Predict Or Avoid Having Your Medical Manufacturing Facility Inspected By The FDA, With The New 1999 QSR Manual

Quality Systems Regulation (QSR) 1999 reveals all-new advice/analysis on how to predict or even avoid having your medical manufacturing facility inspected by the FDA. The cornerstone FDA regulatory guidance manual was updated and published several days ago exclusively by Biomedical Market Newsletter.

It applies to manufacturers/distributors of any medical device, instrument, equipment, test, biological, supply or drug reviewed by FDA. This 1999 edition includes eight new previously unpublished documents. These help predict when companies can implement changes in manufacturing facilities, manufacturing methods or procedures, labeling, design or performance.

This incredibly valuable information details what circumstances require submission of a supplemental FDA application, when to expect FDA inspections of your manufacturing facility, and when documenting the change in the company's FDA files may be adequate.

The 1999 QSR Special Update (175 pages) -- available as a bound volume only from BMN -- can either be purchased separately or together with the original first edition (published January 1997). The original 500-page QSR has 155 pages of charts/sample forms.

BMN's Internet Web site shows the QSR, Table of Contents and sample page. It can be accessed at: http://www.biomedical-market-news.com/qsregman.html.