John Robinson

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 bazigos animal rule and orphan drugs annex 11 annual product review annual reviews aoq api application application of risk management approval process aql concept asn aspects assessment ati ati curve attendant risks attribute data audit observatio audit observations audit or regulatory inspection audit preparation audit summary report auditing auditing analytical laboratories auditing computer systems auditors audits avoid 483 avoid 483s avoiding avoiding 483 observations avoiding fda 483 benchmark validation benefit from hazard analysis better science bimo inspectors binomial confidence intervals bioanalytical methods biologics biologics facility design biologics license application biometric signatures biomolecule stabilization theory biosimilars biotechnology bla bottleneck analysis breach notification compliance breach notification rules buffer capacity bulk freeze-drying bullet proof 510(k) bullet proof 510k bullet-proof capa business process management business process optimization c-gmps c=0 plans cac si method cac-si method calibration calibration out of tolerances canada cancer chemotherapeutics capa capa process capa processes capa program capa training capa trainings capa(s) capacity planning and risk management case studies cause and effect cdrh cdx/ivd regulatory framework ce and fda ce mark ce marking ce marking devices cer cfr 21 part 11 cfr part 11 compliance cgmp cgmp compliance audits cgmp data cgmp environment cgmp inspections cgmp regulations cgmp requirements cgmps change control systems charles v. gyecsek chemical testing chinmoy roy choked flow conditions cioms clause 9 clean room clean room qualification and operation cleaning cleanroom cleaning methods cleanroom management cleanroom training cleanrooms and controlled environments cleanrooms environments clearance clinical clinical compliance clinical data clinical evaluation reports clinical evaluations clinical evidence reports clinical investigation clinical investigations clinical management systems clinical quality systems clinical requirements clinical research clinical staff and 3rd party qualification clinical study closeout program clinical trail training clinical trial clinical trial directive clinical trial processes clinical trial staff clinical trial trainings clinical trials clinical trials for foods close out sessions close-out visit closed loop investigations closed-loop investigations cloud computing cmc cmc requirements cmd-specific requirements cmo coa cobit coc code of federal regulations combination products. combo commercialization companion diagnostic regulatory framework companion diagnostics comparing two sets of data competent authorities complaint complaint documentation complaint handling complaint handling system complaint management system compliance compliance excel spreadsheets compliance for electronic records compliance management compliance planning compliance processes compliance processes for life sciences compliance software compliance success compliance training compliance webinar computer system computer system validation computer systems validation computervalidation concepts of glp’s conference construct container closure systems contamination correlations contents contents requirement control controlled environments controlling endotoxin conventional foods corrective and preventive actions cosmetic act cost-effective cots software coulometric kark fischer titration coulometrickark fischer titration cpg manual cpk cpm creating rfps creation of vmp critical incident critical software issues cross agency interactions crystalline csv ctms current good manufacturing practices current regulatory situation curtailing microbial excursions cycle design da compliance training dan oleary david dills david nettleton de novo process dealing with portable devices and remote access decision points demonstrate process capability deploying design design control design controls design dossier design history file design history file (dhf) design history files design inputs design of experiments design outputs design plans design process design specification design validation design verification development of targeted therapeutics development scientists deviation management process - webinar by globalc deviation practice device changes device corrections device engineers device exemption device history file device history record device history records device identifier device labeling device manufacturers device master record device master record (dmr) device master records dhf dhf typical contents dhr dhr and tf diagnostic dietary ingredients dietary supplement dietary supplements disinfection dmf dmr documentation documentation formats documentation of verification dos and donts of fda dr. charlie sodano draft guidance dried products drug drug commercialization drug development process drug development programs drug manufacturing drug marketing drug master files drug reaction reporting drug safety drug safety and pharmacovigilance regulatory affa drugs / biologics dryer configuration dsc dshea e-records ec design-dossier certificate edwin l bills effective standard operating procedure efficient validation eir turbo database electronic records electronic signatures eliminate 483s ema emotional event empirical process endotoxin engineering management engineers ensuring integrity entropy environmental contamination issues equipment validation eres establish mitigations eu eu council directive 93/42/ec eu cta eu cta application eu gcp eu licensing plan eu mdd requirements eu mdd software v and v expectations eu medical device eu medical device directives eu medical devices eu regulations eu requirements eu technical file eu vigilance eu’s emphasis eu’s mdd euctd euctd and fda regulations eudralex references european clinical trial directive european union european vigilance system event events mumbai excel - sas excel for audit trails excel spread sheet training excel spreadsheet validation excel spreadsheets expectations facilities and &d factors regulatory failing fast fault tree fd&c act fd&c act or the act fda fda 101 fda 21 cfr part 11 fda 483 fda 483 laboratory operation fda 483 observations fda 483 observations. fda 483s fda amendment fda and eu fda and eu regulations fda and eu requirements fda and iso regulations fda approval process fda bimo inspection fda compliance fda compliance issues fda compliance training fda compliant practice fda considerations fda decision tree fda design fda device clearance fda draft guidance fda expectations fda form 483s fda good pharmacovigilance practices fda guidance fda guidance documents fda guideline fda guidelines fda hot buttons fda ind fda ind application fda inspection fda inspection process fda inspections fda inspectors fda investigational fda mandated recall fda medical device regulations fda qsr fda qsr training fda quality system inspection technique fda recent guidance documents fda records fda references fda regarding fda regulation fda regulations fda regulations guidance fda regulatory training fda regulatory webinars fda requirements fda sampling plans fda structure fda system fda training fda training. compliance fda trainings fda trains fda trends fda validation guidance fda vs. ftc fda warning fda warning letter fda warning letters fda’s fda’s 21 cfr 11 fda’s complaint fda’s current recommendations fda’s design regulations fda’s gxp fda’s request fda-ich q9 fdas fdas cgmp regulationssix systems inspection model fdas complaint fdas life cycle fdas mdrs fdas revised fdas strategic priorities fdm fim fim process financial health financial reporting financial risk management finished lyophilized product first in human fmea fmeca food foods form 483 form 483 audit formal project management format freeze-dryers freezing fsca fsn fta templates ftc ftc jurisdiction gamp/ispe gantt gcp gcp compliance gcp compliance audits gcp quality system general cgmp issues general 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 labeling issues labeling requirements laboratory compliance laboratory controls laboratory information management system laboratory water systems lalit hotel seminar leadership leadership position lean configuration lean documents lean-agile project management life science products life sciences life sciences manufacturing line training link requirements lipid based formulations lyophilization lyophilization cycle lyophilization cycles lyophilization process lyophilized products maintaining computer systems manage management management controls management responsibility for medical devices management tools. manufacturing manufacturing contamination control manufacturing training manufacturing trainings manufacturing’s water systems mapping market corrections in compliance marketing authorization holders markus weber master verification mdd 93 mdd 93/42/eec mdd annex x mdd directives mdr’s & recalls mdrs & recalls meddevs medical & surgical medical compliance medical device medical device compliance training medical device directive medical device directives medical device identification medical device labeling medical device manufacturers medical device manufacturers are required to repor medical device products medical device reporting medical device software development medical device supplier quality agreements medical device technical file medical device training medical device vigilance medical devices medical devices industry medical devicetraining medical products method validation methods of compliance mhra micro test method microbial microbial control microbial control measures microbial count correlates microbial enumeration myths microbial monitoring myths microbial sampling techniques microbial troubleshooting microbial validation microbiology lab microbiology laboratory supervisors misleading labeling mitigation architectures mitigation risk mitigation strategies and priorities mitigation validation monitoring mp training mumbai mumbai seminar mumbai seminars nanotechnology national drug code navigating nb audit focus nce nda nda and bla nda studies network qualification new chemical entity new draft guidance new fda inspections new regulatory audits nist objective base verification oc curve oecd oem relationships off label communication off label information off label promotion off-label information on site audit online online compliance training online compliance webinars online fda trainings online marketing online regulatory compliance online regulatory compliance training online regulatory compliance training online training online training.process verification and validatio online trainings online webinar online webinars ontamination control support ood laboratory practice regulations oos results operation operational qualification operations managers optimized formulations oq orphan drugs otc drugs outlet flushing outs of audit trail packaging and labeling packaging issues part 11 part 11 compliance part 11 inspections part 11 regulation part 11 regulations part 211 part 803 part 806 part 806 fda pat pc or qc pci training pci trainings pedigrees perceived performance matrix periodic safety pert pharma pharma consulting pharma covigilance pharmaceutical pharmaceutical compliance pharmaceutical compliance training pharmaceutical filings pharmaceutical industry pharmaceutical quality systems pharmaceutical supply chain pharmaceutical training pharmaceutical water system pharmaceutical water systems pharmaceuticals pharmacovigilance pharmacovigilance practices pharmacovigilance risk assessment phases i to iv pma pma submission portfolio optimization portfolio optimization model portfolio planning portfolio selection post authorization safety post design medical device post market surveillance post-validation postmarketing vigilance reporting potential 510(k) submissions powders pq practical applications pre ind studies pre-clinical studies preamendment devices precision preclinical testing predicate device predicate rulecomplying predicates preparation preventive maintenance primary proactive vendor management probabilistic approaches problem solving tools procedures process analytical technology process development process development and validation process equipment control process validation process validation life cycle approach process validation protocol preparation product claims product complaint investigations product complaint management system. product contaminations product hazard analysis product life cycle production engineers production engineers production management products used project management project structure projects prioritization proper documentation protocol submission protocols proven techniques psurs purified water systems pv reporting updates q10 focus q8 and q9 lessons q9 qa qa qc personnel qbd qca qms qrm qrm and quality systems qrm audit qrm results qrm team qrm tools qsit qsit inspection qsit manual qsr qsr and iso 13485 qsr and iso requirements qsr manual qsr regulations qsrs quality and iso 9000 compliance quality assurance quality assurance pharmacovigilance audit. quality assurance responsibilities quality control quality control assurance quality factors quality management system quality plan quality system quality system auditors quality system regulation quality system regulations quality systems quality systems-based approach quality tools quality training quality trainings r & d activities r and d r&d directors r&d engineers r&d engineers r&d management rac rac recertification raps rca real power real time release real-time systems recalls receipt to trending recent fda 483s recognizing red herringsoverview: aside from being records management registration procedures in eu regression analysis regulated environments regulated industries regulations and guidelines regulatory regulatory affairs regulatory affairs staff regulatory agency regulatory and compliance professionals regulatory aspects regulatory authorities regulatory changes regulatory chronology regulatory complaint regulatory compliance regulatory compliance requirements regulatory compliance training regulatory documents regulatory documents explained regulatory environment regulatory expectation regulatory expectations regulatory infrastructure regulatory inspection regulatory management regulatory master files regulatory matters regulatory obligations regulatory requirements regulatory review regulatory strategy regulatory structure in china regulatory structure in japan regulatory training remediation remote audits removal under part 806 report adverse events report complaints reporting requirements specification requirements traceability research research process residual moisture testing residual risk reusable device cleaning reusable medical review capa risk risk allocation of scarce resources risk analysis risk assessment risk based approach risk based approaches risk based monitoring risk based qualification risk based verification risk device risk identification risk management risk management activities risk management activities. risk management file post design risk management for compliance risk management life cycle risk management medical devices industry risk management models risk management planning risk management processes risk management tools risk management training risk mitigation risk mitigation strategies risk rating method risk statement risk-based software validation risk-based validation approach risks inherent decisions root cause analysis root cause of deviations root cause ofdeviations rql point safety assessments safety critical software safety of medical device safety perspectives sample size sample sizes for variables data sampling sampling inspection sampling plan sampling plans sarbanes oxley act sarbanes-oxley scale-up strategy scm sealed vials seminar seminar bangalore seminar bangalore.angela bazigos seminar boston seminar columbus.regulatory compliance seminar delhi seminar pennsylvania seminar san diego seminar san francisco seminar washington dc seminars seniorquality shutting alligator farm signal detection signatures single test results six sigma dmaic social media social media and privacy software lifecycle standard software of unknown providence software risk management software tools software v&v protocols software validation software validation planning sop sop for fda inspection sop for method validation sop revisions sop to 483 sops soup south korea healthcare system south korea’s healthcare system sox compliance sox compliance training sox compliances specifications spectroscopy method spreadsheet validation standard operating procedures standards standards compliance statistical aspects statistical concepts statistical pitfalls statistical procedures statistical process control statistical tools statistics statistics for qca statistics for the non-statistician statute sterilization sterilization validation steve jolley steven kuwahara steven s kuwahara strategic priorities stratified sampling streamlining quality assurance submission submission methods submit a 510(k) substantial equivalence successful 510k submission supplements vs. pharmaceuticals supplier audit program supplier evaluation supply chain supply chain considerations supply chain integrity supply chain management supply chain management. supply chain risk management supply chainrisks switching rules system thinking system validation tag along audits targeting tumors team effectiveness tech file and dossier technical design requirements technical file technical file (tf) technical file design dossier template forms test method test procedures testing testing protocols. tf tf and dd expected contents tf or dd expected contents the controls for outsourcing manufacturing and tes the lalti hotel seminar theory of constraints therapeutics there is usually no problem-solving guidance avail thermal characterization thermal characterization techniques tipping 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