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)... ... October 12, 2017 , ... ... the three Winners and six Finalists of the 2017 Blavatnik Regional Awards for ... Blavatnik Family Foundation and administered by the New York Academy of Sciences to ...
(Date:10/12/2017)... ... October 12, 2017 , ... BioMedGPS announces expanded ... of its newest module, US Hemostats & Sealants. , SmartTRAK’s US Market for ... fibrin sealants, synthetic sealants and biologic sealants used in surgical applications. BioMedGPS estimates ...
(Date:10/11/2017)... ... 2017 , ... At its national board meeting in North ... the co-founder, CEO and chief research scientist of Minnesota-based Advanced Space Technology and ... ARCS Alumni Hall of Fame . ASTER Labs is a technology development ...
(Date:10/11/2017)... ... October 11, 2017 , ... ComplianceOnline’s Medical Device Summit is back ... 8th June 2018 in San Francisco, CA. The Summit brings together current and former ... CEOs, board directors and government officials from around the world to address key issues ...
Breaking Biology Technology:
(Date:4/6/2017)... Forecasts by Product Type (EAC), ... End-Use (Transportation & Logistics, Government & Public Sector, Utilities ... Generation Facility, Nuclear Power), Industrial, Retail, Business Organisation (BFSI), ... you looking for a definitive report on the $27.9bn ... ...
(Date:4/5/2017)... Today HYPR Corp. , leading innovator ... of the HYPR platform is officially FIDO® Certified ... architecture that empowers biometric authentication across Fortune 500 enterprises ... over 15 million users across the financial services industry, ... product suites and physical access represent a growing portion ...
(Date:4/4/2017)...   EyeLock LLC , a leader of iris-based ... Patent and Trademark Office (USPTO) has issued U.S. Patent ... an iris image with a face image acquired in ... 45 th issued patent. "The ... the multi-modal biometric capabilities that have recently come to ...
Breaking Biology News(10 mins):