZE the Industry?

72

180 - MIT Leadership Expert Reveals Management Secrets for Scientists!

73

179 - Quality is NOT Everyone’s Job—Why That’s a GOOD Thing

74

178 - CAPA Face-Off: Pharma vs. MedTech – Key Differences You Need to Know

75

177 - The GXPs That Run Pharma & Medical Devices: GMP, GDP, GCP, GLP, GVP, GAMP EXPLAINED

76

176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski

77

175 - Hearing Aid Innovations and Why Hearing Loss Is More Dangerous Than You Think with Bill Facteau

78

174 - How GLP-1s Like Ozempic & Wegovy Are Changing Pharma with Ben Locwin

79

173 - Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barriers in IVF & Women's

80

172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead

81

171 - Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or Small Molecules considered Combination Products?

82

170 - The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner)

83

169 - Should You Study Bioengineering in 2025? My Decade-Long Perspective

84

168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth

85

167 - Smart Pills, Digital Drug Delivery Systems, and How Technology is Reshaping Pharma and Healthcare with Timothy Aungst

86

166 - Sync or Sink: 3 Levels of Harmonization for Combination Product Success

87

165 - Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta New

88

164 - Tiny Particles, Big Impact: Breaking down USP 788 & USP 790

89

163 - ICH Q12, Established Conditions, Post-Approval Changes, PACMP's, and the Pharma Lifecycle

90

162 - Philip Crosby’s 5 Bad Beliefs About Quality (And How to Avoid Them)

91

161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination Products

92

160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED!

93

159 - Centralized, Decentralized & Federated Quality Models, McKinsey Study, and QA vs. QC with Ben Locwin

94

158 - 3 Years Straight of Drug/Device Podcasting, Guarding the Process, and the Future of the Show

95

157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura

96

156 - Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar

97

155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach

98

154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell

99

153 - USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio

100

152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh

101

151 - Primary Packaging/Container Closure Change Guidance, Post-Approval Changes, Sponsor/Supplier Relationships, Purchasing Controls and Tubular vs. Molded Glass with Fran Degrazio

102

150 - Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar

103

149 - Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, Loading, Automation, Refrigeration, Vacuum, Filtration, and Potent/Non-Aqueous Considerations with David Simoens

104

148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner

105

147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup

106

146 - Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water's Triple Point with David Simoens

107

145 - Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi

108

144 - Auto-Injectors, Pen Injectors, Challenges in Product Development, Sponsors and CDMO's with David DeSalvo

109

143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young

110

142 - Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin

111

141 - Lessons from the Life and Legacy of Quality Guru H. James Harrington (1929-2024)

112

140 - Medical Device & Diagnostics Cybersecurity, 3rd Party Software, SBOM's, Evaluating Skill and Mindset with Christian Espinosa

113

139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh

114

138 - Operations vs. Quality, KPI's, Management Controls, Process Improvement, Balancing Capability/Capacity and Improvement Culture with Larry Mager

115

137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens

116

136 - Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura

117

135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson

118

134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch

119

133 - A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell

120

132 - IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner

121

131 - Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer

122

130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder

123

129 - Combination Products, Infusion Pumps and Recalls, Responding to Health Disasters with Public Health Service, and FDA Rule-making Process with Captain Alan Stevens

124

128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture

125

127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal

126

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

127

125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh

128

124 - 5 Steps to Becoming a Phenom Quality Pro with Andy Robertson

129

123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker

130

122 - Intricacies of Joint Audits, Rx360, Supply Chain Security, and Networking in Pharma/MedTech with Jim Fries

131

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

132

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

133

119 - What are the basics of Clean Rooms, RABS and Isolators in ISO14644 and EU Annex I? with David Simoens

134

118 - What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead

135

117 - Post Market Surveillance, Safety Reporting, Databases, Platforms Health Hazards Assessments and Product Responsibilities with Khaudeja Bano

136

116 - Gas Sterilization, ETO, Pre-Conditioning, Materials, Different Gases, Bioburden, Validation, and Safety with Jeanne Moldenhauer

137

115 - Bottle of Lies, Generic Drugs Quality, Ranbaxy, Audits, and Inspiring Quality Pros with NYT Best-Selling Author, Katherine Eban

138

114 - Irradiation Sterilization, Gamma, X-Ray, E-Beam, Dosimeters, and Combination Products with Jeanne Moldenhauer

139

113 - Pharma/MedTech Market, Why Good People Leave, Finding Motivation, Onshoring in Pharma and Motivation with Ira Mann

140

112 - Steam Sterilization, Moist/Dry Heat, Biological Indicators, Cycle Development, Validation and Parametric with Release with Jeanne Moldenhauer

141

111 - 7 Books to level up for MedTech, BioTech and Combination Product Professionals with Subhi Saadeh

142

110 - CXO/CDMO in the future, Supply Chain, Reverse Knowledge Transfer, Trust and Fashionisity with Ben Locwin

143

109 - Protecting Patients at All Costs, Being a CQO in Big Pharma, Supply Chain Security and Generic Drugs with Martin Van Trieste

144

108 - Clinical Interpretation, Non-Clinical and Clinical CTD Modules 4 & 5, Pre-IND/IND and Dossiers with Margaret Jenkins

145

107 - Distilling Decades of MedTech Data, Generative AI, and Doing Without Tribal Knowledge with Michelle Wu

146

106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott

147

106 - Temperature Mapping, Validation, Data Loggers, Cold Chain, Monitoring and Commissioning with Nathan Roman

148

105 - Triathlon: The Combination Products of Sport, 8 Lessons from Ironman Chatanooga and 100 Episodes with Subhi Saadeh

149

104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre-IND HF Studies with Sara McNew

150

103 - Prescription Reconciliation, Medication Error Reduction, Automated Home Care, Assisted Robotics, Patient Behavioral Monitoring, and the future of Clinical Trials with Charles Gellman

151

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

152

101 - Micro-Array Patches, Combination Products in Australia, Differences between TGA and RoW, Novel Delivery Systems, and Clinical Trials with Megan Polidano

153

100 - PQMCoach, Our First Recording, Quality (Big Q/little q), Why Predictive Quality Management, and Communicating Quality with Larry Mager

154

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

155

098 - MedTech vs. Aerospace Risk Management, AFAP vs. ALARP/ALARA, Quantifying Benefit, Risk Control Measures, and Risk Management Reports with Bijan Elahi

156

097 - Predictive Quality, Business Process Capabilities, 3 Lines of Quality Defense, TOC, COSO and Business Risk with Larry Mager

157

096 - Pharma Waste Management, Sustainability, What Happens to Sharps, Disposal and Zero Waste with Heather Johnson

158

095 - How FMEA fits into ISO14971, Probabilities, Severity of Harm, RPN's, pFMEA's and making it simpler with Naveen Agarwal

159

094 - Connected Combination Products, Product Traceability, Regulating New Products, Pre-Determined Changes and AI/ML with Rumi Young

160

093 - Combination Products Handbook Part 2: Supplier Management, Drug/Device Analytical Testing, Biologics, Digital/Connected Health and Changing Regulatory Landscape with Susan Neadle

161

092 - Putting it all together: Drug cGMP’s 210/211/ICH and Device QMS 820/ISO13485 with Aaron Snyder

162

091 - Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan Neadle

163

090 - Software Validation, Automation, No-Code Quality Tools and QMS with Harsh Thakkar

164

089 - Talking HealthTech Podcast, Consistency, Australian Innovation in HealthTech, Content, and Community with Peter Birch

165

088 - Production Part Approval Process(PPAP) with Subhi Saadeh

166

087 - From Crime Reporting to Regulatory Affairs and On/Off The Record with Ferdous Al-Faruque

167

086 - Elastomers - Stopper and Plunger Manufacturing, Processing and USP 381/382 with ⁠Fran DeGrazio⁠ 

168

085 - Digital Innovation, Proteomics, Core & Non-Core Innovation, Consulting after Academia, Democratizing Access and Clinical Trials with Jacob Laprote

169

084 - Drug Discovery, Candidate Selection, Pre-Clinical Development, IND Submissions, Administration Route Selection, TPP and Toxicology with Marta New

170

083 - Holistic Approach to Container Closure Integrity, Capping/Crimping, RSF, and Annex I/USP 1207 Requirements with Derek Duncan

171

082 - CTD Structure for Combination Products, US vs. EU Submissions and Regulatory R&R with Niedre Heckman

172

081 - ISO TC 84, ISO11608, Committee Work and Advancing the State of the Art with Bob Nesbitt

173

080 - 9 CCI Tests in 10 Minutes, Probabilistic vs. Deterministic, and CCI vs. Permeation with Derek Duncan

174

079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young

175

078 - Prevention is Not New, Incentives in Health Care, and Integrated Combination Products with Ramin Rafiei

176

077 - 8 Databases and How To Use Them with Michelle Lott

177

076 - GMP Training, Competence, Human Error and Mentorship with Joanna Gallant

178

075 - Shortages, Pricing, Mastering New Skills, and Building Deep Understanding with Ben Locwin

179

074 - Article 117, EU MDR extension, Notified Body Opinions, Timing and Interaction with Christiana Hoffman

180

073 - Anatomy of a Hazard, Clifton Ericcson, ISO 14971/24971 Risk Management with Naveen Agarwal

181

072 - OXO PFS, Drug/Device Usability, Toothbrushes for Children, Epicurious Series and Baseball with Dan Formosa

182

071 - Steel Industry to MedTech & Important Quality Systems with Etienne Nichols

183

070 - The First Auto-Injectors, ISO-11608 History, and Managing Product with Paul Jansen

184

069 - EU MDR Extension with Michelle Lott

185

068 - Benefit/Risk Ratios, PRRC, and Mythical Medical with David Rutledge

186

067 - mRNA, Flu Vaccines, Good Presentations, and Non-Linear Career Paths with Jane M. True

187

066 -Scientist to CSO, Learning QA/RA & Marketing, and Saying Yes to Oppurtunities with Fran DeGrazio

188

065 - "8 Quality Lessons from Losing 100 Lbs " with Subhi Saadeh

189

064 - Pharma and Medical Device Development Processes, DFSS and Design Reviews with Skip Creveling

190

063 - Combination Products Regulatory, Going Wide, and Patient Impact with Niedre Heckman

191

062 - Reimbursement in Europe, Access, Rebates, and Negotiation with Stefan Walzer

192

061 - Taguchi, Pugh, DFSS, Robust Design and Tolerancing with Skip Creveling

193

060 - Why People Leave, Starting Elemed and Trusted Advisory with Elena Kyria

194

059 - Literature Review, EU MDR CER’s, and Being Problem Driven with Ethan Drower

195

058 - PMSR Globally, Different Clinical Roles and Risk Management with Khaudeja Bano

196

057 - Conferences, Expos, LinkedIn and Launching a Podcast with Rizwan Chaudhrey

197

056 - "Non-Promotional Compliance" with Darshan Kulkarni

198

055 - "Critical Tasks and Knowledge Tasks" with Alexandra Benbadis

199

054 - "EUDAMED" with Richard Houlihan

200

053 - "Duct Tape and Bubble Gum" with Chris Tsai

201

052 - “All Work is Process” with Larry Mager

202

051 - "EU MDR" with Bassil Akra

203

050 - "When No One is Listening" with James Somauroo

204

049 - "What Does the Data Say?" with Shannon Hoste

205

048 - "Materials" with Hsinjin Yang

206

047 - "Truthful Not Misleading" with Darshan Kulkarni

207

046 - "Inflation Reduction Act" with Sarfaraz Niazi

208

045 - "Combination Products around the Globe" with Susan Neadle

209

044 -“Market Access” with Kasem Akhras

210

043 - “Half Knowledge Can Hurt” with Shadeed Salam

211

042 - “Reproducible within Limits”

212

041 - “Health Citizenship” with Jane Sarasohn Kahn

213

040 - “Good Science is Good Science” with Ben Locwin

214

039 - "The Camera Didn't Make the Artist Obsolete" with John Nosta

215

038 - "Clinical Trials" with Dan Sfera

216

037 - Reflections #1 - (Episodes 001-25)

217

036 - "Those Moments Keep You Grounded" with Yousef Arman

218

035 - “Safety is Safety” with Khaudeja Bano

219

034 - "Agent" with Mitch Robbins

220

033 - "Specialization" with Erik Barkley

221

032 - “Quality is Free”

222

031 - "The Five Stages Of Regulatory Grief" with Michelle Lott

223

030 - "Why Don't I Try?" with Marc Koska

224

029 - "Purpose" with Marla Phillips

225

028 - "How Much Does Poor Quality Cost?" with H. James Harrington

226

027 - "Become a Historian of the Problem" with Duane Mancini

227

026 - "Quality" with H. James Harrington

228

025 - “The Frying Pan to the Fire” with Edwin Bills

229

024 - "Operating Under Constraints "with Naveen Agarwal

230

023 - "The Best is Yet to Come" with David Albert

231

022 - "What Chapter are you in?" with Susan Neadle

232

021 - "Options" with Karandeep Singh Badwal

233

020- "The Right Words" with Kathy Walsh

234

019 - "Carrying The Bag" with Omar M Khateeb

235

018 - "The Optimist Plans for Forever" - with Sarfaraz Niazi

236

017 - "Feet First" with Ahmed Zobi

237

016 - "Be More Specific" with Joe Hage

238

015 - "Would You Use it on a Family Member?" with Monir El Azzouzi

239

014C - "The Final P: People" with Larry Mager

240

014B - "The Second P: Process" with Larry Mager

241

014A - "The First P: Product" with Larry Mager

242

013 - “Big Rocks and Little Rocks” with Jumha Abu-Razeq

243

012 - "Asking then Seeing" with Sara Waxberg Mcnew

244

011 - “Long Story Short” with Margot Leitman

245

010 - "Don't Make Assumptions" with David Simoens

246

009 - “Cutting Through the Noise” with Charles Ventura

247

008 - "Follow the Opportunity" with Marta New

248

007 - "Beyond The Obvious" with Miiri Kotche

249

006 - “The Courage to Start” with John Bingham

250

005 - “Compassionate Product Development” with Cameron Jones

251

004 - “Until They Know How Much You Care” with Andy Robertson

252

003 - “Standard Understanding” with Mark Swanson

253

002 - “Seeing David in the Stone: Predictive Quality Management” with Larry Mager

254

001 - “Learning Never Exhausts the Mind” with Rick Doe