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"Significant" procedural lapses earn IRB a write-up.(Texas Applied Biotechnology Services Research Review Committee Institutional Review Board)(Brief ... An article from: Bioresearch Monitoring Alert
🇺🇸 United States
"Significant" procedural lapses earn IRB a write-…
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QS deficiencies, use of cat for rodent control lands IVD exporter 483, warning.(Medical Devices): An article from: Inspection Monitor
🇺🇸 United States
QS deficiencies, use of cat for rodent control lands IVD ex…
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Accreditation of organizations and researchers, plus data-mining seen as future of clinical research.(Accreditation): An article from: Bioresearch Monitoring Alert
🇺🇸 United States
Accreditation of organizations and researchers, plus data-m…
By: Elisa Ludwig
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While excipients stay low-risk, FDA inspection policy will stay business as usual. (Excipients).: An article from: Validation Times
🇺🇸 United States
While excipients stay low-risk, FDA inspection policy will …
By: Kelly Huegel
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AAI escapes 483 despite lack of validation data, testing deficiencies.(Human Drugs): An article from: Inspection Monitor
🇺🇸 United States
AAI escapes 483 despite lack of validation data, testing de…
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AAI lacked validation data, evades 483.(Human drugs): An article from: Validation Times
🇺🇸 United States
AAI lacked validation data, evades 483.(Human drugs): An ar…
By: Tamra Sami
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OOS procedures should be part of development phase.(out of specifications)(Brief Article): An article from: Validation Times
🇺🇸 United States
OOS procedures should be part of development phase.(out of …
By: Peter Dechnik
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Batelle receives 483 for inadequate maintenance of facility, procedural issues in GLP inspection. (Sponsor-monitors/GLP).(Batelle Memorial Institute, ... An article from: Bioresearch Monitoring Alert
🇺🇸 United States
Batelle receives 483 for inadequate maintenance of facility…
By: Tamra Sami
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Documentation issues follow Florida investigator from NIH. (Sponsor-monitors/GLP).(National Institutes of Health, University of Florida; assays for drug): An article from: Bioresearch Monitoring Alert
🇺🇸 United States
Documentation issues follow Florida investigator from NIH. …
By: Tamra Sami
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Most revisions in manufacturing, specifications seen as 'major' in guide.(FDA Modernization Act of 1997 )(Brief Article): An article from: Validation Times
🇺🇸 United States
Most revisions in manufacturing, specifications seen as �…
By: Ken Reid
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Retrospective validation helps Nova clear hurdles.: An article from: Inspection Monitor
🇺🇸 United States
Retrospective validation helps Nova clear hurdles.: An arti…
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INSPECTION LOG.(Food and Drug Administration)(documents available under)(Freedom of Information Act)(Brief Article): An article from: Inspection Monitor
🇺🇸 United States
INSPECTION LOG.(Food and Drug Administration)(documents ava…
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New testing facility guide replaces inspection checklist.(Food and Drug Administration inspection guidelines)(Brief Article): An article from: Inspection Monitor
🇺🇸 United States
New testing facility guide replaces inspection checklist.(F…
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8-step approach suggested for sponsors to audit CROs. (CROs).(contract research organization): An article from: Bioresearch Monitoring Alert
🇺🇸 United States
8-step approach suggested for sponsors to audit CROs. (CROs…
By: A.E. Sadler
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X-ray maker cited for design controls, environmental issues, calibration.(Brief Article): An article from: Validation Times
🇺🇸 United States
X-ray maker cited for design controls, environmental issues…
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Preventive maintenance key to avoiding HVAC-themed 483s. (Utilities).: An article from: Validation Times
🇺🇸 United States
Preventive maintenance key to avoiding HVAC-themed 483s. (U…
By: Elisa Ludwig
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Aventis audit triggered by complaints of false lab data.: An article from: Validation Times
🇺🇸 United States
Aventis audit triggered by complaints of false lab data.: A…
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Audits give mixed reviews to new software at ARC.(American Red Cross)(Brief Article): An article from: Inspection Monitor
🇺🇸 United States
Audits give mixed reviews to new software at ARC.(American …
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Butyl acetate use vs. water gives Chemcentral a 483.(Brief Article): An article from: Inspection Monitor
🇺🇸 United States
Butyl acetate use vs. water gives Chemcentral a 483.(Brief …
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Checklists, code prompt FDA to dig deeper: consultant.(Food and Drug Administration, inspection of pharmaceutical industry computer systems)(Brief Article): An article from: Validation Times
🇺🇸 United States
Checklists, code prompt FDA to dig deeper: consultant.(Food…
By: Peter Dechnik
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Study coordinator complaint triggers four-month audit, resulting in 12-page 483. (Clinical investigators).: An article from: Bioresearch Monitoring Alert
🇺🇸 United States
Study coordinator complaint triggers four-month audit, resu…
By: Tamra Sami
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FDAer urges sponsors to cultivate whistle blowers, not fear reporting to FDA. (Sponsor/monitors).: An article from: Bioresearch Monitoring Alert
🇺🇸 United States
FDAer urges sponsors to cultivate whistle blowers, not fear…
By: Elisa Ludwig
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Commissioning HVAC systems best done with team, including validation personnel. (Commissioning).: An article from: Validation Times
🇺🇸 United States
Commissioning HVAC systems best done with team, including v…
By: Elisa Ludwig
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Drug firms wasting energy on HVAC due to outdated standards recognized by FDA. (Cleanrooms).: An article from: Validation Times
🇺🇸 United States
Drug firms wasting energy on HVAC due to outdated standards…
By: Elisa Ludwig
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Zenith's P.R. facility cited for production, quality system issues.(Human Drugs): An article from: Inspection Monitor
🇺🇸 United States
Zenith's P.R. facility cited for production, quality s…
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FDAer says firms should go beyond 'functional testing'.(Food and Drug Administration's James McCormack discusses software validation)(Brief Article): An article from: Validation Times
🇺🇸 United States
FDAer says firms should go beyond 'functional testing&…
By: Dan Whipple
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OHRP reviews 100 cases a year, but fewer than eight go anywhere. (IRBs).: An article from: Bioresearch Monitoring Alert
🇺🇸 United States
OHRP reviews 100 cases a year, but fewer than eight go anyw…
By: Tamra Sami
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IRISH EYES UNHAPPY OVER WARNING LETTER.(Vitalograph inspection finds process control problems): An article from: Inspection Monitor
🇺🇸 United States
IRISH EYES UNHAPPY OVER WARNING LETTER.(Vitalograph inspect…
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IVD maker's sterilization, internal audits draw fire. (in-vitro fertilization equipment, Mid-Atlantic Diagnostics).(Brief Article): An article from: Validation Times
🇺🇸 United States
IVD maker's sterilization, internal audits draw fire. …
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Tyco told to reign in questionable sterility validation at Radionics.(Brief Article): An article from: Validation Times
🇺🇸 United States
Tyco told to reign in questionable sterility validation at …
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IRB kept sloppy records, failed to review critical information.(IRBs)(Huntsville Hospital)(Institutional Review Board ): An article from: Bioresearch Monitoring Alert
🇺🇸 United States
IRB kept sloppy records, failed to review critical informat…
By: Tamra Sami
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Companies go beyond quality systems to quality culture.(Quality systems): An article from: Validation Times
🇺🇸 United States
Companies go beyond quality systems to quality culture.(Qua…
By: Elisa Ludwig
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