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Tuesday, November 30, 2010
FDA Home Use Device Initiative
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Tuesday, November 23, 2010
Turkey Talk - Avoid Getting Sick
Thanksgiving is here. I'm reprising one of my oldie but goodie posts, Time To Talk About Turkey Cooking and Food Safety. Follow the link to a well written set of do's and don'ts. As a bonus there are additional links that might pique your interest.
For fewer clicks, here's the real 'meat' of the matter:
Let's Talk Turkey—A Consumer Guide to Safely Roasting a Turkey
Enjoy your safe, and well-prepared Turkey dinner!
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Monday, November 22, 2010
10 Golden Rules of GMP - Free Tips
This free GMP white paper from PharmOut is a great read, White Paper - The 10 Golden Rules of GMP (pdf).
You get a quick list of the 10 golden rules, an excellent explanation of each rule, and finally a self-audit checklist.
Enjoy!
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Thursday, November 18, 2010
FDA Quit Smoking Resources and the Great American Smokeout
More Stuff:
The Easy Way to Stop Smoking: Join the Millions Who Have Become Non-smokers Using Allen Carr's Easy Way Method
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Monday, November 15, 2010
Drugs and Supplements From China Still Largely Unregulated
Probably not surprising, and certainly disappointing, as reported by this KansasCity.com news article, Drugs, supplements come to U.S. from China largely unregulated.
I'm most concerned about, "One consequence of the lack of regulation has been a rising number of counterfeit drugs."
Related links:
GAO Report Blasts FDA for Failure to Implement 2008 Recommendations
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Wednesday, November 10, 2010
Shocking FDA Images For Cigarette Packages
More Information:
FDA Proposed Cigarette Product Warning Labels
Stop Smoking:
Quit Smoking Today (http://www.smokefree.gov/)
Nicoderm CQ Step 1 Clear Patch 14-pk.
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Monday, November 8, 2010
FDA GMP Books - Limited Previews
Image via WikipediaI'm a big fan and user of many of Google's offerings. While wandering through Google Books, I ran across these limited previews of these three FDA GMP-related books. I thought you might be interested. Although the previews are limited, there's certainly enough content that can be read for learning, and plenty to review if you're considering buying the book.
Interpretation of FDA's Quality System Regulations (QSR) With QSIT references By Medical Device School (Google books preview)
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices (Google books preview)
Buy the book: The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition
Buy the book: Good Manufacturing Practices for Pharmaceuticals, Sixth Edition
(Kindle Edition)
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Monday, November 1, 2010
Staying Alive - New AHA 2010 CPR Technique (video)
This is a major change. Watch this video to learn about the American Heart Association (AHA) 2010 Guidelines for CPR. The guidelines mention the song Stayin' Alive for the compression rate of 100 beats per minute.
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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
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
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