Monday, March 23, 2009

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Wyeth receives 483 for validation, calibration deficiencies.(Human drugs): An article from: Validation TimesWyeth receives 483 for validation, calibration deficiencies.(Human drugs): An article from: Validation Times by Tamra Sami
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Guardian's computer, software and protocol validation draws warning letter.(Human drugs): An article from: Validation TimesGuardian's computer, software and protocol validation draws warning letter.(Human drugs): An article from: Validation Times
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Improper design and process validation nets 23-item 483 for Medsep.(Medical devices/biologics): An article from: Validation TimesImproper design and process validation nets 23-item 483 for Medsep.(Medical devices/biologics): An article from: Validation Times by Joseph Pickett
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Quality system, CAPA, MDR, and validation flaws land 19-item 483 for Wright Medical Technologies.: An article from: Validation TimesQuality system, CAPA, MDR, and validation flaws land 19-item 483 for Wright Medical Technologies.: An article from: Validation Times by Joseph Pickett
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'Intended use' is validation, FDA meeting told; better acceptance methods seen as key.(Acceptance criteria): An article from: Validation Times'Intended use' is validation, FDA meeting told; better acceptance methods seen as key.(Acceptance criteria): An article from: Validation Times by Tamra Sami
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Validation citations take firm out of pine oil market.(Ag-Mark, Pharma-Science Labs)(Brief Article): An article from: Validation TimesValidation citations take firm out of pine oil market.(Ag-Mark, Pharma-Science Labs)(Brief Article): An article from: Validation Times
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Clinical diagnostics hit for process validation. (Medical Devices).: An article from: Validation TimesClinical diagnostics hit for process validation. (Medical Devices).: An article from: Validation Times
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Life-Tech cited for sterilization validation, other GMP issues.(Medical Devices): An article from: Validation TimesLife-Tech cited for sterilization validation, other GMP issues.(Medical Devices): An article from: Validation Times
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Guidance/Regulation Tracker.: An article from: Validation TimesGuidance/Regulation Tracker.: An article from: Validation Times
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Catalytica 483 raises issue of enough validation staff. (Human Drugs).: An article from: Validation TimesCatalytica 483 raises issue of enough validation staff. (Human Drugs).: An article from: Validation Times
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Ciba Vision avoids 483 despite validation slips.(Brief Article): An article from: Inspection MonitorCiba Vision avoids 483 despite validation slips.(Brief Article): An article from: Inspection Monitor
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Shin Chang Medical lacks validation for sterilization, CAPA.(Medical devices): An article from: Validation TimesShin Chang Medical lacks validation for sterilization, CAPA.(Medical devices): An article from: Validation Times by Evelyn Heitman
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Ligand lacks refiltration, shipping validation.(Blood & Biologics): An article from: Validation TimesLigand lacks refiltration, shipping validation.(Blood & Biologics): An article from: Validation Times
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4 elements of successful validation procedures outlined.(Brief Article): An article from: Validation Times4 elements of successful validation procedures outlined.(Brief Article): An article from: Validation Times
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GMPs/Enforcement.: An article from: Validation TimesGMPs/Enforcement.: An article from: Validation Times
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Devices/Biologics.: An article from: Validation TimesDevices/Biologics.: An article from: Validation Times
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Bankrupt firm's successor tackles validation, facilities.(Brief Article): An article from: Inspection MonitorBankrupt firm's successor tackles validation, facilities.(Brief Article): An article from: Inspection Monitor
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Lack of acceptance criteria and validation flaws nets 6-item 483 for American I.V.: An article from: Validation TimesLack of acceptance criteria and validation flaws nets 6-item 483 for American I.V.: An article from: Validation Times by Joseph Pickett
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IPC aces Part 11 and validation corrections, picks up minor API infraction on re-inspection. (Human drugs).: An article from: Validation TimesIPC aces Part 11 and validation corrections, picks up minor API infraction on re-inspection. (Human drugs).: An article from: Validation Times
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Aventis dodges 483 despite validation protocol, Part 11 issues. (Human drugs).: An article from: Validation TimesAventis dodges 483 despite validation protocol, Part 11 issues. (Human drugs).: An article from: Validation Times
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Inadequate cleaning and packaging validation raise concerns at Sharp. (Human drugs).: An article from: Validation TimesInadequate cleaning and packaging validation raise concerns at Sharp. (Human drugs).: An article from: Validation Times
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Development of individualized medicines present validation challenges, FDA tells CASSS attendees.(Process validation): An article from: Validation TimesDevelopment of individualized medicines present validation challenges, FDA tells CASSS attendees.(Process validation): An article from: Validation Times by Joseph Pickett
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Holter monitor manufacturer's validation problems 'continual'. (Medical devices).: An article from: Validation TimesHolter monitor manufacturer's validation problems 'continual'. (Medical devices).: An article from: Validation Times
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Natural Technology's final validation likely to be extended into mid-'03. (Human drugs).: An article from: Validation TimesNatural Technology's final validation likely to be extended into mid-'03. (Human drugs).: An article from: Validation Times
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Cytogen receives 483 for validation violations.(Biologics/medical devices): An article from: Validation TimesCytogen receives 483 for validation violations.(Biologics/medical devices): An article from: Validation Times by Joseph Pickett
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In Silico Technologies in Drug Target Identification and Validation (Drug Discoveries Series)In Silico Technologies in Drug Target Identification and Validation (Drug Discoveries Series)
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Firms can give FDA validation protocol to avoid 3-lot hassles. (Process validation).: An article from: Validation TimesFirms can give FDA validation protocol to avoid 3-lot hassles. (Process validation).: An article from: Validation Times by Hilda Regier
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Analysis of 483s/EIRs for GMP validation issues : Human Drugs Contract Pharmacal hit for OTC drug validation.: An article from: Validation TimesAnalysis of 483s/EIRs for GMP validation issues : Human Drugs Contract Pharmacal hit for OTC drug validation.: An article from: Validation Times by Mark McCarty
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FDA challenges King on validation, complaint handling. (Human drugs).: An article from: Validation TimesFDA challenges King on validation, complaint handling. (Human drugs).: An article from: Validation Times
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Sterilization and sealing validation items top 483.(Brief Article)(Company Profile): An article from: Validation TimesSterilization and sealing validation items top 483.(Brief Article)(Company Profile): An article from: Validation Times
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Assay method validation, environmental monitoring hit with Abbott contracting.(Brief Article): An article from: Validation TimesAssay method validation, environmental monitoring hit with Abbott contracting.(Brief Article): An article from: Validation Times
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Red Cross validation and QA/QC leaves much to be desired, FDA said. (Blood & Biologics).: An article from: Validation TimesRed Cross validation and QA/QC leaves much to be desired, FDA said. (Blood & Biologics).: An article from: Validation Times
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Germiphene process validation inadequate.: An article from: Validation TimesGermiphene process validation inadequate.: An article from: Validation Times by Evelyn Heitman
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Nassmith's process validation, lab testing of OTC drugs cited.(over-the-counter)(Brief Article): An article from: Validation TimesNassmith's process validation, lab testing of OTC drugs cited.(over-the-counter)(Brief Article): An article from: Validation Times
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Responsibility for validation, distributor status nets TRF a warning letter. (Medical devices).: An article from: Validation TimesResponsibility for validation, distributor status nets TRF a warning letter. (Medical devices).: An article from: Validation Times
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Incomplete washing validation tests put ARJO in a sling. (Medical devices).: An article from: Validation TimesIncomplete washing validation tests put ARJO in a sling. (Medical devices).: An article from: Validation Times
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Valiteq Aseptic Technique Validation System: Compounding ManualValiteq Aseptic Technique Validation System: Compounding Manual by Marghi R. McKeon
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Validation of Cell-Based Assays in the GLP Setting: A Practical GuideValidation of Cell-Based Assays in the GLP Setting: A Practical Guide
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Software changes need validation in DMR, plasma association finds. (Blood & Biologics).: An article from: Validation TimesSoftware changes need validation in DMR, plasma association finds. (Blood & Biologics).: An article from: Validation Times
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Quintiles cited for validation, part 11 deficiencies.(Human drugs): An article from: Validation TimesQuintiles cited for validation, part 11 deficiencies.(Human drugs): An article from: Validation Times
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Poor validation, stability studies net Searle 10-item 483.: An article from: Validation TimesPoor validation, stability studies net Searle 10-item 483.: An article from: Validation Times by Tamra Sami
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Validation flaws and lack of instrument calibration net 9-item 483.(Human/animal drugs): An article from: Validation TimesValidation flaws and lack of instrument calibration net 9-item 483.(Human/animal drugs): An article from: Validation Times by Joseph Pickett
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GMP validation slips become theme in recent Lilly audits. (Human drugs).: An article from: Validation TimesGMP validation slips become theme in recent Lilly audits. (Human drugs).: An article from: Validation Times
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CDER puts QbD into practice; 'regulatory relief' incentive seen.(Quality-by-design): An article from: Validation TimesCDER puts QbD into practice; 'regulatory relief' incentive seen.(Quality-by-design): An article from: Validation Times by Bruce Flickinger
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Biopharmaceutical Process Validation (Biotechnology and Bioprocessing Series)Biopharmaceutical Process Validation (Biotechnology and Bioprocessing Series) by Gail Sofer
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Testing Computers Systems for FDA/MHRA Compliance (Computer Systems Validation Life Cycle Activities)Testing Computers Systems for FDA/MHRA Compliance (Computer Systems Validation Life Cycle Activities) by David Stokes
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Sysmex software validation MDRs, design cited by FDA. (Medical devices).: An article from: Validation TimesSysmex software validation MDRs, design cited by FDA. (Medical devices).: An article from: Validation Times
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AAI lacked validation data, evades 483.(Human drugs): An article from: Validation TimesAAI lacked validation data, evades 483.(Human drugs): An article from: Validation Times by Tamra Sami
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SOPs, design validation net letter for Shelhigh.: An article from: Validation TimesSOPs, design validation net letter for Shelhigh.: An article from: Validation Times by Gale Reference Team
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Pertussis toxin validation is N. American Vaccine issue. (Blood/Biologics).: An article from: Validation TimesPertussis toxin validation is N. American Vaccine issue. (Blood/Biologics).: An article from: Validation Times
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