Internationally Accredited Training Courses
Many of Biopharma Institute’s clinical research, regulatory affairs, cGMP, validation, and drug safety courses are internationally accredited by the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom, and offer Continuing Professional Development (CPD) points. On completion of each course, learners earn CPD points in proportion to the course’s duration. The CPD points earned are specified on the certificate awarded to the learner on successful completion of the course’s multiple-choice-question assessment. Below you will find a list of the courses which offer CPD points upon completion.
CME, CEU, and CPE Credits: Most credentialing centers in the US and abroad will transfer CPD points to units such as CME credits (for medical doctors), CEU credits (for nurses), or CPE credits (for pharmacists). However, we suggest you reach out to your local medical licensing board to confirm before purchasing the training if this is a desire. Each medical licensing board has different guidelines regarding the transfer of units.
Accredited Training Programs Offering CPD Credits:
- Change Control
- Clinical Trials Management and Monitoring
- Computer System Validation (CSV)
- Contamination Control
- Data Integrity
- Drug Safety
- Electronic Records
- Good Documentation Practices
- Good Laboratory Practices
- Good Manufacturing Practices
- Medical Devices
- Pharmaceutical Microbiology
- Pharmaceutical Regulatory Affairs
- Pharmaceutical Sales and Marketing
- Validation for BioPharma Companies
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Change Control – Regulations & GuidelinesCourse ID: ELM-159 |
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Change Control & Change ManagementCourse ID: ELM-160 |
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The Lifecycle of a Change Control Program – Phase 1: Develop the Change RequestCourse ID: ELM-161 |
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The Lifecycle of a Change Control Program – Phase 2: EvaluateCourse ID: ELM-178 |
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The Lifecycle of a Change Control Program – Phase 3: Implement Phase 4: ReviewCourse ID: ELM-179 |
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Examples of Change Controls, Documents & Recording Completed ChangesCourse ID: ELM-180 |
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GCP: ICH-GCP Good Clinical PracticeCourse ID: GCP001 |
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Clinical Trials: Preparation and DesignCourse ID: GCP002 |
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Clinical Trials and Drug DevelopmentCourse ID: GCP003 |
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ICH E6(R2) – Clinical Trial Protocol and Protocol Amendment (Chapter 6)Course ID: ELM-915 |
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ICH E6(R2) – Introduction and Principles of Good Clinical Practices (GCP) (Chapter 1-2)Course ID: ELM-904 |
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ICH E6(R2) – Institutional Review Board / Independent Ethics Committee (IRB/IEC) (Chapter 3)Course ID: ELM-924 |
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Clinical Trial Monitoring: Site Evaluation and Set-upCourse ID: GCP004 |
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Clinical Trial Monitoring: Documentation and ClosureCourse ID: GCP005 |
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Clinical Trials: Preparing for an Audit or InspectionCourse ID: GCP006 |
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Clinical Trials: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical TrialsCourse ID: GCP007 |
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Clinical Trials: How to Obtain Approval to Conduct Clinical Trials in the EUCourse ID: GCP020 |
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Clinical Trials: How to Gain Authorization for Clinical Research Under the EU Clinical Trials RegulationCourse ID: CT11 |
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Clinical Trials: How to Conduct Clinical Research Under the EU Clinical Trials RegulationCourse ID: CT12 |
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Clinical Trials: 21 CFR Part 50 Subpart B – Informed Consent of Human Subjects (HSP) [Part 1 of 2]Course ID: ELM-909 |
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Clinical Trials: 21 CFR Part 50 Subpart B – Informed Consent of Human Subjects (HSP) [Part 2 of 2]Course ID: ELM-910 |
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GCP: An Introduction to Good Clinical Practices – Part 1 of 3Course ID: ELM-901 |
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GCP: An Introduction to Good Clinical Practices – Part 2 of 3Course ID: ELM-902 |
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GCP: An Introduction to Good Clinical Practices – Part 3 of 3Course ID: ELM-903 |
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Validation: Computer System Validation (Part 1 of 2) (Planning)Course ID: VAL09 |
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Validation: Computer System Validation (Part 2 of 2) (Implementation)Course ID: VAL10 |
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Validation: Introduction to Software Validation (Part 1 of 2)Course ID: ELM-113 |
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Validation: Introduction to Software Validation (Part 2 of 2)Course ID: ELM-119 |
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Validation: The Life Cycle of a Software Validation ProtocolCourse ID: ELM-111 |
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Validation: Implementing Compliant Systems in the CloudCourse ID: ELM-118 |
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Validation: Managing and Ensuring Data Integrity of E-Records within a Regulated EnvironmentCourse ID: ELM-125 |
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CSV: Computer System Validation – Basic Concepts & GAMP®5Course ID: ELM-132 |
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CSV: Computer System Validation – The Regulated Software Life CycleCourse ID: ELM-133 |
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CSV: Computer System Validation – Requirements: The Basis for ValidationCourse ID: ELM-134 |
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CSV: Computer System Validation – Risk ManagementCourse ID: ELM-162 |
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CSV: Computer System Validation – The Master Validation Plan (MVP)Course ID: ELM-163 |
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CSV: Application of the Validation PlanCourse ID: ELM-164 |
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CSV: Validation Testing – Part 1Course ID: ELM-165A |
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CSV: Validation Testing – Part 2Course ID: ELM-165B |
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CSV: Maintaining the Validated StateCourse ID: ELM-166A |
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CSV: Supplier Provided SoftwareCourse ID: ELM-166B |
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CSV: Special TopicsCourse ID: ELM-167 |
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CSV: Periodic Review Strategies – Part 1Course ID: ELM-149A |
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CSV: Periodic Review Strategies – Part 2Course ID: ELM-149B |
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Introduction to Cleaning ValidationCourse ID: ELM-601 |
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Types of Contamination in a GMP EnvironmentCourse ID: ELM-701 |
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Sources of Contamination in a GMP EnvironmentCourse ID: ELM-702 |
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Contamination Prevention and Control – Quality Risk Management (QRM)Course ID: ELM-703 |
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Contamination Control Strategies in a GMP EnvironmentCourse ID: ELM-704 |
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The Basic Principles of Isolator TechnologyCourse ID: ELM-707 |
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Restricted Access Barrier Systems (RABS) Glove TrainingCourse ID: ELM-708 |
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Introduction to Endotoxin ControlCourse ID: ELM-709 |
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How Deviations (Non-Conformance) Should be Handled from a Regulatory PerspectiveCourse ID: ELM-712 |
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Pharmaceutical Contamination and MicroorganismsCourse ID: ELM-713 |
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Sources of Pharmaceutical ContaminationCourse ID: ELM-714 |
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The Use of Vaporized Hydrogen Peroxide (VHP) ChambersCourse ID: ELM-715 |
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Contamination Control Strategies in a GMP Environment: Cleaning and DisinfectionCourse ID: ELM-716 |
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GMP Contamination Control Strategies – PersonnelCourse ID: ELM-717 |
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GMP Contamination Control Strategies – Buildings and FacilitiesCourse ID: ELM-718 |
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Data Integrity: An Introduction to Data IntegrityCourse ID: ELM-148 |
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Data Integrity: Health Authority ExpectationsCourse ID: ELM-151 |
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Data Integrity: ALCOA and ALCOA+Course ID: ELM-152 |
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Data Integrity: Good Documentation Practice (GDocP)Course ID: ELM-153 |
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Data Integrity: Computer System Validation (CSV) Best PracticesCourse ID: ELM-154 |
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Data Integrity: Data GovernanceCourse ID: ELM-155 |
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Introduction to Drug Safety and PharmacovigilanceCourse ID: AV02 |
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Drug Safety: Signal Detection and Management in PharmacovigilanceCourse ID: PV04 |
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Drug Safety: Risk Management Planning for Medicinal ProductsCourse ID: PV05 |
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Drug Safety: Urgent Safety RestrictionsCourse ID: PV06 |
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Drug Safety: Good Pharmacoepidemiology PracticeCourse ID: PV07 |
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Safety Reporting in Clinical Trials (Adverse Event Reporting)Course ID: CT13 |
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Clinical Trial Safety Reporting Requirements in the EU and USACourse ID: CT14 |
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Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and RegistrationCourse ID: PKPD01 |
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Conducting Pharmacokinetic and Pharmacodynamic StudiesCourse ID: PKPD02 |
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Good Pharmacovigilance Practices (GVP): An Introduction to Pharmacovigilance and Adverse Drug ReactionCourse ID: ELM-920 |
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Good Pharmacovigilance Practices (GVP): Legal Framework of the Global Pharmacovigilance ProgramCourse ID: ELM-921 |
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Good Pharmacovigilance Practices (GVP): Updates to the European Union GVP GuidelinesCourse ID: ELM-922 |
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Good Pharmacovigilance Practices (GVP): Recent Inspections and Warning Letter Case StudiesCourse ID: ELM-923 |
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Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures)Course ID: ESR01A |
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21 CFR Part 11 – An IntroductionCourse ID: ELM-112 |
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21 CFR Part 11 – Electronic RecordsCourse ID: ELM-114 |
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21 CFR Part 11 – Electronic SignaturesCourse ID: ELM-115 |
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21 CFR Part 11 – 2003 GuidanceCourse ID: ELM-116 |
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Good Distribution Practices in Pharma (GDP) – Part 1Course ID: ELM-234 |
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Good Distribution Practices in Pharma (GDP) – Part 2Course ID: ELM-235 |
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Good Distribution Practices in Pharma (GDP) – Part 3Course ID: ELM-240 |
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GDocP: Good Documentation Practices and Data IntegrityCourse ID: ELM-104 |
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GDocP: Corrective Actions and Preventive Actions (CAPA) – Including Root Cause AnalysisCourse ID: ELM-117 |
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GDocP: How to Write Effective Standard Operating Procedures (SOPs)Course ID: ELM-126 |
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GDocP: How to Write an Effective Equipment User Requirement Specification (URS)Course ID: ELM-127 |
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GDocP: How to Manage Deviations in a GMP Environment – Part 1 of 2Course ID: ELM-130 |
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GDocP: How to Manage Deviations in a GMP Environment – Part 2 of 2Course ID: ELM-131 |
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GDocP: Good Documentation Practices – General Rules of Data IntegrityCourse ID: ELM-501 |
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GDocP: Good Documentation Practices – Making Correction to Ensure Data IntegrityCourse ID: ELM-502 |
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GDocP: Good Documentation Practices – Logbook Data IntegrityCourse ID: ELM-503 |
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GDocP: Good Documentation Practices – Data Integrity for General Test ResultsCourse ID: ELM-504 |
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GLP: An Introduction to Good Laboratory Practices (GLP)Course ID: ELM-101 |
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GLP: Laboratory Data Integrity and the Principles of ALCOA (GDocP)Course ID: ELM-102 |
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GLP: How to Prepare for Internal & External Laboratory AuditsCourse ID: ELM-106 |
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GLP: Laboratory Investigations & DeviationsCourse ID: ELM-108 |
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GLP: Performing Analytical Analysis in a Regulated LaboratoryCourse ID: ELM-109 |
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GLP: Organization, Roles and Infrastructure for Regulated or Accredited LaboratoriesCourse ID: ELM-110 |
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GLP: The Basics of Laboratory InvestigationsCourse ID: ELM-174 |
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GLP: How to Conduct a Laboratory InvestigationCourse ID: ELM-175 |
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GxP: Good Practices (GxP) in Drug Development and ManufacturingCourse ID: GXP01 |
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cGMP: Introduction to Good Manufacturing Practice for Medicinal ProductsCourse ID: CGMP01 |
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cGMP: Good Documentation Practice (GDocP)Course ID: CGMP02 |
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cGMP: Good Manufacturing Practice in Cleaning and SanitationCourse ID: CGMP03 |
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cGMP: Good Manufacturing Practice for the WarehouseCourse ID: CGMP04 |
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cGMP: Good Manufacturing Practice in Processing Medicinal ProductsCourse ID: CGMP05 |
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cGMP: Good Manufacturing Practice in Packaging Medicinal ProductsCourse ID: CGMP06 |
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cGMP: Corrective and Preventive Action (CAPA) in Medicinal Product Manufacturing – Including Root Cause AnalysisCourse ID: CGMP07 |
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GMP: Introduction to Good Manufacturing Practices (For Beginners)Course ID: ELM-722 |
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GMP: The Devastating Effects of Not Following cGMP (For Beginners)Course ID: ELM-710 |
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GMP: Good Manufacturing PracticesCourse ID: ELM-103 |
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GMP: Cases from History and the RegulationsCourse ID: ELM-201 |
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GMP: Good Manufacturing Practices – QMS, Premises and PersonnelCourse ID: ELM-202 |
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GMP: Equipment, Validation, Complaints and Self InspectionCourse ID: ELM-203 |
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GMP: Good Manufacturing Practices – Good Practices and Quality ControlCourse ID: ELM-204 |
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GMP: 21 CFR Part 211 Subpart B – Organization and PersonnelCourse ID: ELM-211 |
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GMP: 21 CFR Part 211 Subpart C – Building and FacilitiesCourse ID: ELM-205 |
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GMP: 21 CFR Part 211 Subpart D – EquipmentCourse ID: ELM-212 |
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GMP: 21 CFR Part 211 Subpart E – Control of Components, Drug Product Containers and ClosuresCourse ID: ELM-206 |
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GMP: 21 CFR Part 211 Subpart F – Production and Process ControlsCourse ID: ELM-208 |
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GMP: 21 CFR Part 211 Subpart G – Packaging and Labeling ControlCourse ID: ELM-209 |
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GMP: 21 CFR Part 211 Subpart H – Holding and DistributionCourse ID: ELM-207 |
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GMP: 21 CFR Part 211 Subpart J – Records and ReportsCourse ID: ELM-210 |
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GMP: 21 CFR Part 211 Subpart K – Returned and Salvaged Drug ProductsCourse ID: ELM-213 |
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GMP: Behavioral Based Quality (BBQ) for a GMP EnvironmentCourse ID: ELM-120 |
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GMP: Combination Products (Drugs, Devices and Biologics) – Part 1 of 3Course ID: ELM-145 |
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GMP: Combination Products (Drugs, Devices and Biologics) – Part 2 of 3Course ID: ELM-146 |
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GMP: Combination Products (Drugs, Devices and Biologics) – Part 3 of 3Course ID: ELM-147 |
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GMP: FDA Inspection Readiness- How to be an Effective GMP Auditor (Part 1 of 3)Course ID: ELM-122 |
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GMP: FDA Inspection Readiness- How to be an Effective GMP Auditor (Part 2 of 3)Course ID: ELM-123 |
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GMP: FDA Inspection Readiness- How to be an Effective GMP Auditor (Part 3 of 3)Course ID: ELM-124 |
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General GMP Inspection ReadinessCourse ID: ELM-190 |
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GMP Inspection Readiness: Your Role & Preparing for Inspector InteractionsCourse ID: ELM-191 |
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GMP: China Food and Drug Administration (CFDA) – GMP for Medical DevicesCourse ID: ELM-330 |
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GMP: China Food and Drug Administration (CFDA) – GMP for Implantable Medical DevicesCourse ID: ELM-331 |
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Quality Risk Management (QRM) – An Introduction to ICH Q9 – Part 1Course ID: ELM-232a |
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Quality Risk Management (QRM) – How QRM Applies to You and Regulations Review – Part 2Course ID: ELM-232b |
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MDSAP: Country Specific Requirements for BrazilCourse ID: ELM-141 |
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MDSAP: Country Specific Requirements for JapanCourse ID: ELM-144 |
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Introduction to the Regulation of Medical DevicesCourse ID: MDA0 |
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ISO 14971:2019 – The Scope of the StandardCourse ID: ELM-333 |
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ISO 14971:2019 – The Evolution and DefinitionsCourse ID: ELM-334 |
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ISO 14971: Basic Framework for Risk ManagementCourse ID: ELM-335 |
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ISO 14971: Characterizing the Device & Identifying HazardsCourse ID: ELM-336 |
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ISO 14971: Risk Analysis, Evaluation & ControlCourse ID: ELM-337 |
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ISO 14971: Different Perspectives of a Risk Management ProgramCourse ID: ELM-338 |
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ISO 13485:2016 – Chapter 1-3: IntroductionCourse ID: ELM-801 |
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ISO 13485:2016 – Chapter 4: The Quality Management System (QMS)Course ID: ELM-802 |
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ISO 13485:2016 – Chapter 5: Management ResponsibilityCourse ID: ELM-803 |
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ISO 13485:2016 – Chapter 6: Resource ManagementCourse ID: ELM-804 |
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ISO 13485:2016 – Product Realization (Chapter 7 – Part A)Course ID: ELM-805 |
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ISO 13485:2016 – Product Realization (Chapter 7 – Part B)Course ID: ELM-806 |
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ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part A)Course ID: ELM-807 |
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ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part B)Course ID: ELM-808 |
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GMP: 21 CFR Part 820 Subpart A – General ProvisionsCourse ID: ELM-301 |
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GMP: 21 CFR Part 820 Subpart B – Quality System Requirements (QSR)Course ID: ELM-302 |
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GMP: 21 CFR Part 820 Subpart C – Design ControlsCourse ID: ELM-303 |
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GMP: 21 CFR Part 820 Subpart D – Document ControlsCourse ID: ELM-304 |
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GMP: 21 CFR Part 820 Subpart E – Purchasing ControlsCourse ID: ELM-305 |
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GMP: 21 CFR Part 820 Subpart F – Identification and TraceabilityCourse ID: ELM-306 |
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GMP: 21 CFR Part 820 Subpart G – Production and Process ControlsCourse ID: ELM-307 |
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GMP: 21 CFR Part 820 Subpart H – Acceptance ActivitiesCourse ID: ELM-308 |
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GMP: 21 CFR Part 820 Subpart I – Nonconforming ProductsCourse ID: ELM-309 |
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GMP: 21 CFR Part 820 Subpart J – Corrective and Preventive ActionCourse ID: ELM-310 |
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GMP: 21 CFR Part 820 Subpart K – Labeling and Packaging ControlCourse ID: ELM-311 |
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GMP: 21 CFR Part 820 Subpart L – Handling, Storage, Distribution and InstallationCourse ID: ELM-312 |
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GMP: 21 CFR Part 820 Subpart M – RecordsCourse ID: ELM-313 |
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GMP: 21 CFR Part 820 Subpart N – ServicingCourse ID: ELM-314 |
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GMP: 21 CFR Part 820 Subpart O – Statistical TechniquesCourse ID: ELM-315 |
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EU MDR: EU Medical Device Regulation – IntroductionCourse ID: ELM-316 |
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EU MDR: EU Medical Device Regulation – Chapters 1 to 5Course ID: ELM-327 |
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EU MDR: EU Medical Device Regulation – Chapter 1: Scope and DefinitionsCourse ID: ELM-317 |
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EU MDR: EU Medical Device Regulation – Chapter 2: Making Available on the MarketCourse ID: ELM-318 |
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EU MDR: EU Medical Device Regulation – Chapter 3: Identification, Traceability and Registration of DevicesCourse ID: ELM-319 |
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EU MDR: EU Medical Device Regulation – Chapter 4: Notified BodiesCourse ID: ELM-320 |
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EU MDR: EU Medical Device Regulation – Chapter 5: Classification and ConformityCourse ID: ELM-321 |
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EU MDR: EU Medical Device Regulation – Chapters 6 to 10Course ID: ELM-328 |
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EU MDR: EU Medical Device Regulation – Chapter 6: Clinical Evaluation and Clinical InvestigationsCourse ID: ELM-322 |
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EU MDR: EU Medical Device Regulation – Chapter 7: Post Market Surveillance, Vigilance and Market SurveillanceCourse ID: ELM-323 |
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EU MDR: EU Medical Device Regulation – Chapter 8: Cooperation Between Member States, Medical Device Coordination Group, Expert Laboratories, etc.Course ID: ELM-324 |
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EU MDR: EU Medical Device Regulations – Chapter 10: Final ProvisionsCourse ID: ELM-326 |
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MDSAP: Medical Device Single Audit Program – Part 1 of 3Course ID: ELM-135 |
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MDSAP: Medical Device Single Audit Program – Part 2 of 3Course ID: ELM-136 |
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MDSAP: Medical Device Single Audit Program – Part 3 of 3Course ID: ELM-137 |
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MDSAP: Medical Device Single Audit Program – Chapters 1 to 4Course ID: ELM-138 |
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MDSAP: Medical Device Single Audit Program – Chapters 5 to 7Course ID: ELM-139 |
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MDSAP: Country Specific Requirements for USACourse ID: ELM-143 |
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MDSAP: Country Specific Requirements for CanadaCourse ID: ELM-142 |
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MDSAP: Country Specific Requirements for AustraliaCourse ID: ELM-140 |
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Pharmaceutical Microbiology and Industry ConsiderationsCourse ID: ELM-711 |
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Microbiological Testing MethodsCourse ID: ELM-721 |
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Microbial Contamination of Pharmaceutical Products – Part 1Course ID: ELM-705 |
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Microbial Contamination of Pharmaceutical Products – Part 2Course ID: ELM-706 |
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Control of Microbiological Contamination in a GMP EnvironmentCourse ID: ELM-720 |
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Microbiological Environmental MonitoringCourse ID: ELM-719 |
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Regulatory Affairs: Essentials for Human Medicinal Products – EU and USCourse ID: PRA01 |
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Regulatory Affairs: Orphan Drug Application – EU and USCourse ID: PRA02 |
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Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) FormatCourse ID: PRA03 |
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Regulatory Affairs: Electronic Common Technical Document (eCTD)Course ID: PRA04 |
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Regulatory Affairs: Registration of Drugs Based on Monoclonal AntibodiesCourse ID: PRA05 |
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Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the USCourse ID: PRA06 |
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Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the USCourse ID: PRA07 |
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Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USACourse ID: PRA08 |
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Regulatory Affairs: The European Centralized Procedure (CP)Course ID: PRA20 |
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Regulatory Affairs: The Mutual Recognition Procedure (MRP)Course ID: PRA21 |
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Regulatory Affairs: Variations to Marketing Authorizations in EuropeCourse ID: PRA22 |
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Regulatory Affairs: The Decentralized Procedure (DCP)Course ID: PRA23 |
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Regulatory Affairs: Essentials of Monoclonal AntibodiesCourse ID: PRA24 |
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Pharmaceutical Sales & Marketing: Legal and Regulatory Framework for Advertising and Promotion of Prescription Drugs in the USACourse ID: SAM01 |
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Pharmaceutical Sales & Marketing: Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USACourse ID: SAM02 |
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Pharmaceutical Sales & Marketing: Consumer-directed Advertising and Online Promotion of Prescription Drugs in the USACourse ID: SAM03 |
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Pharmaceutical Sales & Marketing: Marketing of Prescription Drugs in the USA- Interactions with Healthcare ProfessionalsCourse ID: SAM04 |
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Validation: Introduction to ValidationCourse ID: VAL01 |
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Validation: Plans and DocumentationCourse ID: VAL02 |
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Validation: Commissioning and Installation Qualification (IQ)Course ID: VAL03 |
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Validation: Operational and Performance Qualification (OQ/PQ)Course ID: VAL04 |
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Validation: Equipment Cleaning ValidationCourse ID: VAL08 |
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Process Validation: Introduction to Process Validation – Part 1 of 2Course ID: ELM-401 |
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Process Validation: Introduction to Process Validation – Part 2 of 2Course ID: ELM-402 |
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MedDev: Introduction to Medical Device Validation (Part 1 of 3)Course ID: ELM-156 |
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MedDev: Introduction to Medical Device Validation (Part 2 of 3)Course ID: ELM-157 |
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MedDev: Introduction to Medical Device Validation (Part 3 of 3)Course ID: ELM-158 |
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Equipment Validation: How to Perform Supplier QualificationCourse ID: ELM-107 |
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Equipment Validation: Introduction to Risk Based Equipment QualificationCourse ID: ELM-121 |
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Equipment Validation: How to Perform a Failure Mode Effect Analysis (FMEA) – Part 1Course ID: ELM-128 |
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Equipment Validation: How to Perform a Failure Mode Effect Analysis (FMEA) – Part 2Course ID: ELM-129 |
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Commissioning, Qualification & Validation: The Concept of CQV – Part 1Course ID: ELM-181 |
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Commissioning, Qualification & Validation: The Concept of CQV – Part 2Course ID: ELM-182 |
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Commissioning, Qualification & Validation: The Concept of CQV – Part 3Course ID: ELM-183 |
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