Monday, December 26, 2011

FDA ramps up role as safety sheriff

FDA ramps up role as safety sheriff - Omaha.com:

"The federal Food Safety Modernization Act will result in numerous changes — some large, some small — for food manufacturers and farmers in 2012 and beyond as the Food and Drug Administration continues its slow, steady rollout of new regulations. During the new law's first year, little has changed other than sweeping educational efforts to prepare farmers and food manufacturers for ramped-up federal inspection efforts. The inspections will include more, and increasingly intense, reviews of food safety and health protocols. But for 2012 and beyond, companies are preparing for financial effects. Over the next five years, the FDA is planning to issue more than 50 new rules, add inspectors and ramp up oversight efforts to the tune of $1.4 billion."
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Saturday, December 24, 2011

Happy Holidays!

Wishing all of you a safe and heartfelt holiday!

 

Tuesday, December 20, 2011

2012 Predictions for Global Supply Chains

Supply Chain Matters Blog 2012 Predictions for Global Supply Chains- Part One | Supply Chain Matters:

"We will kick-off this series with the full listing of our ten predictions for the upcoming year.  In upcoming postings, we will provide the detailed thoughts supporting each prediction."
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You might also be interested in:
Auditing: Internal and External Customers and Suppliers - training by SkillsPlus International Inc.

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Monday, December 19, 2011

2012 Crystal Ball Predicts a More Aggressive FDA

2012 Crystal Ball Predicts a More Aggressive FDA:

"According to the FDA website, 2012 will be a year of global regulatory operation and enforcement with emphasis on medical devices, drugs, and food products. "
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The article references:
The FDA Pathway to Global Product Safety and Quality

It's hard to believe 2011 is nearly over, and 2012 is around the corner.  Here's to future trends!

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Thursday, December 15, 2011

FDA Crackdown on Viagra-Like Supplements

FDA Crackdown on Viagra-Like Supplements - Video - Bloomberg:

"The discovery came during a Food and Drug Administration inspection that’s part of an expanding crackdown by the agency on the $28 billion supplement industry."
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My gut sense tells me that this is just the tip of the iceberg, a problem of enforcement that the FDA will be hard pressed to wrap their arms around.
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Tuesday, December 13, 2011

FDA Update - HCG Diet Products Are Illegal

Consumer Updates; HCG Diet Products Are Illegal:

"The Food and Drug Administration (FDA) is advising consumers to steer clear of these "homeopathic" human chorionic gonadotropin (HCG) weight-loss products. They are sold in the form of oral drops, pellets and sprays and can be found online and in some retail stores. "
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You might be interested in these items:
Tiger Woods TW Cap BLACK Size M/L
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Visit Our Baking Store for Holiday Cooking Products
Wine Lovers Dishwasher Magnet
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Monday, December 5, 2011

FDA-approved hangover pill

Cheers! FDA-approved hangover pill promises to take edge off holiday partying - NY Daily News:

"A new FDA-approved hangover cure has hit the market just in time for holiday party season."
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This new product is called Blowfish:



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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     Oriental Trading Co - Training toys and supplies     GMP Training Gifts & Giveaways     GMP Training & Quality Posters