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All 40 episodes by series. Open a series to see each one.
PublishedReleasingPlanned
- Industry · GMP Pharma Quality
- GMP Concepts | Pharmaceutical Quality System, Explained10-24PublishedGMP Concepts | Pharmaceutical Quality System, Explained | 2026-10-24 | Published
- GMP Concepts | Quality Risk Management10-30PublishedGMP Concepts | Quality Risk Management | 2026-10-30 | Published
- GMP Concepts | Documentation, Explained Once and for All11-02PublishedGMP Concepts | Documentation, Explained Once and for All | 2026-11-02 | Published
- GMP Concepts｜Computerized Systems, Explained in One Go10-19PublishedGMP Concepts｜Computerized Systems, Explained in One Go | 2026-10-19 | Published
- GMP Concepts | Qualification and Validation, Explained11-05PublishedGMP Concepts | Qualification and Validation, Explained | 2026-11-05 | Published
- GMP Concepts | Personnel11-08PublishedGMP Concepts | Personnel | 2026-11-08 | Published
- GMP Concepts | Premises and Equipment11-111 dayGMP Concepts | Premises and Equipment | 2026-11-11 | 1 day
- GMP Concepts | Production11-144 daysGMP Concepts | Production | 2026-11-14 | 4 days
- GMP Concepts | Quality Control11-177 daysGMP Concepts | Quality Control | 2026-11-17 | 7 days
- GMP Concepts | Sterile Products (1): Contamination Control and Cleanrooms11-2010 daysGMP Concepts | Sterile Products (1): Contamination Control and Cleanrooms | 2026-11-20 | 10 days
- GMP Concepts | Sterile Products (2): Aseptic Process Simulation and Environmental Monitoring11-2313 daysGMP Concepts | Sterile Products (2): Aseptic Process Simulation and Environmental Monitoring | 2026-11-23 | 13 days
- GMP Concepts | Authorised Person and Batch Release11-2616 daysGMP Concepts | Authorised Person and Batch Release | 2026-11-26 | 16 days
- GMP Concepts | Reference and Retention Samples11-2919 daysGMP Concepts | Reference and Retention Samples | 2026-11-29 | 19 days
- GMP Concepts | Outsourced Activities12-0222 daysGMP Concepts | Outsourced Activities | 2026-12-02 | 22 days
- GMP Concepts | Complaints and Product Recall12-0525 daysGMP Concepts | Complaints and Product Recall | 2026-12-05 | 25 days
- GMP Concepts | Self-Inspection12-0828 daysGMP Concepts | Self-Inspection | 2026-12-08 | 28 days
- GMP Concepts | Change Control, Deviations and CAPA12-1131 daysGMP Concepts | Change Control, Deviations and CAPA | 2026-12-11 | 31 days
- GMP Concepts | Active Pharmaceutical Ingredients (Part II)12-1434 daysGMP Concepts | Active Pharmaceutical Ingredients (Part II) | 2026-12-14 | 34 days
- GMP Concepts | Biologics and ATMPs12-1737 daysGMP Concepts | Biologics and ATMPs | 2026-12-17 | 37 days
- PIC/S, FDA and NMPA: Three GMP Systems Compared12-2040 daysPIC/S, FDA and NMPA: Three GMP Systems Compared | 2026-12-20 | 40 days
- GMP You Need on Your First Day in a Pharma Plant12-2343 daysGMP You Need on Your First Day in a Pharma Plant | 2026-12-23 | 43 days
- GMP × Project Management: Seeing GMP Through a Project Manager's Eyes (TBD)01-0152 daysGMP × Project Management: Seeing GMP Through a Project Manager's Eyes (TBD) | 2027-01-01 | 52 days
- Why Did One Acne Lotion Spark Four FDA Questions? | How a GMP Inspector Would Ask10-24PublishedWhy Did One Acne Lotion Spark Four FDA Questions? | How a GMP Inspector Would Ask | 2026-10-24 | Published
- A "Fully Sealed" Wall. So How Did the Drug Get Across?10-31PublishedA "Fully Sealed" Wall. So How Did the Drug Get Across? | 2026-10-31 | Published
- Unclaimed Raw Data Found in a Shred Bin | How a GMP Inspector Would Ask11-03PublishedUnclaimed Raw Data Found in a Shred Bin | How a GMP Inspector Would Ask | 2026-11-03 | Published
- Nearly Every Validation Cycle Grew Bacteria. Why Did It Still "Pass"? | How a GMP Inspector Would Ask11-06PublishedNearly Every Validation Cycle Grew Bacteria. Why Did It Still "Pass"? | How a GMP Inspector Would Ask | 2026-11-06 | Published
- Smoke Too Thin to See, Yet Airflow Rated "Excellent"? | How a GMP Inspector Would Ask11-09PublishingSmoke Too Thin to See, Yet Airflow Rated "Excellent"? | How a GMP Inspector Would Ask | 2026-11-09 | Publishing
- A Ceiling That Is Neither Waterproof Nor Cleanable, in an Aseptic Filling Room | How a GMP Inspector Would Ask11-122 daysA Ceiling That Is Neither Waterproof Nor Cleanable, in an Aseptic Filling Room | How a GMP Inspector Would Ask | 2026-11-12 | 2 days
- Batch Record Says 12 Interventions; Reality Was About 200 | How a GMP Inspector Would Ask11-155 daysBatch Record Says 12 Interventions; Reality Was About 200 | How a GMP Inspector Would Ask | 2026-11-15 | 5 days
- The Same Test Run 11 Times, None of It Recorded | How a GMP Inspector Would Ask11-188 daysThe Same Test Run 11 Times, None of It Recorded | How a GMP Inspector Would Ask | 2026-11-18 | 8 days
- An 18 mm Piece of Glass in a Vial | FDA 483 Case10-24PublishedAn 18 mm Piece of Glass in a Vial | FDA 483 Case | 2026-10-24 | Published
- Cleared to Ship Before the Tests Are Done | FDA 483 Case10-29PublishedCleared to Ship Before the Tests Are Done | FDA 483 Case | 2026-10-29 | Published
- Fill Volume Set by a Recipe That Was Never Validated | FDA 483 Case11-01PublishedFill Volume Set by a Recipe That Was Never Validated | FDA 483 Case | 2026-11-01 | Published
- Glass, Black Fibers and Hair Barely Detected, Yet the Total "Passes" | FDA 483 Case11-04PublishedGlass, Black Fibers and Hair Barely Detected, Yet the Total "Passes" | FDA 483 Case | 2026-11-04 | Published
- Three reports, but the plasmid lengths don't match | FDA 483 Case11-07PublishedThree reports, but the plasmid lengths don't match | FDA 483 Case | 2026-11-07 | Published
- Condensation Everywhere, So No One Could See a Leaking Bag | FDA 483 Case11-10PublishingCondensation Everywhere, So No One Could See a Leaking Bag | FDA 483 Case | 2026-11-10 | Publishing
- Rework on the Packaging Line, Without Quality Knowing | FDA 483 Case11-133 daysRework on the Packaging Line, Without Quality Knowing | FDA 483 Case | 2026-11-13 | 3 days
- 80 Bacterial Isolates, 8 Batches Rejected, Still "No Impact on Quality" | FDA 483 Case11-166 days80 Bacterial Isolates, 8 Batches Rejected, Still "No Impact on Quality" | FDA 483 Case | 2026-11-16 | 6 days
- Leadership · Mental Models
- Human 3.0 Explained: Dan Koe's Map for Mind, Body, Spirit & Vocation10-18PublishedHuman 3.0 Explained: Dan Koe's Map for Mind, Body, Spirit & Vocation | 2026-10-18 | Published
- We Always Have a New Self to Discover｜Dan Koe: Reset Your Life in a Day10-28PublishedWe Always Have a New Self to Discover｜Dan Koe: Reset Your Life in a Day | 2026-10-28 | Published
Latest videos
FDA 483 Case
Three reports conflict; the third gives only a lower bound on plasmid length.
How a GMP Inspector Would Ask
Positive biological indicators in almost every decontamination validation cycle.
Series
GMP Concepts
GMP Concepts takes one topic per episode, from the quality system, documentation and validation to sterile products and batch release: 22 episodes in course order, including the early-release Computerized Systems episode. A new one comes out about every three days, in English and Chinese on the same day.
22 episodes · 6 publishedAll →
Frameworks Decoded
An animated walk through Dan Koe's Human 3.0 framework: one growth map for mind, body, spirit and vocation.
2 episodes · 2 publishedAll →
How a GMP Inspector Would Ask
Two-to-three-minute vertical shorts that start from a real FDA warning letter and follow the questions an inspector would ask. Each one shares its topic with the GMP Concepts episode from the day before; a new one every three days.
23 episodes · 4 publishedAll →
FDA 483 Case
Each episode unpacks one real FDA Form 483 observation: what went wrong and why it ended up in the report. Vertical shorts, a new one every three days.
23 episodes · 5 publishedAll →
