Content tagged "mdd-annex-x"
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21 cfr part 11 compliance compliance training compliance webinar computer system validation device history file fda fda compliance training fda guidance fda regulatory webinars iso 1345 training iso 13485 medical compliance medical device compliance training online compliance webinars online regulatory compliance online regulatory compliance training online training pharmaceutical compliance training pharmaceutical training process validation regulatory compliance training regulatory training risk management validation plan warning letters more…
(risk-based approach 13485 2003 14971 requirements 2-day in-person seminar 2012 21 cfr part 820 21 cfr 11 21 cfr 11 compliance 21 cfr 11 compliance validated computerized system 21 cfr 211 21 cfr 807 21 cfr 807.92(a)(3) 21 cfr 812 21 cfr part 11 21 cfr part 11 and computer validation 21 cfr part 11 compliance of computer systems 21 cfr part 11 features 21 cfr part 11 requirements 21 cfr part 11 training 21 cfr part 58 21 cfr part 820 21 cfr §820.75 21cfr 21cfr part 211 483 warning letters 483s 5 whys 510(k) 510(k) submission 510(k) submissions 510k 510k premarket submission 510k premarket submissions 510k submissions a to z’s of microbial control acceptance criteria accounting reconciliations accuracy. ad hoc spreadsheet add-on inspections adverse event agency expectationsfda alligator farm amorphous amorphous components analysts responsible for water sampling analytical laboratories analytical method development analytical test results anchoring and compliance and dhr and q10 angela 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principles of software validationquality m global drug development global harmonization task force glp glp requirements glp studies glp training gmp gmp and regulatory expectations gmp compliance gmp documents gmp expectations gmp operations gmp phase 1 products gmp regulations gmp requirements gmp requirements fda gmp training gmp trainings good clinical practice good clinicalpractices good documentation practices good laboratory practice good laboratory practice (glp) good manufacturing practices good pharmacovigilance good pharmacovigilance practice governance gravimetric methods guarantee fda compliance gxp compliant gxp computer system validation gxp environments gxp preadsheet application gxp requirementstmf handling security patches handling systems hazard analysis hazard domains hazard domains content preview hazard evaluation strategies hazard identification hazard latency issues hazard source health canada and us fda) health training health trainings herbal products hipaa hipaa audits hipaa compliance hipaa privacy hipaa privacy rule principles hipaa privacy seminar hipaa regulations hipaa security hipaa security policies hipaa security rules hippa training honeymoon hot buttons hypothesis testing ich ich compliant ich gcp guidelines ich guides ich q7 ich q8 ich q8 - 11 ich q9 ich q9 process ich qseries iche6 guidelines ide identified 1058 observations iec 60601-1 third edition iec 62304 iec60601 iec62304 imp dossier impd implementation of vmp implementing import alerts importing and exporting medical devices improving constraint performance in compliance inc including iso 17025 ind ind application ind meetings ind products ind safety submissions ind studies india india seminar india seminars ins of audit trail inspections and audits insurance policy integrated supply chains integration testing interlocks and pass throughs internal audit program international compliance intervals on cpk introduction investigation complaint handling investigational investigational device exemption (ide) investigational medicinal product dossier investigational new drug application (ind) investigations investigations operations manual investigator iom ip handling iq iq protocols iql point irb oversight irb review iso 1345 training iso 13485 iso 13485 2003 iso 13485 design iso 13485 requirements iso 13485 training iso 13485 trainings iso 13485-specific requirements iso 13485: 2003 iso 13485:2003 iso 14644 training iso 14971 iso 14971 compliance iso 17025 iso 31000 iso 31000 or 31010 iso 31010 iso 9001 iso and regulatory agencies iso requirements iso standard 14644 iso standards iso14971 it control and pci it infrastructure it is critical to accurately interpret and underst it risk itil ivds japan regulatory filing requirements jeff kasoff jim sheldon dean john e lincoln k-97-1 kernels of water system key design considerations key factors kinetics of lethality pre-validation lab bench label inspection label integrity labeling labeling considerations 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point title 21 toc toxicology and pharmacokinetics traceability traceability matrix tracking training training departments trending analysis trouble free water quality troubleshooting of pharmaceutical water systems tumor bioenergetics types of phase 1 products typical security risks u.s. fda device clearance u.s. fda’s tougher supplier controls udis unique device identification us us conference us drug regulation us fda us fda training us seminar usfda usp chapters validate testing methods validated system validating validating cleaning & sterilization validating cleaning and sterilization validating excel validation validation challenges validation documents validation guidance validation life-cycle approach validation master plan validation of analytical methods validation of existing systems validation plan validation planning validation protocol validation reports validation specialists validation systems validations vendor audit vendor compliance verification verification & validation vigilance vitro diagnostic devices vmp volumetric karl fischer titration voluntary recall warning letter warning letters warning letters indicating warning letters.avoid 483 waste flow management water microbial excursions water sampling data water specifications water system water system biofilm control water system dilemma water system investigation water system sanitization water system validation webinar webinars where applicable.to achieve compliance and to rema wins wis work instructions xbrl z1.4 …less