Download any of our FREE resources and White Papers!INVESTIGATIONS & CORRECTIVE AND PREVENTIVE ACTION (CAPA) WHITE PAPERS6 Ways to Identify Root Cause QuicklyCorrective Action or Correction- Which is it?Interview Skills For InvestigatorsBest Practices for Effectiveness Checks For CAPAAvoid Traps When Using the 5 Why'sOut of Specification (OOS) Investigations: Back To BasicsDoes Your Culture Need a CAPA?Establishing a Compliant and Risk Based CAPA SystemConducting InvestigationsWhy do we Have Repeat Investigations? It's OK To Document an Event Without Looking for Root CauseWhy Do We Triage? Examples of Conducting Investigations Why Trending is Important for RCA and Breakthrough ImprovementThree Key Statements for InvestigationsHow to Set Up Effectiveness ChecksSeven Things to Consider in Deviation InvestigationsCAPA Summaries7 Questions for Effectiveness ChecksWhy is Is Is NotStandard Work for Problem SolvingAdverse Event ReportingStandard Work for Problem SolvingNonconforming Materials Report: ExampleCapturing JustificationsNonconforming Materials ReportingThe Value of a Compliant, Effective, and Efficient CAPA SystemWrite Effective Root Cause Statements to Ensure Strong CAPAsOut of Tolerance Calibrations- Assessing the ImpactOut of Specification (OOS) Investigation ChecklistEffective Management of Supplier Corrective Action RequestsWhat to do about Human Error Deviations?TECHNICAL WRITING WHITE PAPERSTechnical Writing Style GuideWriting Documents from Different Perspectives and Managing Data in your ReportsMake Documents Easy for Your ReaderYour Good Documentation Practices (GDP) LegacyPlain Writing: It Works!Writing in a Cross Cultural Business EnvironmentHuman Factoring RecordsK.I.S.S. Your SOPs (Keep it Simple!...)Three Key Statements for InvestigationsWriting Effective Document Change Requests"How To" Guide for Managing Data in Your ReportsWrite Effective Root Cause Statements to Ensure Strong CAPAsWriting Effective Deviation InvestigationsBetter Writing Through Assessment ToolsALCOA: A Data Integrity StandardTRAINING WHITE PAPERSCoaching to Improve Training ResultsDo You Need a Trainer or a Training ConsultantBenefits of e-LearningHow to Source TrainingThe Advantages of Certifying In-House TrainersIs our Subject Matter Expert (SME) the right choice to become our in-house trainer?The Unlocked Potential of your Training ResourcescGMP Annual TrainingTo Train or Not to Train? In a Regulatory Inspection, How do you Justify Training?Qualification of Key RolesImplementing a Competency Based Training SystemThe Importance of Role Based Training &amp;amp;amp;lt;/p&amp;amp;amp;gt;<br />&amp;amp;amp;lt;div style=”display:inline;”&amp;amp;amp;gt;<br />&amp;amp;amp;lt;img height=”1″ width=”1″ style=”border-style:none;” alt=”” src=”//googleads.g.doubleclick.net/pagead/viewthroughconversion/1070776312/?value=0&amp;amp;amp;amp;amp;guid=ON&amp;amp;amp;amp;amp;script=0″/&amp;amp;amp;gt;&amp;amp;amp;lt;/div&amp;amp;amp;gt;<br />&amp;amp;amp;lt;p&amp;amp;amp;gt;REGULATORY AND COMPLIANCE INFORMATIONFDA Audit ExemptionsCurrent Regulatory Trends in the Area of Consent DecreesTop FDA 483 ObservationsInspectional Observation Trends for Medical DeviceChanging Regulatory Landscape: What Influenced the New EU MDRGuidance Document for industry and cGMP Requirements for Combination ProductsEU MDR 2017- Your Frequently Asked Questions AnsweredFDA Regulator Paths for Combination ProductsMarching to March-2019: ISO 13485:2016 Update Overview The MDSAP Program (In a Large Nutshell)Transition Planning Guide for ISO 13485:20168 Key Practices to aid in Board of Health (BOH) ResponsesSix Considerations for Good Clinical Practices (GCP) Quality Change Control White PapersIs Your Change Control System Under Control?Take ControlChange Control ClassificationsJustificationsManaging Changes Impacting DesignDocument Change Control- ExamplesGENERAL TOPIC WHITE PAPERSConducting Effective and Compliant ValidationsConducting Effective and Compliant Validations: An ExampleCapturing Justifications in Change Control, Risk Assessments, Validations, and InvestigationsComplaint HandlingThe False Claim Act: Sustained Use as the Government’s Primary Enforcement ToolKey Components of a Compliant Product Complaint Handling SystemInspectional Observation Trends for Medical DeviceHuman Performance ImprovementProper Execution of Annual Product ReviewsHuman Factoring RecordsThe PDCA cycle and Management System StandardsAchieving Success and Compliance in the Supply ChainDesign History Files – Design Control DocumentationDevice Master Records and Medical Device Files – How Do They Compare?The Impact Feedback Shares in Human Performance and FactoringDevice History Records – What Should They Include?The Power of Control ChartingWhat to do about Human Error Deviations?Design Transfer Success – From Product Development to ProductionThe Relentless Pursuit and Elimination of WasteThe Pilot Run ProcessThe Need For Capability AnalysisImplementation and Management of Data IntegrityIntroduction to Management ReviewsPostmarket Surveillance and FeedbackData VisualizationEffective Batch Record Review ProcessesMedical Device Classification and Applicable ControlsWriting Effective Document Change RequestsThe Importance of Evaluating your Measurement SystemCreating a Culture of Quality to Benefit ComplianceDon't Be (ONLY) Compliant!Making Your Kaizen Event a SuccessGuidelines for the Selection of a Proper Sampling PlanRisk Based Supplier QualificationUtilizing Simple Tasks for SuccessIs it Document Control or Document Management?Effective Batch Record Review PracticesDesign History Files – ExamplesManagement CommitmentAdverse Event ReportingEnvironmental MonitoringImplementing an Effective Return Material Authorization ProgramThe Importance of Equipment Maintenance in Assuring Product QualityThe Perception of QualityQUALITY RISK MANAGEMENT WHITE PAPERSThe commonalities between risk management and design verification, design validation and process validationValue in Risk ManagementHow Risk Management Tools Improve ProductRisk and Trending in Design ControlRisk Based Decision Making in a Quality SystemThe Need for Effective Risk ManagementEstablishing a Compliant and Risk- Based CAPA SystemRisk Based Supplier QualificationCapturing JustificationsMedical Device Risk ManagementISO TR 24971- What is this document and Why do I need it?Value in Risk ManagementHow to Perform a Successful Failure Modes and Effects AnalysisFMEA vs. FTAAUDITING WHITE PAPERSIn a Regulatory Inspection, How do You Justify TrainingMDSAP Program in a (large) NutshellPreparation for Hosting Third Party AuditsSix Steps to Plan and Conduct a Management System AuditAre You Ready? Prepare and Practice for Inspection Readiness!Supplier Audits- Conducting Desktop AuditsManaging Third Party Audits in a Regulated EnvironmentSupplier Audits: Keeping it SimpleWhat Team Do You Need in Place for an FDA Audit?Pre-Approval Inspection (PAI) OverviewAuditing ChecklistInterview Skills for InvestigatorsFDA Audit ExemptionsMDSAP- The Program that Came to StayAudit Checklist for Medical Devices and PharmaMDSAP Audit Preparation &amp;amp;lt;/p&amp;amp;gt;<br />&amp;amp;lt;div style=”display:inline;”&amp;amp;gt;<br />&amp;amp;lt;img height=”1″ width=”1″ style=”border-style:none;” alt=”” src=”//googleads.g.doubleclick.net/pagead/viewthroughconversion/1070776312/?value=0&amp;amp;amp;amp;guid=ON&amp;amp;amp;amp;script=0″/&amp;amp;gt;&amp;amp;lt;/div&amp;amp;gt;<br />&amp;amp;lt;p&amp;amp;gt;QUALITY SYSTEMS WHITE PAPERSFDA Quality Metrics Quick Reference GuideRequired and Optional Quality MetricsGlobal Quality Standards Implementation and Roll OutApplication of Codes for Quality Metrics ReportingContinuous Quality Improvement to Avoid RemediationEffective Quality System ManagementKeeping Good Quality RecordsQuality vs. Regulatory- Key Similarities and DifferencesHUMAN PERFORMANCE AND IMPROVEMENT4 Key Activities for Proactive Human Factoring of RecordsWhat to do about Human Error Deviations?The Impact Feedback Shares in Human Performance and FactoringWhite Paper: Human Performance ImprovementHuman Factoring Records Follow us! 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