Episodes
139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh
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138 - Operations vs. Quality, KPI's, Management Controls, Process Improvement, Balancing Capability/Capacity and Improvement Culture with Larry Mager
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137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens
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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
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135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson
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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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133 - A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell
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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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131 - Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer
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130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder
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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
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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
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127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal
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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
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125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh
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124 - 5 Steps to Becoming a Phenom Quality Pro with Andy Robertson
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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
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122 - Intricacies of Joint Audits, Rx360, Supply Chain Security, Networking,
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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
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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
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119 - What are the basics of Clean Rooms, RABS and Isolators in ISO14644 and EU Annex I? with David Simoens
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118 - What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead
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117 - Post Market Surveillance, Safety Reporting, Databases, Platforms Health Hazards Assessments and Product Responsibilities with Khaudeja Bano
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