The Life Science Rundown
By The FDA Group
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Category: Life Sciences
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Episodes: 76
Description
The Life Science Rundown is a podcast for life science professionals hosted by The FDA Group. We dive deep into topics across the RA/QA/Clinical space, covering news, exploring trends, and picking the brains of expert guests.
| Episode | Date |
|---|---|
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TerSera's VP of Quality on the Audit Risk Hiding Inside Your Own Procedures
|
May 18, 2026 |
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What Auditors Are Actually Looking For — and the Psychology Behind How They Find It
|
Apr 28, 2026 |
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Why Kidney Disease Innovation Is a Tale of Two Cities — and What It Would Take to Change That
|
Apr 10, 2026 |
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Syncing Global Regulatory Filings Across FDA, EMA, and PMDA with AJ Acker
|
Mar 30, 2026 |
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Navigating Regulatory Leadership Across Large and Small Life Science with Tammy Sarnelli
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Mar 19, 2026 |
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Getting Data Governance for Regulatory Submissions Right Before AI Gets it Wrong with Cary Smithson
|
Mar 05, 2026 |
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Building Resilient Biotech Teams in Cell and Gene Therapy with Nelly Viseux
|
Feb 09, 2026 |
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Building Phase-Appropriate Quality from Preclinical to Commercial with Jackie Klecker
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Jan 12, 2026 |
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Preparing the Workforce That Will Shape Pharma’s Future with ISPE President & CEO Mike Martin
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Jan 06, 2026 |
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How to Build (and Sustain) a Quality-Centric Culture with Chris Masterson
|
Dec 09, 2025 |
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From Molecule to Market: A Commercial-Readiness Playbook for Biotechs with Carlos Carrillo
|
Dec 02, 2025 |
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How Regulators Are Bringing AI Into Review (Without Losing Trust) with Maria Vassileva
|
Nov 17, 2025 |
|
A Playbook for FDA Inspections and Remediation with Jeff Hines
|
Oct 16, 2025 |
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Leading Cross-Functional Teams from Concept to Commercialization with Marwan Fathallah
|
Oct 06, 2025 |
|
Breaking Down FDA’s E21 Draft Guidance: Including Pregnant and Breastfeeding Women in Clinical Trials with Regina Atim
|
Sep 29, 2025 |
|
Staying Ready for the FDA (When Inspections Are Less Predictable)
|
Sep 19, 2025 |
|
Building the Next-Gen Lab: AI in a GLP Environment with Catherine Lunardi
|
Sep 19, 2025 |
|
How to Build High-Performing Quality Teams with Marcus Gesner
|
Sep 08, 2025 |
|
The 4 Cs of MedTech Leadership with Sean Gallimore
|
Aug 18, 2025 |
|
The Power (and Pitfalls) of Real-World Evidence with Dr. Manfred Stapff
|
Jul 28, 2025 |
|
Quality Is Not a Cost Center—It’s a Culture (with Dr. Kimberly Garko)
|
Jul 15, 2025 |
|
From Cost Center to Value Driver: Rethinking Quality in the Life Sciences with Marcia Baroni
|
Jul 08, 2025 |
|
Managing Royalties in Biotech, Pharma, and Medtech with David Marlin
|
Jun 09, 2025 |
|
GMP Compliance in 503B Compounding Pharmacies with Jesse Gillikan
|
May 20, 2025 |
|
A Smarter Approach to Supplier Quality Audits with Thermo Fisher's David Festa
|
Feb 28, 2025 |
|
Mastering FDA and EMA Regulatory Meetings with Ashley Preston
|
Feb 10, 2025 |
|
Working with Chinese CROs: Benefits, Risks, and Best Practices with Harri Järveläinen
|
Feb 05, 2025 |
|
The Smart Way to Adopt AI in Clinical Trials and Regulatory Affairs with Keith Parent
|
Nov 22, 2024 |
|
Demystifying AI in Life Sciences Supply Chain with Jennifer Chew
|
Nov 14, 2024 |
|
Streamlining Promotional Reviews in the Life Sciences with Annalise Ludtke
|
Oct 25, 2024 |
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Navigating Supplier Audits in Japan with Derek Wessman
|
Oct 17, 2024 |
|
Small Lots, Big Risks: Rethinking Statistical Sampling in Biopharma
|
Aug 29, 2024 |
|
Quality Metrics that Matter with Kimberly Wallbank
|
Aug 19, 2024 |
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Applying AI in the Life Sciences with MasterControl's Matt Lowe
|
Jul 15, 2024 |
|
Navigating Challenges in Raw Material and Finished Product Storage with Eric Busenburg
|
Jul 03, 2024 |
|
Building and Leading Effective Quality Assurance Teams with Aaron Snyder
|
Jun 20, 2024 |
|
The Pharma Startup Playbook: Advice from the Field with Taggart McGurrin
|
Jun 18, 2024 |
|
Navigating FDA Regulations for SaMD AI and Machine Learning with Adam Foresman
|
May 15, 2024 |
|
Crafting Quality Systems for Each Phase of Drug Development with Carlos Yuraszeck
|
Apr 30, 2024 |
|
Leading Through Transition: Strategic Insights from Novartis's Front Lines
|
Apr 01, 2024 |
|
Real Talk on Remote Leadership with Nick Klingensmith
|
Mar 29, 2024 |
|
Audit and FDA Inspection Readiness Best Practices with Divya Gowdar
|
Feb 19, 2024 |
|
Mastering the TMF: Ensuring GCP Compliance and Inspection Readiness with Donna Dorozinsky
|
Feb 05, 2024 |
|
The Startup's Guide to Setting Up Cell Therapy Manufacturing: Navigating Regulations, Resources and Timelines
|
Jan 18, 2024 |
|
A Blueprint for Quality Culture with Vincent Cafiso
|
Dec 19, 2023 |
|
An FDA Inspection Survival Guide with Jonathan Wacks
|
Dec 14, 2023 |
|
Clinical Data Standards in Focus: SDTM Compliance with Sunil Gupta
|
Dec 12, 2023 |
|
The Link Between Quality Culture and QA Communication Pathways with David Marks
|
Nov 15, 2023 |
|
Mastering Medical Device Supplier Management with Paul Hakamaki
|
Nov 09, 2023 |
|
Recent FDA Enforcement Trends with George Toscano
|
Nov 03, 2023 |
|
Growing Your Career in RA/QA with Jessica Smith Beaver, PhD
|
Nov 01, 2023 |
|
Drug Delivery System Innovation and Leadership with Steve Knowles
|
Oct 20, 2023 |
|
Motivating Technical Teams in the Life Sciences: A Conversation with Rick Beatty
|
Oct 09, 2023 |
|
Cross-Cultural Pharma: Mike Martin's Experiences from Puerto Rico to China
|
Aug 14, 2023 |
|
Courageous Leadership to Reinvent Our Healthcare System
|
Jul 27, 2023 |
|
The Critical Role of 'Hyper-Targeting' in Rare Disease Drug Development
|
Jul 14, 2023 |
|
A Journey into Life Sciences Investment: Strategies, Challenges, and Opportunities with Sal Buscemi
|
Jun 01, 2023 |
|
Navigating Risk Management in Medical Devices with Brian Dense
|
May 15, 2023 |
|
The DEA, FDA & Controlled Substances: An Insider's Perspective with Former DEA Agent Dennis Wichern
|
Apr 26, 2023 |
|
A Deep Dive into Medical Device Regulatory Strategy with Regulatory Attorney Christine P. Bump
|
Apr 11, 2023 |
|
Lessons from a Medtech Entrepreneur: Ram Konduru on Fostering Teamwork and Personal Growth in Leadership
|
Apr 03, 2023 |
|
Unlocking Effective Leadership: A Conversation with MetaComet Systems President, David Marlin
|
Mar 24, 2023 |
|
Leadership, Management, and Enhancing Quality of Life: A Conversation with Dan Barker, CEO of Wikimotive
|
Mar 09, 2023 |
|
Navigating the 510(k) Process: A Q&A with Regulatory Consultant, Trey Thorsen, MS, RAC
|
Feb 09, 2023 |
|
The Future of Life Science Talent Acquisition: Securing In-Demand Skills in a Competitive Market
|
Nov 21, 2022 |
|
FDA Revives Its Proposed Quality Metrics Program for Pharma
|
Apr 18, 2022 |
|
Inspection Alternatives Are Driving More FDA Enforcement Actions: What It Means for Industry
|
Feb 14, 2022 |
|
FDA's Domestic Biopharma Inspections Return to Normal
|
Aug 05, 2021 |
|
Quality Management Review: Benchmarking Quantitatively!
|
Jul 02, 2021 |
|
Addressing FDA's Inspection Backlog with Mary Denigan-Macauley, GAO's Director of Health Care
|
Jun 03, 2021 |
|
FDA's Fraudulent Products Task Force and Operation Quack Hack Battle COVID Vaccine Scams
|
Mar 09, 2021 |
|
What to Expect for the FDA's Regulation of Medical Devices & Digital Health Under the Biden Administration
|
Jan 28, 2021 |
|
Clinical Outsourcing & Insourcing: Selecting the Right Model or Mix
|
Jan 11, 2021 |
|
What RA/QA/Clinical Leaders Should Expect From the FDA in 2021
|
Dec 16, 2020 |
|
Inside FDA Pre-Approval Inspections with Former FDA Investigator, Christopher Smith
|
Nov 12, 2020 |
|
A Look at FDA's Pandemic Inspections Q&A Guidance
|
Nov 12, 2020 |