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:2/24/2017)...  VWR Corporation (NASDAQ: VWR), the leading global independent provider ... today reported its financial results for the fourth quarter and ... 4Q16 record quarterly net sales of $1.13 ... basis. 4Q16 EMEA-APAC segment net ... the Americas net sales increased 2.5%, or down 0.9% on ...
(Date:2/23/2017)... The Fight Against Cancer Innovation Trust (FACIT) and the ... report that Fusion Pharmaceuticals Inc. (Fusion) has closed a ... – JJDC, Inc. (JJDC) as the lead investor. Additional, ... and Genesys Capital, as well as founding investor FACIT.  ... ...
(Date:2/23/2017)... ... February 23, 2017 , ... ... clearance to begin marketing the SPEAC® System, the Brain Sentinel® Seizure Monitoring and ... or in healthcare facilities during periods of rest. A lightweight, non-invasive monitor is ...
(Date:2/23/2017)... 2017  Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company ... announced that Linda Marbán, Ph.D, president and chief executive officer, ... Cowen and Company 37th Annual Health Care ... Boston, MA 29th Annual ... (12:00 pm ET) Dana Point, CA ...
Breaking Biology Technology:
(Date:2/1/2017)... IDTechEx Research, a leading provider of independent market research, business ... new report, Sensors for Robotics: Technologies, Markets and Forecasts 2017-2027 ... ... Revenues of ... for Robotics: Technologies, Markets and Forecasts 2017-2027: Machine vision, force sensing ...
(Date:1/26/2017)...  Acuity Market Intelligence today released the 2017 ...  Acuity characterizes 2017 as a "breakout" year for ... a new understanding of the potential benefits these ... identity are often perceived as threats to privacy ... of Acuity Market intelligence. "However, taken together these ...
(Date:1/23/2017)... latest mobile market research from Acuity Market Intelligence reveals ... average price of a biometric smartphone decreased from $849 ... are now 120 sub-$150 models on the market at ... a year ago at an average price of $127. ... Acuity Market Intelligence Principal, "Biometric Smartphones are a global ...
Breaking Biology News(10 mins):