Monday, March 14, 2011

Failed FDA Inspections - 483s - Failure or Out Of Compliance!?

The stats are pretty shocking! But what does it really mean? ... Which Drugmaker Fails Most FDA Inspections? 

Ed Silverman and commenters are having a lively conversation on the topic.

You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.
This class prepares plant personnel to participate in an FDA Inspection.
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Posted by Austin Lee at 8:30 AM
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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
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