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Saturday, March 13, 2010
Dietary Supplements - Tips for FDA Inspection
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Top Content And Other Useful Links
- GMP Posters - for Training & Quality
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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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1 comments:
We live in a very unique time in history. People today have access to more information than any other generation before us. As a result, we must be aware of what is good and what is bad data – what to let in as valid information and what to net out. Hard to do when we are inundated with tempting phrases like, “No dieting! Just take one Hoopdedoo pill a day and be twenty pounds thinner in just one week!” Our brain tells us that’s just nonsense, but then a little voice goes off and says “Hmm…I wonder if its true…” Some unscrupulous manufacturers count on that little voice. These manufacturers are allowed to advertise with little constraint due to U.S. marketing laws regarding anything under the banner of “health supplements”. The Food and Drug Administration (FDA) is engaged in an ongoing crusade to regulate some health supplements that could cause severe potential health risks and even death, however, Congress isn’t making the struggle any easier. “In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which effectively allowed manufacturers of everything from weight loss pills to cholesterol-lowering supplements to put their products in front of consumers without regulatory oversight.” (Dangerous Supplements Pose Challenges to FDA - article on www.HG.org. Sept. 29, 2009 provided by the Law Offices of Tyler & Perry).
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