Contents Chapter 1 The Journey begins Chapter 2 Food work Chapter 3 BIMO Training Chapter 4 BIMO Inspections Chapter 5 International BIMO Inspections Chapter 6 Official-Action-Indicated (OAI) Work Chapter 7 Electronic-Records Review Chapter 8 Regional/District Management Issues Preface A few years ago, I put together a collection of my thoughts regarding the US FDA and my personal experiences over 13 years as a field investigator in Texas. Since then I have had the opportunity to experience a world of new opportunities as a consultant, so I thought it was time to revisit the Bubblegum Badge world. Along with a few colleagues, I have added several new sections and have tightened up some of the language and phrasing. It is, as with everything in life, still a work in progress.... As I said in the first edition of this book, I donat intend this book to be either a roasting or a toasting. I hope what it will do is provide a glimpse of what the FDA does well, and what it needs to improve on (as evidenced by audit reports from the Health and Human Services [HHS] Office of Inspector General [OIG]). The name aBubble Gum Badge, a by no means suggests a weak or ineffective organization, rather, it is something my friend from the Imports Division stated during a happy hour we were at in 1999. He put it this way: aIf you think that gold FDA badge is going to get you out of trouble, son, you are wrong! Itas a Bubble Gum Badge and is more trouble than you have ever known.a Thankfully, I did not get into any real trouble as a young man with a great responsibility to protect and serve. There are many ways to keep harmful products from the US market, and some of which take longer than the proverbial slow boat to China. I was a frontline grunt out in the field, conducting the FDA business of the day. Those twelve years and eight months were some of the most challenging and rewarding moments any one person could ask for. When you sit down to eat today or see your family member take their medications or go into surgery, you can rest assured that at least one of the FDAas finest had at some point in the productas life cycle taken a look to see if it passed inspection. FDA does the work that is most taken for granted and expected as a given by the US public. Your tax dollars were always hard at work when I was on the job, even though it may not have always appeared that way. I would like to thank the FDA for taking me around the world and giving me the best training anyone can ask for in this quality assurance (QA) business (on-the-job training). FDA needs your help and more regulatory authority for biologics, drugs, and devices. Only Congress can grant more FDA authority, and budget battles seem to be the mainstay. Most of the information I reference comes from the public domain site www.fda.gov. The FDAas mission is too important not to be modernized, supported, and innovated. FDA falling behind in modernization would mean lives at risk globally. The oversight of our global health market is waiting. If you want it and qualify, your official gold FDA badge is waiting for you. FDA has mine in a vault next to my government international passport (I have my old decommissioned one). Anyone reading this book can be an FDA Consumer-safety officer (CSO)/investigator. Trust me when I say sixty semester hours of accredited college science and some luck on the computer lottery (usaJobs.opm.gov) and youare in. I would suggest higher than a Bachelor of Science education for entry into bioresearch monitoring. As an ex-FDA recruiter and mentor to many new hire FDA field investigators, I would say a graduate degree or higher also assures your entry to drug and device program field work. So, take a look behind the kitchen, Pharmacy, and hospital operation-room doors with me. Thank you, global health providers and professionals (all of you)! Thank you, health-care receivers, all of you; without you, there would be no need for health-care products. I think that includes everyone in the world! Thank you for your time and for coming along to take a microscopic view into one of the most unsung agencies. FDA has very little glitz or glamour and I hope you find something you find interesting in this book.FDA does not require IRBs to have ethicists on staff, but do not be surprised when it is required guidance in the 21 CFR. Many changes ... Most IRBs have a department or team looking at the informed-consent form (ICF) elements. I would hopeanbsp;...
|Title||:||Bubble Gum Badge|
|Publisher||:||Xlibris Corporation - 2011-07-22|