Image via WikipediaHere's a short and sweet digestible tip sheet, from Chromadex, on how to successfully tackle the FDA GMPs for Dietary Supplements, Dietary Supplement cGMP Highlights and Tips for Success - Tech Tip 0014 (PDF)
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The ADA Guide to Herbs and Nutritional Supplements
Monday, August 30, 2010
GMP Success Tips For Dietary Supplements
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Wednesday, August 25, 2010
10 Bad Things That Can Be Good For Your Health
I love this article I read on CNN.com, America's healthiest pleasures: 10 'vices' that are good for you. This means I get to do a bunch of things without feeling guilty, and get a health benefit too!
I especially like indulging in coffee, chocolate, wine, sleep.... hmm, I think I like almost all ten!
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Wine Lovers Dishwasher Magnet
I especially like indulging in coffee, chocolate, wine, sleep.... hmm, I think I like almost all ten!
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Wine Lovers Dishwasher Magnet
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Tuesday, August 24, 2010
Pine Nuts Can Ruin Your Taste Buds
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Raw Pine Nuts (1 Pound Bag)
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Monday, August 23, 2010
Drug Safety and Accountability Act of 2010
Image via WikipediaBennet's press release, Senate Introduces New Bill on Drug-Manufacturing Quality Standards, says:
The bill would strengthen manufacturer quality standards, enhance the FDA’s ability to protect Americans through improved tracking of foreign manufacturing sites, and give the FDA much-needed authority to recall potentially dangerous drugs.Return Home: http://drughealth.blogspot.com/
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Thursday, August 19, 2010
FDA Urgent Egg Recall Due To Salmonella
Wow! These eggs are everywhere.
Be warned that these potentially contaminated eggs have traveled all over the country, reports this FDA news release, URGENT Nationwide Egg Recall - Eggs in Their Shells May Put Consumers at Risk for Salmonella.
If you've got eggs in the fridge, you probably want to read this urgent FDA update.
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Fundamental Food Microbiology, Fourth Edition
Be warned that these potentially contaminated eggs have traveled all over the country, reports this FDA news release, URGENT Nationwide Egg Recall - Eggs in Their Shells May Put Consumers at Risk for Salmonella.
If you've got eggs in the fridge, you probably want to read this urgent FDA update.
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Fundamental Food Microbiology, Fourth Edition
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Wednesday, August 18, 2010
FDA Says Giving Bones To Dogs Is Unsafe
The FDA says don't give your dog a bone. Here are 10 reasons why it’s a bad idea to give your dog a bone:
1. Broken teeth.
2. Mouth or tongue injuries.
3. Bone gets looped around your dog’s lower jaw.
4. Bone gets stuck in esophagus, the tube that food travels through to reach the stomach.
5. Bone gets stuck in windpipe.
6. Bone gets stuck in stomach.
7. Bone gets stuck in intestines and causes a blockage.
8. Constipation due to bone fragments.
9. Severe bleeding from the rectum.
10. Peritonitis.
Basically, all of these end up with a visit to a vet due to serious injury or death. For more details and explanations, read on:
FDA - No Bones About It: Bones are Unsafe for Your Dog
FDA - No Bones About It: Bones are Unsafe for Your Dog (PDF)
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1. Broken teeth.
2. Mouth or tongue injuries.
3. Bone gets looped around your dog’s lower jaw.
4. Bone gets stuck in esophagus, the tube that food travels through to reach the stomach.
5. Bone gets stuck in windpipe.
6. Bone gets stuck in stomach.
7. Bone gets stuck in intestines and causes a blockage.
8. Constipation due to bone fragments.
9. Severe bleeding from the rectum.
10. Peritonitis.
Basically, all of these end up with a visit to a vet due to serious injury or death. For more details and explanations, read on:
FDA - No Bones About It: Bones are Unsafe for Your Dog
FDA - No Bones About It: Bones are Unsafe for Your Dog (PDF)
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Monday, August 16, 2010
FDA Drug Identification Service
I was surprised to discover this service. According to the FDA Drug Identification webpage:
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"Division staff can identify drugs for you based on physical appearance (color, shape, size, etc.) and markings. Email DDI your drug description at druginfo@cder.fda.govReturn Home: http://drughealth.blogspot.com/
We will identify drugs for you as soon as possible. However, please note that this is not an emergency service. In the case of an emergency, please contact the Poison Control Center 1-800-222-1222."
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Tuesday, August 10, 2010
Be Vigilant - Drowning Is Silent
I was surprised to learn that people who are drowning are actually very quiet, and don't wave their arms above water, according to this Medical News Today article, Do You Know What Drowning Looks Like?
Bottomline, when things get very quiet, you must be vigilant. People drowning aren't likely to be able to shout or wave for help.
Have fun this Summer, be safe, and be vigilant.
More information:
CDC - Unintentional Drowning - Fact Sheet
Handbook on Drowning: Prevention, Rescue, Treatment
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Monday, August 9, 2010
FDA Orange Book - Most Current Versions
The FDA ensures that the Orange Book data files are kept current. Every effort has been made to prevent errors and discrepancies in the Approved Drug Products data files.
You can go to this FDA page to find the latest versions of the Orange Book, FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Included are the annual edition, supplements, and more, for this publication that identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act.
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Rachael Ray's Big Orange Book: Her Biggest Ever Collection of All-New 30-Minute Meals Plus Kosher Meals, Meals for One, Veggie Dinners, Holiday Favorites, and Much More!
You can go to this FDA page to find the latest versions of the Orange Book, FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Included are the annual edition, supplements, and more, for this publication that identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act.
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Rachael Ray's Big Orange Book: Her Biggest Ever Collection of All-New 30-Minute Meals Plus Kosher Meals, Meals for One, Veggie Dinners, Holiday Favorites, and Much More!
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Monday, August 2, 2010
FDA Advice On Medical Device and Hurricane Preparedness
Hurricane season is here.
Follow these tips and you should be well on your way to disaster preparedness, FDA Offers Tips about Medical Devices and Hurricane Disasters.
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Follow these tips and you should be well on your way to disaster preparedness, FDA Offers Tips about Medical Devices and Hurricane Disasters.
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Even More Resources, Books, & Things (many from Amazon.com)
FDA, GMPs, QSR, GCP, GLP, GXP:
21 CFR Parts 210 and 211: Drug Industry GMP's
Compact Regs Parts 807, 812, and 814: CFR 21 Parts 807, 812, and 814 Medical Device Approval (10 Pack)
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
Compact Regs Part 11: CFR 21 Part 11 Electronic Records; Electronic Signatures (10 Pack)
How to Fail an Fda Quality Audit: A Look at Some of the Causes of Failure to Comply With Fda Quality Regulations
Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance
How to Develop and Manage Qualification Protocols for FDA Compliance
Agent GXP FDA Part 11 Guidebook: The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, Food, ... Trials and GCP (Good Clinical Practices)
Development of Fda-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics
Design and Analysis of Clinical Trials: Concepts and Methodologies (Wiley Series in Probability and Statistics)
Clinical Studies Management: A Practical Guide to Success
Analytical Chemistry in a GMP Environment: A Practical Guide
Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies (Biotechnology and Bioprocessing Series)
Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook
Preclinical Drug Development (Drugs and the Pharmaceutical Sciences)
Group Sequential Methods: Applications to Clinical Trials (Chapman & Hall/Crc Interdisciplinary Statistics Series)
Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second Edition
Pharmaceutical Stress Testing: Predicting Drug Degradation (Drugs and the Pharmaceutical Sciences)
Cleaning Validation: A Practical Approach
Validated Cleaning Technologies for Pharmaceutical Manufacturing
Risk-Based Compliance Handbook
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume I (1)
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded (Volume 2)
Bioprocess Validation: The Present and Future
Laboratory Validation: A Practitioner's Guide
Quality Assurance Workbook for Pharmaceutical Manufacturers
Risk-based Software Validation: Ten Easy Steps
ISO 13485 and FDA QSR Internal Audit Checklist
ISO 13485:2003 & FDA QSR (21 CFR 820) Quality Manual, 34 Procedures and Forms
Training Resources:
1001 Ways to Reward Employees
Planning Programs for Adult Learners: A Practical Guide for Educators, Trainers, and Staff Developers, 2nd Edition
50 Creative Training Openers and Energizers
Personalized M&M Candies
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21 CFR Parts 210 and 211: Drug Industry GMP's
Training Resources:
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