483s/EIRs on DVD brings you all the critical inspection records you need … in one handy source. After collecting thousands of 483s and EIRs through the years, our RECORD-RETRIEVE Service, the industry’s leading source of FDA documents, now offers these records to you in a convenient electronic format. With 483s/EIRs on DVD, you can access and read hundreds of 483s and EIRs going back as far as 1991 — providing you with more than 15 years of FDA inspection history. What’s more, our convenient index allows you to locate 483s and EIRs by manufacturer name AND inspection date! Read 483s for drugs, devices, biologics and GCP/GLP (BiMo) inspections. It will save you hours on research.
See if a clinical investigator, CRO or IRB had trouble with FDA before you work with them on a human study. This CD contains valuable, hard-to-retrieve details of FDA BiMo inspections.
Find out which of your competitors were inspected and get the details of their 483s and EIRs. Examine how specific FDA inspectors audited drug manufacturing facilities -- both in the U.S. and overseas. Disk contains all types of human/animal drug manufacturer inspections -- pre-approval, API, for cause, etc.
Learn the ins and outs of Quality Systems audits and design controls by examining these medical device 483s and EIRs. PDFs also note how specific inspectors handled audits. CD is chock full of details to help you avoid a 483, warning letter or adverse action by FDA.
Get 10 years of FDA warning and untitled letters on DVD for just $995 . The entire collection of Warning Letter Bulletin summaries are available on DVD* – more than 10 years of FDA WARNING AND UNTITLED LETTER SUMMARIES for drugs, devices and biologics – all in one handy resource! Now you can search by product name, company, type of infraction, FDA inspection district, etc. Just open the various files and use your search command in Word or Adobe PDF. It's that simple! Not only will you be able to RESEARCH YOUR COMPETITION more easily with this valuable information, you can gain confidence in your decisions, get a reality check on whether you are in compliance and avoid getting blind-sided by an inspection! Whether you're in pharmaceuticals, devices, blood banks or any other industry FDA regulates, you'll value the insider knowledge, the quick read and easy index. The regular rate of the entire collection is $2995 – However, you can order this valuable DVD now for ONLY $995!
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