All Episodes
The Life Science Rundown — 81 episodes
Managing AI Risk Across Global Quality Systems
The Case for Engaging Regulatory Early
Why Quality and R&D Default to Conflict (and How to Fix It)
Leading Through the AI Shift with ASQ's CEO Sid Bhatnagar
Why Your CAPA System Isn't Driving Improvement (and How to Fix It)
TerSera's VP of Quality on the Audit Risk Hiding Inside Your Own Procedures
What Auditors Are Actually Looking For — and the Psychology Behind How They Find It
Why Kidney Disease Innovation Is a Tale of Two Cities — and What It Would Take to Change That
Syncing Global Regulatory Filings Across FDA, EMA, and PMDA with AJ Acker
Navigating Regulatory Leadership Across Large and Small Life Science with Tammy Sarnelli
Getting Data Governance for Regulatory Submissions Right Before AI Gets it Wrong with Cary Smithson
Building Resilient Biotech Teams in Cell and Gene Therapy with Nelly Viseux
Building Phase-Appropriate Quality from Preclinical to Commercial with Jackie Klecker
Preparing the Workforce That Will Shape Pharma’s Future with ISPE President & CEO Mike Martin
How to Build (and Sustain) a Quality-Centric Culture with Chris Masterson
From Molecule to Market: A Commercial-Readiness Playbook for Biotechs with Carlos Carrillo
How Regulators Are Bringing AI Into Review (Without Losing Trust) with Maria Vassileva
A Playbook for FDA Inspections and Remediation with Jeff Hines
Leading Cross-Functional Teams from Concept to Commercialization with Marwan Fathallah
Breaking Down FDA’s E21 Draft Guidance: Including Pregnant and Breastfeeding Women in Clinical Trials with Regina Atim
Staying Ready for the FDA (When Inspections Are Less Predictable)
Building the Next-Gen Lab: AI in a GLP Environment with Catherine Lunardi
How to Build High-Performing Quality Teams with Marcus Gesner
The 4 Cs of MedTech Leadership with Sean Gallimore
The Power (and Pitfalls) of Real-World Evidence with Dr. Manfred Stapff
Quality Is Not a Cost Center—It’s a Culture (with Dr. Kimberly Garko)
From Cost Center to Value Driver: Rethinking Quality in the Life Sciences with Marcia Baroni
Managing Royalties in Biotech, Pharma, and Medtech with David Marlin
GMP Compliance in 503B Compounding Pharmacies with Jesse Gillikan
A Smarter Approach to Supplier Quality Audits with Thermo Fisher's David Festa
Mastering FDA and EMA Regulatory Meetings with Ashley Preston
Working with Chinese CROs: Benefits, Risks, and Best Practices with Harri Järveläinen
The Smart Way to Adopt AI in Clinical Trials and Regulatory Affairs with Keith Parent
Demystifying AI in Life Sciences Supply Chain with Jennifer Chew
Streamlining Promotional Reviews in the Life Sciences with Annalise Ludtke
Navigating Supplier Audits in Japan with Derek Wessman
Small Lots, Big Risks: Rethinking Statistical Sampling in Biopharma
Quality Metrics that Matter with Kimberly Wallbank
Applying AI in the Life Sciences with MasterControl's Matt Lowe
Navigating Challenges in Raw Material and Finished Product Storage with Eric Busenburg
Building and Leading Effective Quality Assurance Teams with Aaron Snyder
The Pharma Startup Playbook: Advice from the Field with Taggart McGurrin
Navigating FDA Regulations for SaMD AI and Machine Learning with Adam Foresman
Crafting Quality Systems for Each Phase of Drug Development with Carlos Yuraszeck
Leading Through Transition: Strategic Insights from Novartis's Front Lines
Real Talk on Remote Leadership with Nick Klingensmith
Audit and FDA Inspection Readiness Best Practices with Divya Gowdar
Mastering the TMF: Ensuring GCP Compliance and Inspection Readiness with Donna Dorozinsky
The Startup's Guide to Setting Up Cell Therapy Manufacturing: Navigating Regulations, Resources and Timelines
A Blueprint for Quality Culture with Vincent Cafiso
An FDA Inspection Survival Guide with Jonathan Wacks
Clinical Data Standards in Focus: SDTM Compliance with Sunil Gupta
The Link Between Quality Culture and QA Communication Pathways with David Marks
Mastering Medical Device Supplier Management with Paul Hakamaki
Recent FDA Enforcement Trends with George Toscano
Growing Your Career in RA/QA with Jessica Smith Beaver, PhD
Drug Delivery System Innovation and Leadership with Steve Knowles
Motivating Technical Teams in the Life Sciences: A Conversation with Rick Beatty
Cross-Cultural Pharma: Mike Martin's Experiences from Puerto Rico to China
Courageous Leadership to Reinvent Our Healthcare System
The Critical Role of 'Hyper-Targeting' in Rare Disease Drug Development
A Journey into Life Sciences Investment: Strategies, Challenges, and Opportunities with Sal Buscemi
Navigating Risk Management in Medical Devices with Brian Dense
The DEA, FDA & Controlled Substances: An Insider's Perspective with Former DEA Agent Dennis Wichern
A Deep Dive into Medical Device Regulatory Strategy with Regulatory Attorney Christine P. Bump
Lessons from a Medtech Entrepreneur: Ram Konduru on Fostering Teamwork and Personal Growth in Leadership
Unlocking Effective Leadership: A Conversation with MetaComet Systems President, David Marlin
Leadership, Management, and Enhancing Quality of Life: A Conversation with Dan Barker, CEO of Wikimotive
Navigating the 510(k) Process: A Q&A with Regulatory Consultant, Trey Thorsen, MS, RAC
The Future of Life Science Talent Acquisition: Securing In-Demand Skills in a Competitive Market
FDA Revives Its Proposed Quality Metrics Program for Pharma
Inspection Alternatives Are Driving More FDA Enforcement Actions: What It Means for Industry
FDA's Domestic Biopharma Inspections Return to Normal
Quality Management Review: Benchmarking Quantitatively!
Addressing FDA's Inspection Backlog with Mary Denigan-Macauley, GAO's Director of Health Care
FDA's Fraudulent Products Task Force and Operation Quack Hack Battle COVID Vaccine Scams
What to Expect for the FDA's Regulation of Medical Devices & Digital Health Under the Biden Administration
Clinical Outsourcing & Insourcing: Selecting the Right Model or Mix
What RA/QA/Clinical Leaders Should Expect From the FDA in 2021
Inside FDA Pre-Approval Inspections with Former FDA Investigator, Christopher Smith
A Look at FDA's Pandemic Inspections Q&A Guidance