Monday, April 25, 2011

FDA Priorities For 2011-2015

The U.S. Food and Drug Administration (FDA) today released the final version of a strategic priorities document outlining the goals that will guide the agency and its 12,000 employees through 2015, FDA’s “Strategic Priorities 2011 – 2015: Responding to the Public Health Challenges of the 21st Century” (PDF).

It conveys the FDA's vision for the future, by mentioning:
  • a modernized field of regulatory science that draws on innovations in science and technology to help ensure the safety and effectiveness of medical products throughout their life cycles
  • an integrated global food safety system focused on prevention and improved nutrition
  • expanded efforts to meet the needs of special populations.
The document is organized into four major sections:
1.0 Introduction 
2.0 Cross-Cutting Strategic Priorities
3.0 Strategic Goals and Long-Term Objectives
4.0 Implementation


You might also be interested in:
Strategic Priorities Blog posting by FDA Commissioner Margaret A. Hamburg


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Friday, April 22, 2011

Easter Egg Food Safety

Easter 2010Image via Wikipedia
Easter is here, and you need to pay attention to the food safety and handling of foods containing eggs, especially your Easter eggs.

Checkout this website:  Kraft Foods - Easter Egg Safety

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Wednesday, April 13, 2011

GMP Training Tool - Meeting Timer

Lux Products' Minute Minder timer.Image via Wikipedia
I needed a little timer app and found this online for free:
Meeting Timer (free)

GMP trainers, facilitators, and others should find this a useful application.

Here's what I like about it, it's
  • free
  • easily installed
  • resizable
  • very intuitive
  • compatible with how we use Powerpoint
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FDA - 21 CFR 820 - Formatted for Mobile
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Monday, April 11, 2011

Big Pharma Drug Theft Problem

An illustration of a company's supply chainImage via Wikipedia
Uh-oh.

Katherine Eban reports in Fortune Magazine, Drug theft goes big - Organized gangs are stealing prescription medicine in increasingly audacious heists - That's a problem for Big Pharma and for patients, who can unknowingly buy stolen -- and sometimes dangerous -- medications.

In a nutshell, drug warehouses and supply chains appear to be vulnerable. In some cases, the vulnerabilities allow for stolen, unapproved, illegally imported, expired, and counterfeit drugs to get into the marketplace.

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FDA - 21 CFR 820 - Formatted for Mobile
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Monday, April 4, 2011

FDA and EPA Nuclear Radiation Monitoring

Internationally recognized symbol.Image via Wikipedia
Here's a better set of webpages that offer information about possible nuclear radiation reaching the United States.

Joint EPA/FDA Statement: Update on Ongoing Monitoring - on steps taken to increase the level of nationwide monitoring of milk, precipitation, drinking water, and other potential exposure routes.


EPA's RadNet Monitoring Data - a map of radiation monitoring stations

EPA - Daily Data Summary - from the EPA's RadNet Monitoring Data

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GMP Posters
The Health, Drug, Prescription, and GMP Supersite Gift Store
FDA - 21 CFR 820 - Formatted for Mobile
Return to Mobile Home: http://drughealth.prohost.mobi

iOSAT Potassium Iodide Tablets, 130 mg (14 Tablets)

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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