The Life Science Rundown

0
Life Sciences #129

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.

More
Recent Episodes
  • A Smarter Approach to Supplier Quality Audits with Thermo Fisher's David Festa
    Feb 28, 2025 – 00:41:42
  • Mastering FDA and EMA Regulatory Meetings with Ashley Preston
    Feb 10, 2025 – 00:40:45
  • Working with Chinese CROs: Benefits, Risks, and Best Practices with Harri Järveläinen
    Feb 5, 2025 – 00:38:08
  • The Smart Way to Adopt AI in Clinical Trials and Regulatory Affairs with Keith Parent
    Nov 22, 2024 – 00:38:24
  • Demystifying AI in Life Sciences Supply Chain with Jennifer Chew
    Nov 14, 2024 – 00:39:10
  • Streamlining Promotional Reviews in the Life Sciences with Annalise Ludtke
    Oct 25, 2024 – 00:35:28
  • Navigating Supplier Audits in Japan with Derek Wessman
    Oct 17, 2024 – 00:27:40
  • Small Lots, Big Risks: Rethinking Statistical Sampling in Biopharma
    Aug 29, 2024 – 00:18:54
  • Quality Metrics that Matter with Kimberly Wallbank
    Aug 19, 2024 – 00:41:35
  • Applying AI in the Life Sciences with MasterControl's Matt Lowe
    Jul 15, 2024 – 00:30:35
  • Navigating Challenges in Raw Material and Finished Product Storage with Eric Busenburg
    Jul 3, 2024 – 00:32:55
  • Building and Leading Effective Quality Assurance Teams with Aaron Snyder
    Jun 20, 2024 – 00:55:00
  • The Pharma Startup Playbook: Advice from the Field with Taggart McGurrin
    Jun 18, 2024 – 00:50:33
  • Navigating FDA Regulations for SaMD AI and Machine Learning with Adam Foresman
    May 15, 2024 – 00:28:37
  • Crafting Quality Systems for Each Phase of Drug Development with Carlos Yuraszeck
    Apr 30, 2024 – 00:18:36
  • Leading Through Transition: Strategic Insights from Novartis's Front Lines
    Apr 1, 2024 – 00:47:25
  • Real Talk on Remote Leadership with Nick Klingensmith
    Mar 29, 2024 – 00:44:47
  • Audit and FDA Inspection Readiness Best Practices with Divya Gowdar
    Feb 19, 2024 – 00:27:36
  • Mastering the TMF: Ensuring GCP Compliance and Inspection Readiness with Donna Dorozinsky
    Feb 5, 2024 – 00:17:04
  • The Startup's Guide to Setting Up Cell Therapy Manufacturing: Navigating Regulations, Resources and Timelines
    Jan 18, 2024 – 00:40:15
  • A Blueprint for Quality Culture with Vincent Cafiso
    Dec 19, 2023 – 00:53:38
  • An FDA Inspection Survival Guide with Jonathan Wacks
    Dec 14, 2023 – 00:52:14
  • Clinical Data Standards in Focus: SDTM Compliance with Sunil Gupta
    Dec 12, 2023 – 00:21:26
  • The Link Between Quality Culture and QA Communication Pathways with David Marks
    Nov 15, 2023 – 01:08:52
  • Mastering Medical Device Supplier Management with Paul Hakamaki
    Nov 9, 2023 – 00:45:56
  • Recent FDA Enforcement Trends with George Toscano
    Nov 3, 2023 – 00:37:30
  • Growing Your Career in RA/QA with Jessica Smith Beaver, PhD
    Nov 1, 2023 – 00:53:40
  • Drug Delivery System Innovation and Leadership with Steve Knowles
    Oct 20, 2023 – 00:39:26
  • Motivating Technical Teams in the Life Sciences: A Conversation with Rick Beatty
    Oct 9, 2023 – 00:52:32
  • Cross-Cultural Pharma: Mike Martin's Experiences from Puerto Rico to China
    Aug 14, 2023 – 00:40:30
  • Courageous Leadership to Reinvent Our Healthcare System
    Jul 27, 2023 – 00:49:06
  • The Critical Role of 'Hyper-Targeting' in Rare Disease Drug Development
    Jul 14, 2023 – 00:30:03
  • A Journey into Life Sciences Investment: Strategies, Challenges, and Opportunities with Sal Buscemi
    Jun 1, 2023 – 00:36:34
  • Navigating Risk Management in Medical Devices with Brian Dense
    May 15, 2023 – 00:35:40
  • The DEA, FDA & Controlled Substances: An Insider's Perspective with Former DEA Agent Dennis Wichern
    Apr 26, 2023 – 00:30:27
  • A Deep Dive into Medical Device Regulatory Strategy with Regulatory Attorney Christine P. Bump
    Apr 11, 2023 – 00:38:07
  • Lessons from a Medtech Entrepreneur: Ram Konduru on Fostering Teamwork and Personal Growth in Leadership
    Apr 3, 2023 – 00:29:24
  • Unlocking Effective Leadership: A Conversation with MetaComet Systems President, David Marlin
    Mar 24, 2023 – 00:36:04
  • Leadership, Management, and Enhancing Quality of Life: A Conversation with Dan Barker, CEO of Wikimotive
    Mar 9, 2023 – 00:30:58
  • Navigating the 510(k) Process: A Q&A with Regulatory Consultant, Trey Thorsen, MS, RAC
    Feb 9, 2023 – 00:22:32
  • The Future of Life Science Talent Acquisition: Securing In-Demand Skills in a Competitive Market
    Nov 21, 2022 – 00:25:44
  • FDA Revives Its Proposed Quality Metrics Program for Pharma
    Apr 18, 2022 – 00:07:37
  • Inspection Alternatives Are Driving More FDA Enforcement Actions: What It Means for Industry
    Feb 14, 2022 – 00:21:45
  • FDA's Domestic Biopharma Inspections Return to Normal
    Aug 5, 2021 – 00:08:33
  • Quality Management Review: Benchmarking Quantitatively!
    Jul 2, 2021 – 00:26:36
  • Addressing FDA's Inspection Backlog with Mary Denigan-Macauley, GAO's Director of Health Care
    Jun 3, 2021 – 00:31:08
  • FDA's Fraudulent Products Task Force and Operation Quack Hack Battle COVID Vaccine Scams
    Mar 9, 2021 – 00:08:02
  • What to Expect for the FDA's Regulation of Medical Devices & Digital Health Under the Biden Administration
    Jan 28, 2021 – 00:08:59
  • Clinical Outsourcing & Insourcing: Selecting the Right Model or Mix
    Jan 11, 2021 – 00:32:57
  • What RA/QA/Clinical Leaders Should Expect From the FDA in 2021
    Dec 16, 2020 – 00:43:07
Recent Reviews
Similar Podcasts
Up First from NPR
Disclaimer: The podcast and artwork on this page are property of the podcast owner, and not endorsed by UP.audio.