Norm Howe's blog

Border Wars: What Are the Boundaries between FDA and USDA?

The responsibilities of the Food and Drug Administration and the US Department of Agriculture would seem to be clear cut.  FDA is responsible for Food, Drugs, and Cosmetics while USDA is responsible for agricultural products, right?  But an agricultural product can become a food, drug, or cosmetic.  Where in the supply chain does a product make the transition from one jurisdiction to the other?  Well, it turns out to be right in the middle of your sandwich.  If it's an open-face sandwich, it's regulated by USDA.  If it's closed-face, it's FDA.

A Lesson in Leadership from Muhammad Ali

Before his fight with Henry Cooper Muhammad Ali trash talked, 'This is no jive, Cooper shall go in five.'  Everyone assumed that he was simply trying to unnerve his opponent.  That’s true, but he had a more important goal as well.  And he was far from the first person in history to set it.

Your Project is You

body outlineThe body lies unrecognized in the hallway.  People hurry past on their way to somewhere, holding their breath until they get upwind.  Some step gingerly over it.  Some tiptoe around it.  One or two glance at you, hesitate, then think better of it.

Soon, the whitecoats will scrape the body from the floor and conduct a speedy autopsy.  The cause of death will be assigned.  The perpetrator is predetermined.  You already know who it is.

The Quality Inspector and the Lizard

Monitor LizardMy business partner, Nicole, has one of the quickest minds in our business, quality consulting for drugs and medical devices.  But I’m blown away at her response to the revelation that confronted her during a recent audit. 

WHAT MAKES A GREAT TRAINING PRESENTATION?

shockedHas someone asked you to train a group of people?  Maybe you’re the expert on a subject that no-one else in the organization knows how to do. 

Do you feel flattered that you’ve been asked to help others learn this important skill?  Yet, you’re getting sick at your stomach because you have no clue how to create training for a team of adults?

THINKING OUT OF THE BARREL

RaccoonDo you ever find yourself facing an impossible task?   In our consulting work we frequently have to tell our clients that they need to achieve seemingly unattainable quality goals, while at the same time the market is forcing costs to be cut. 

When we tell those customers that we have seen many instances like the situations they are finding themselves in; and we further tell them that we have helped our clients to resolve both objectives, we are met with understandable skepticism

Why Not Totally Awesome Manufacturing Practices?

belt and suspendersWhy do we say GOOD Manufacturing Practices?  Why not Perfect Manufacturing Practices?  Do we want our drugs and medical devices to be anything less than perfect?  Why not at least Great Manufacturing Practices?  How about this?  Why not Totally Awesome Manufacturing Practices. 

Make Regulatory Compliance Easy by Not Thinking about It

Companies go through two stages when they try to become compliant with FDA regulations.  Stage one is to write all the procedures that translate the regulations into specific actions for the employees.  That’s hard enough.  In stage two the company has to get all its employees to follow those procedures. 

This is the stage where so many companies get lost in the weeds.  Most companies spend much more effort on stage two than stage one.

Napoleon’s Secret Weapon

Napoleon…now you can learn it; better yet, it’s free.

Napoleon knew how to inspire great achievements in others.  Why everyone doesn’t make use of Napoleon’s knowledge, I don’t know.  They could dramatically improve performance, if they did.  Before I tell you Napoleon’s secret, you should understand why you probably don’t already know it. 

Why Does FDA Hamstring Dietary Supplement Manufacturers?

Why?FDA gives greater flexibility to drug makers than to Dietary Supplement manufacturers.  Why?  Moreover, the flexibility that FDA accords drug makers actually allows them to build better quality into their products than dietary supplement manufacturers.

Pages