Compliance Trainings

medical devices fda requirements 21 cfr part 820 fda compliance 21 cfr part 11 fda regulatory training hipaa iso 13485 compliance compliance trainings lean configuration quality system regulation fda validation requirements fda audits capa employee performance evaluation fda warning letters quality management system capa quality system design history file clinical trials 21 cfr 11 compliance pharma regulatory compliance hipaa violations health hipaa hipaa consultants health care compliance hipaa privacy and security hipaa compliant software healthcare webinars security health care healthcare compliance medical device regulatory compliance part 11 compliance medical devices manufacturers human resources regulatory compliance quality assurance compliance-financial-services compliance requirements compliance risk management program bank-compliance-training bank-regulatory-compliance finance-risk-management regulatory control requirements government compliance difficult discussions with employees handling difficult employees training difficult employee conversations managing difficult conversations workplace conflict training crucial conversations training difficult conversations training activities cgmp current good manufacturing practices fda quality system regulations design control documents records for manufacturing lean documents implementation of flsa flsa requirements human resource wages payroll human resources fair labor standards act supplemental pay and bonuses supplemental wages and payroll flsa rules supplemental wages supplemental pay procedures new usp chapter 1224 usp 1224 usp 1224 transfer usp guidance method transfer protocol transfer of analytical procedures fda guidance on method transfer guidance on writing job descriptions job descriptions job description & requirements job description guidance compliance job description how to prepare a job description human resources description hipaa privacy rule hipaa for healthcare professionals hipaa privacy standards hipaa regulations hipaa omnibus rule hipaa changes 2015 hipaa tool kit 2015 fda quality management system laboratory accreditation method selection method validation method verification human resources complaints human resource complaints human resources harassment human resources forms for employees employee training employee relations investigations employee claims employee complaint policy human resources for employees employee harassment policy drug safety data and signals big data pharmaceuticals medical device safety data big-data-regulations big-data-drug-discovery big data v. drug discovery big-data-management medical webinar regulatory requirements attribute sampling plans medical devices online medical device compliance aql variables sampling plans fda design controls compliance and enforcement gmp training iso 13485 regulations good manufacturing practices fda cfr part 820 gmp regulations spreadsheets fda compliance trainings metrology vocabulary concepts gage correlation fda statistical analysis gages gage r&r gage bias guard-banded specifications gage linearity 510k fda approval 510 k premarket notifications fda 510k clearance 510 k substantial equivalence 510 k regulatory framework 510 k policies fda 510k review process 510k submission 510 k program 510k consulting 510 k practices fda regulated mobile medical apps fda mobile app updates fda regulation of mobile apps fda mobile app medical app definition fda medical device labeling cybersecurity labeling claims leveraging gxp controls hipaa identifiers hipaa security gxp requirements gxp regulated establishments gxp hipaa requirements hipaa edi hipaa privacy hipaa compliance hipaa omnibus final rule patient health information gxp facilties hipaa inspection tipping point fda current guidance on 510(k) device modification k97-1 analysis new 510(k) submission medical device changes 510(k) device modifications 510(k) change analysis k97-1 new 510(k) filing current k-97-1 memorandum 510(k) design history files key regulatory documents device history records principles of lean documents dmr device master records medical products dhr dhf verifiable audit trails fda-regulations part 11 complaint computer systems system security protocols audit trails part 11 requirements employee performance compliance employment employee performance review system root cause analysis methods capa root cause analysis quality assurance fda capa system fda corrective action program capa fda rca root cause analysis fda inspection training fda 483 warning letters fda inspection observation process fda inspectional observations fda inspection operations fda warning letter fda 483 observations fda foreign inspections 21 cfr guidelines glp testing fda glp regulation 21 cfr clinical trials glp requirements glp regulations fda 21 cfr non clinical safety 21 cfr part 58 glp compliance nonclinical studies good laboratory practice regulations glp glp good laboratory practice coaching employees coaching employee performance employee performance coaching performance problems performance coaching employee coaching form performance coaching issues employee performance management performance problems of employees payroll pay plans compensation programs program payroll corporate financial resources employee pay programs pay programs human resources payroll employee pay hr and payroll fda audit federal regulations sop administration issues standard operating procedures federal regulation title 21 sop for regulatory affairs sop regulations federal regulation title 493 regulatory affairs sop sop tracking ich gcp system validation user acceptance testing running uat scripts clinical research computer system validation uat writing uat scripts project planning project management system project management steps regulatory compliance requirements computer validation computerized systems validation project management computer systems validation it management harassment and retaliation anti harassment training employee to employee harassment harassment prevention sexual harassment sexual harassment training employee rights harassment training for employees harassment policy workplace engagement employee harassment form employee harassment workplace harassment training harassment prevention training dq pq qms v&v iso 14971 product risk management factor robust verification and validation ich q9 recent regulatory requirements hazard analysis iq cgmp deficiencies astm e2500 equivalents diagnostic pharmaceutical oq fda's software v&v model fda medical device approval process pma approval requirements cgmp compliance medical devices compliance device master record medical design review device history record cgmp for medical devices medical device design verification ivds design transfer quality system regulations capa complaint files cgmp requirements medical device design validation hippa regulations hipaa compliance programs hippa security risk analysis medical records hippa privacy and security investigations hippa liabilities & risks hipaa risk analysis requirements hippa risk analysis hipaa rules hippa privacy risk analysis fda approval process combination product submissions office of combination products combination product designation submission combination product process fda combination product system performance appraisal process performance appraisal human resource training effective appraisals performance appraisal toolbox human resource professionals hr training online 510k fda fdasia medical device company mdufa i 510 k submission medical device submissions fda safety & innovation act mdufa iii medical instruments medical device regulatory pma submissions fda medical device approval fda pma medical devices suppliers fda approval for medical devices medical device companies pma clinical trial contract pharmaceutical trials medicine trials new drug trials drug trials patient compliance dos and donts of fda inspection fda inspection guidence fda inspection preparation emotional intelligence fda inspection medical device recall medical device firms health risk determinations clinical affairs fda authority fda enforcement action fda recall management spc fda spc fda training pharmaceutical quality control food quality control biologic manufacturing process r & d manufacturing fda mdr submission fda consultant statistical process control drug quality control clinical research compliance clinical protocol development clinical trial protocol global clinical trials clinical regulatory issues clinical trial compliance ich guidelines clinical trial development dos and don’ts of clinical trial procedures clinical research requirements acceptable clinical trial protocol compliance in clinical trials clinical trials for drugs importance of investigator-initiated trials human resources employee training investigator initiated trials drug clinical trials investigator deficiencies human subject protection spreadsheet validation fda fda compliance training 21 cfr 11 fda excel spreadsheet validation fda regulatory compliance fda validation fda cfr 11 fda part 11 validation guidance requirements for excel spreadsheets sample collection pharma regulatory affairs sample size fda regulatory consultant statistical precision statistical power statistical outsourcing services sampling plans sampling strategies drug regulatory affairs fda statistical analysis fda guidelines health care safety hipaa 5010 health care risks hipaa electronic medical records health and safety providers health care product health records privacy electronic health records healthcare privacy healthcare security hipaa therapy health information management quality health care agency health care organizations compliance healthcare health care regulatory compliance hipaa privacy and security rules healthcare safety health care omnibus breach health care information health care regulations healthcare hipaa hipaa privacy and securite update medical supplies and equipment medical regulatory compliance fda cfr 21 part 11 medical webinars medical devices regulatory quality system inspection techniques fda quality system regulation iso for medical devices iso 13485 medical devices medical products design biomedical device design medical device manufacturers canada medical device verification medical equiptment medical regulatory affairs medical device testing quality management quality control and tracking documentation excel 21 cfr spreadsheet design specifications hr strategy online teaching and learning 483s regulatory affairs webinar warning letters