Navigation Links
Who's that knocking at the door? Preparing for an FDA inspection

Businesses that manufacture FDA-regulated products are not the only ones that can be inspected by the U.S. Food & Drug Administration at any time. FDA also inspects clinical trial sites (studies in humans) and nonclinical laboratories that conduct animal, plant or microorganism studies used in FDA applications for drugs, biologics, or devices.

FDA enforces ......

Full article >>> examining equipment, reviewing documents, collecting product samples, and interviewing employees.

At the end of the inspection, if the investigator believes conditions deviate from FDA requirements or violative products exist, the investigator will issue a notice of inspectional observations (called a Form 483). The investigator will review the 483 and each observation with management-lev......

Full article >>> d follow-up and response procedures after the inspection ends.

Mock Inspections. Although a mock inspection cannot fully prepare one for the real thing, a simulated inspection helps identify possible weaknesses in the SOPs and provides personnel with a better appreciation of both the questions that they may be asked and the seriousness of the inspection process.

Regular re......

Full article >>> Business appears monthly on WTN.


......

Full article >>>
'"/>

Source:wistechnology.com By Patricia Kaeding 07/12/05


Related biology technology :

1. Whos right about Wisconsin - CDW or RedPrairie?
2. New Microarray Labeling Kit for Preparing cDNA Probes
3. Preparing for avian flu with information technology
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality ... Several trends in analytical testing are being attributed to new regulatory requirements for ...
(Date:10/11/2017)... Charlotte, N.C. (PRWEB) , ... October 11, 2017 ... ... ARCS® Foundation President Andi Purple announced Dr. Suneel I. Sheikh, the ... Laboratories ( ASTER Labs ), Inc. has been selected for membership in ...
(Date:10/11/2017)... ... , ... Personal eye wash is a basic first aid supply for any work environment, but ... do you rinse first if a dangerous substance enters both eyes? It’s one less decision, ... its unique dual eye piece. , “Whether its dirt and debris, or an acid or ...
(Date:10/11/2017)... ... 2017 , ... Proscia Inc ., a data solutions ... “Pathology is going digital. Is your lab ready?” with Dr. Nicolas Cacciabeve, Managing ... how Proscia improves lab economics and realizes an increase in diagnostic confidence.* ...
Breaking Biology Technology:
(Date:4/13/2017)... SANTA MONICA, Calif. , April 13, 2017 /PRNewswire/ ... New York will feature emerging and ... Innovation Summits. Both Innovation Summits will run alongside the ... variety of speaker sessions, panels and demonstrations focused on ... east coast,s largest advanced design and manufacturing event will ...
(Date:4/11/2017)... , April 11, 2017 No two ... researchers at the New York University Tandon School ... Engineering have found that partial similarities between prints ... used in mobile phones and other electronic devices ... The vulnerability lies in the fact that ...
(Date:4/5/2017)... 2017 Today HYPR Corp. , leading ... component of the HYPR platform is officially FIDO® ... security architecture that empowers biometric authentication across Fortune 500 ... secured over 15 million users across the financial services ... home product suites and physical access represent a growing ...
Breaking Biology News(10 mins):