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Select Course ID:	SELECT YOUR COURSEAV00 – Introduction to Drug Safety and Pharmacovigilance, An Abridged CourseAV01 – Drug Safety and Pharmacovigilance Professional Certification ProgramAV01A – Pharmacokinetics and Pharmacodynamics for ProfessionalsAV01B – Good Pharmacoepidemiology Practice Professional Certification ProgramAV02 – Introduction to Drug Safety and PharmacovigilanceCGMP01 – cGMP: Introduction to Good Manufacturing Practice for Medicinal ProductsCGMP01a – cGMP: What is GMP and Why is it Important (Fundamentals)CGMP01b – cGMP: The Principles of GMP (Fundamentals)CGMP01c – cGMP: Hygiene, Cleaning, and Sanitation (Fundamentals)CGMP01d – cGMP: Documentation and Record Keeping (Fundamentals)CGMP02 – cGMP: Good Documentation Practice (GDocP)CGMP03 – cGMP: Good Manufacturing Practice in Cleaning and SanitationCGMP04 – cGMP: Good Manufacturing Practice for the WarehouseCGMP05 – cGMP: Good Manufacturing Practice in Processing Medicinal ProductsCGMP06 – cGMP: Good Manufacturing Practice in Packaging Medicinal ProductsCGMP07 – cGMP: Corrective and Preventive Action (CAPA) in Medicinal Product Manufacturing – Including Root Cause AnalysisCP001a – DIGR-ACT® Solution: Critical Thinking Skills – Including Root Cause Analysis & CAPACP002a – GCP Training: ICH E6(R2)CP003a – GCP Refresher Training for the Experienced ProfessionalCP004a – ICH E6(R2) GCP Training for Investigator Site Personnel (Investigators and CRCs)CP005a – Good Documentation Practices and ALCOA-CCP006a – Corrective and Preventive Action (CAPA) Process Planning for Clinical Research ProfessionalsCP007a – CRO OversightCP008a – ISO 14155:2020 Medical Device StandardCP009a – The General Data Protection Regulation (GDPR) and Clinical TrialsCP010a – Medical Device vs. Drug: Comparing and ContrastingCP011a – Investigator Initiated Clinical TrialsCP012a – Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A)CP013a – Structure and Content of Clinical Study Reports (ICH E3)CP014a – Overview of 21 CFR Part 50 Human Subject Protection (HSP) and 21 CFR Part 56 IRB/IECCP015a – Overview of 21 CFR Part 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA)CP016a – Overview of 21 CFR Part 54 Financial Disclosure & Part 11 Electronic Data SignaturesCP017a – HIPAA Training for Clinical Trial ProfessionalsCP018a – Regulatory Requirements for Clinical Trials in Europe (Directive to Regulation)CP019a – Overview of ICH E8(R1): General Considerations for Clinical Studies GuidelineCP021a – Clinical Trial eSystems Inspection ReadinessCP022a – Good Clinical Practice Training (GCP): ICH E6(R3)CP023a – Major Changes in GCP from ICH E6(R2) to (R3): Road MapCRCPRO – Clinical Research Coordinator (CRC) Professional Certification ProgramCSA-101 – CSA: Computer Software AssuranceCSA-301 – Validation & Compliance: Commercial-off-the-shelf (COTS), Software-as-a-service (SaaS) and Cloud SystemsCSAPRO – Computer Software Assurance (CSA) Professional Certification ProgramCT03A – GCP: ICH, Harmonization, and Principles of GCP ICH E6(R3)CT03B – GCP: Clinical Research Teamwork (Fundamentals)CT03C – GCP: Clinical Trial GCP ICH E6(R3) Records and Data Governance (Fundamentals)CT03D – GCP: Clinical Trial Sponsors GCP ICH E6(R3) Responsibilities (Fundamentals)CT03E – GCP: Clinical Trial Investigators GCP ICH E6(R3) Responsibilities (Fundamentals)CT03F – GCP: Informed Consent in Clinical Trials (Fundamentals)CT03G – GCP: Clinical Trial Monitors GCP ICH E6(R3) Responsibilities (Fundamentals)CT04A – Clinical Trials in Drug Development (Fundamentals)CT04B – Clinical Trials: Protocol Design (Fundamentals)CT04C – Clinical Trials: Preparation (Fundamentals)CT04D – Clinical Trials: Endpoints (Fundamentals)CT04E – Clinical Trials: Statistical Elements (Fundamentals)CT04F – Clinical Trials: Study Design (Fundamentals)CT04G – Clinical Trials: Data Capture (Fundamentals)CT11 – Clinical Trials: How to Gain Authorization for Clinical Research Under the EU Clinical Trials RegulationCT12 – Clinical Trials: How to Conduct Clinical Research Under the EU Clinical Trials RegulationCT13 – Safety Reporting in Clinical Trials (Adverse Event Reporting)CT14 – Clinical Trial Safety Reporting Requirements in the EU and USAESR01A – Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures)GCP00 – ICH-GCP: Good Clinical Practice, An Abridged CourseGCP001 – GCP: ICH-GCP Good Clinical Practice E6(R3)GCP002 – Clinical Trials: Preparation and DesignGCP003 – Clinical Trials and Drug DevelopmentGCP004 – Clinical Trial Monitoring: Site Evaluation and Set-upGCP005 – Clinical Trial Monitoring: Documentation and ClosureGCP006 – Clinical Trials: Preparing for an Audit or InspectionGCP007 – Clinical Trials: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical TrialsGCP00A – Clinical Research Associate (CRA) Professional Certification ProgramGCP00A1 – Clinical Trials Management (US & EU) Professional Certification ProgramGCP00A2 – Regulatory Affairs for Clinical Research (US & EU) Professional Certification ProgramGCP020 – Clinical Trials: How to Obtain Approval to Conduct Clinical Trials in the EU GLP-101 – Introduction to Good Laboratory Practice (GLP)GLP-401 – GLP: Stability Testing ProgramsGLP-501 – GLP: Sampling PlansGLP01 – Good Laboratory Practice (GLP)GLP02 – G(QC)LP: Good Quality Control Laboratory PracticeGLPRO – Good Laboratory Practice (GLP) Professional Certification ProgramGMP00 – cGMP: Introduction to Good Manufacturing Practice, An Abridged CourseGMP001S1 – Current Good Manufacturing Practice (cGMP) Professional Certification ProgramGMP01 – cGMP: Introduction to Good Manufacturing Practice (GMP)GMP02 – cGMP: Warehouse for PharmaceuticalsGMP03 – cGMP: Microbiology in the WorkplaceGMP04 – cGMP: Cleaning and SanitationGMP05 – cGMP: Documentation and Record Keeping (GDocP)GMP06 – cGMP: Contamination ControlGMP07 – cGMP: Production ControlsGMP08 – cGMP: Packaging ControlsGMP09 – cGMP: Quality Assurance and Quality Control (QA/QC)GMP10 – cGMP: Pharmaceutical Corrective and Preventive Action (CAPA) – Including Root Cause AnalysisGMP11 – cGMP: Data IntegrityGMPF – GMP: Food Manufacturing for Professionals (21 CFR Part 117)GMPF0 – GMP Awareness for Food Industry Employees, An Abridged CourseGMPF01 – GMP Awareness: Food ManufacturingGMPF02 – GMP: Food Manufacturing Warning Letters and Case StudiesGMPF03 – GMP for Food Manufacturing: The Nine (9) Principles of 21 CFR Part 117GMPREF – GMP Refresher Program for ProfessionalsGXP01 – GxP: Good Practices (GxP) in Drug Development and ManufacturingHR-01 – HR/EEO: Preventing Harassment and Discrimination for EmployeesHR-02 – HR/EEO: Preventing Harassment and Discrimination for ManagersHR-03 – HR/EEO: Preventing Sexual Harassment for EmployeesHR-04 – HR/EEO: Preventing Sexual Harassment for ManagersICT02 – Assuring Data Integrity in the Manufacture of Medicinal ProductsICT03 – Assuring Data Integrity in Clinical ResearchMDA0 – Introduction to the Regulation of Medical DevicesOSHA-01 – OSHA: Bloodborne Pathogens for Healthcare WorkersOSHA-02 – OSHA: Chemical SafetyOSHA-03 – OSHA: Compressed Gas SafetyOSHA-04 – OSHA: Electrical Safety for HealthcareOSHA-05 – OSHA: Emergency Response PlanOSHA-06 – OSHA: Environmental Cleaning-Exam RoomsOSHA-07 – OSHA: Fire Safety and Emergency EvacuationOSHA-08 – OSHA: Flammable Liquid SafetyOSHA-09 – OSHA: Formaldehyde SafetyOSHA-10 – OSHA: Hand HygieneOSHA-11 – OSHA: Hazard Communications for HealthcareOSHA-12 – OSHA: Incident Reporting in HealthcareOSHA-13 – OSHA: Infection Control for Healthcare ProfessionalsOSHA-14 – OSHA: Laser SafetyOSHA-15 – OSHA: Latex AllergyOSHA-16 – OSHA: Lockout/Tagout Control of Hazardous EnergyOSHA-17 – OSHA: Patient Abuse & NeglectOSHA-18 – OSHA: Patient RightsOSHA-19 – OSHA: Personal Protective Equipment for Healthcare WorkersOSHA-20 – OSHA: Preventing Needlestick InjuriesOSHA-21 – OSHA: Preventing Workplace Violence in Healthcare SettingsOSHA-22 – OSHA: Radiation SafetyOSHA-23 – OSHA: Safe Patient HandlingOSHA-24 – OSHA: TB Protection for Healthcare WorkersOSHA-25 – OSHA: Active Shooter ResponseOSHA-26 – OSHA: Back Care/ErgonomicsOSHA-27 – OSHA: Laboratory SafetyOSHA-28 – OSHA: Slips, Trips & FallsOSHA-29 – OSHA: Violence in the WorkplaceOSHAPRO – OSHA for Healthcare ProfessionalsPKPD01 – Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and RegistrationPKPD02 – Conducting Pharmacokinetic and Pharmacodynamic StudiesPRA00A1 – Global Pharmaceutical Regulatory Affairs Professional Certification ProgramPRA00B1 – US Pharmaceutical Regulatory Affairs Professional Certification ProgramPRA01 – Regulatory Affairs: Essentials for Human Medicinal Products – EU and USPRA02 – Regulatory Affairs: Orphan Drug Application – EU and USPRA03 – Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) FormatPRA04 – Regulatory Affairs: Electronic Common Technical Document (eCTD)PRA05 – Regulatory Affairs: Registration of Drugs Based on Monoclonal AntibodiesPRA06 – Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the USAPRA07 – Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the USAPRA08 – Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USAPRA20 – Regulatory Affairs: The European Centralized Procedure (CP)PRA21 – Regulatory Affairs: The Mutual Recognition Procedure (MRP)PRA22 – Regulatory Affairs: Variations to Marketing Authorizations in EuropePRA23 – Regulatory Affairs: The Decentralized Procedure (DCP)PRA24 – Regulatory Affairs: Essentials of Monoclonal AntibodiesPV04 – Drug Safety: Signal Detection and Management in PharmacovigilancePV05 – Drug Safety: Risk Management Planning for Medicinal ProductsPV06 – Drug Safety: Urgent Safety RestrictionsPV07 – Drug Safety: Good Pharmacoepidemiology PracticeQRM-101 – Quality Risk Management (QRM): Accessing Risks in Daily OperationsSAM01 – Pharmaceutical Sales & Marketing: Legal and Regulatory Framework for Advertising and Promotion of Prescription Drugs in the USASAM02 – Pharmaceutical Sales & Marketing: Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USASAM03 – Pharmaceutical Sales & Marketing: Consumer-directed Advertising and Online Promotion of Prescription Drugs in the USASAM04 – Pharmaceutical Sales & Marketing: Marketing of Prescription Drugs in the USA- Interactions with Healthcare ProfessionalsSAMPRO – Pharmaceutical Sales & Marketing Compliance Professional CertificationSOP-101 – Standard Operating Procedures (SOPs) in the GxP Regulated IndustryVAL00S1 – Pharmaceutical Validation Management Professional Certification ProgramVAL00S2 – Computer System Validation for ProfessionalsVAL01 – Validation: Introduction to ValidationVAL02 – Validation: Plans and DocumentationVAL03 – Validation: Commissioning and Installation Qualification (IQ)VAL04 – Validation: Operational and Performance Qualification (OQ/PQ)VAL08 – Validation: Equipment Cleaning ValidationVAL09 – Validation: Computer System Validation (Part 1 of 2) (Planning)VAL10 – Validation: Computer System Validation (Part 2 of 2) (Implementation)
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