SCORM-Compliant Courses for Delivery from Your LMS
Each course is designed to deliver an engaging learning experience, complete with professional voiceovers, interactive activities, and a final assessment to reinforce mastery of the material.
With more than 100 courses organized by category, Biopharma Institute offers a comprehensive selection of up-to-date training programs.
- GCP: Clinical Trials Management and Monitoring
- CSV: Computer System Validation
- Drug Safety & Pharmacovigilance
- CFR Part 11: Electronic Signatures & Records
- GMP for Food Manufacturing
- GMP for Pharmaceuticals
- Medical Device Regulatory Affairs
- OSHA and EEO
- Pharmaceutical Regulatory Affairs
- Pharmaceutical Sales and Marketing
- Validation for GxP Compliant Companies
Contact us if you are interested in hosting our courses from your LMS for group training. We cater to all size opportunities.
Clinical Trials Management and Monitoring
|
|
![]() |
GCP: ICH-GCP Good Clinical Practice E6(R3)Course ID: GCP001 |
![]() |
Clinical Trials: Preparation and DesignCourse ID: GCP002 |
![]() |
Clinical Trials and Drug DevelopmentCourse ID: GCP003 |
![]() |
Clinical Trial Monitoring: Site Evaluation and Set-upCourse ID: GCP004 |
![]() |
Clinical Trial Monitoring: Documentation and ClosureCourse ID: GCP005 |
![]() |
Clinical Trials: Preparing for an Audit or InspectionCourse ID: GCP006 |
![]() |
Clinical Trials: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical TrialsCourse ID: GCP007 |
![]() |
Clinical Trials: How to Obtain Approval to Conduct Clinical Trials in the EUCourse ID: GCP020 |
![]() |
Clinical Trials: How to Gain Authorization for Clinical Research Under the EU Clinical Trials RegulationCourse ID: CT11 |
![]() |
Clinical Trials: How to Conduct Clinical Research Under the EU Clinical Trials RegulationCourse ID: CT12 |
![]() |
Good Clinical Practice Training (GCP): ICH E6(R3)Course ID: CP022a |
![]() |
Major Changes in GCP from ICH E6(R2) to (R3): Road MapCourse ID: CP023a |
![]() |
DIGR-ACT® Solution: Critical Thinking Skills – Including Root Cause Analysis & CAPACourse ID: CP001a |
![]() |
Critical Thinking for Clinical Research ProfessionalsCourse ID: CP020a |
![]() |
GCP Training: ICH E6(R2)Course ID: CP002a |
![]() |
GCP Refresher Training for the Experienced ProfessionalCourse ID: CP003a |
![]() |
ICH E6(R2) GCP Training for Investigator Site Personnel (Investigators and CRCs)Course ID: CP004a |
![]() |
Overview of ICH E8(R1): General Considerations for Clinical Studies GuidelineCourse ID: CP019a |
![]() |
Good Documentation Practices and ALCOA-CCourse ID: CP005a |
![]() |
Corrective and Preventive Action (CAPA) Process Planning for Clinical Research ProfessionalsCourse ID: CP006a |
![]() |
CRO OversightCourse ID: CP007a |
![]() |
ISO 14155:2020 Medical Device StandardCourse ID: CP008a |
![]() |
Medical Device vs. Drug: Comparing and ContrastingCourse ID: CP010a |
![]() |
Investigator Initiated Clinical TrialsCourse ID: CP011a |
![]() |
Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A)Course ID: CP012a |
![]() |
Structure and Content of Clinical Study Reports (ICH E3)Course ID: CP013a |
![]() |
Overview of 21 CFR Part 50 Human Subject Protection (HSP) and 21 CFR Part 56 IRB/IECCourse ID: CP014a |
![]() |
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)Course ID: CP015a |
![]() |
Overview of 21 CFR Part 54 Financial Disclosure & Part 11 Electronic Data SignaturesCourse ID: CP016a |
![]() |
Regulatory Requirements for Clinical Trials in Europe (Directive to Regulation)Course ID: CP018a |
![]() |
HIPAA Training for Clinical Trial ProfessionalsCourse ID: CP017a |
![]() |
The General Data Protection Regulation (GDPR) and Clinical TrialsCourse ID: CP009a |
![]() |
Clinical Trial eSystems Inspection ReadinessCourse ID: CP021a |
![]() |
GCP Refresher Training: ICH E6(R3)Course ID: CP024a |
![]() |
Clinical Trials in Drug Development (Fundamentals)Course ID: CT04A |
![]() |
Clinical Trials: Protocol Design (Fundamentals)Course ID: CT04B |
![]() |
Clinical Trials: Preparation (Fundamentals)Course ID: CT04C |
![]() |
Clinical Trials: Endpoints (Fundamentals)Course ID: CT04D |
![]() |
Clinical Trials: Statistical Elements (Fundamentals)Course ID: CT04E |
![]() |
Clinical Trials: Study Design (Fundamentals)Course ID: CT04F |
![]() |
Clinical Trials: Data Capture (Fundamentals)Course ID: CT04G |
![]() |
GCP: ICH, Harmonization, and Principles of GCP ICH E6(R3)Course ID: CT03A |
![]() |
GCP: Clinical Research Teamwork (Fundamentals)Course ID: CT03B |
![]() |
GCP: Clinical Trial GCP ICH E6(R3) Records and Data Governance (Fundamentals)Course ID: CT03C |
![]() |
GCP: Clinical Trial Sponsors GCP ICH E6(R3) Responsibilities (Fundamentals)Course ID: CT03D |
![]() |
GCP: Clinical Trial Investigators GCP ICH E6(R3) Responsibilities (Fundamentals)Course ID: CT03E |
![]() |
GCP: Informed Consent in Clinical Trials (Fundamentals)Course ID: CT03F |
![]() |
GCP: Clinical Trial Monitors GCP ICH E6(R3) Responsibilities (Fundamentals)Course ID: CT03G |
Computer System Validation (CSV)
|
|
![]() |
CSA: Computer Software AssuranceCourse ID: CSA-101 |
![]() |
Validation: Computer System Validation (Part 1 of 2) (Planning)Course ID: VAL09 |
![]() |
Validation: Computer System Validation (Part 2 of 2) (Implementation)Course ID: VAL10 |
Drug Safety
|
|
![]() |
Introduction to Drug Safety and PharmacovigilanceCourse ID: AV02 |
![]() |
Drug Safety: Signal Detection and Management in PharmacovigilanceCourse ID: PV04 |
![]() |
Drug Safety: Risk Management Planning for Medicinal ProductsCourse ID: PV05 |
![]() |
Drug Safety: Urgent Safety RestrictionsCourse ID: PV06 |
![]() |
Drug Safety: Good Pharmacoepidemiology PracticeCourse ID: PV07 |
![]() |
Safety Reporting in Clinical Trials (Adverse Event Reporting)Course ID: CT13 |
![]() |
Clinical Trial Safety Reporting Requirements in the EU and USACourse ID: CT14 |
![]() |
Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and RegistrationCourse ID: PKPD01 |
![]() |
Conducting Pharmacokinetic and Pharmacodynamic StudiesCourse ID: PKPD02 |
Electronic Records
|
|
![]() |
Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures)Course ID: ESR01A |
![]() |
Assuring Data Integrity in the Manufacture of Medicinal ProductsCourse ID: ICT02 |
![]() |
Assuring Data Integrity in Clinical ResearchCourse ID: ICT03 |
GMP for Dietary Supplement Manufacturing
|
|
![]() |
cGMPs for Dietary Supplements (21 CFR Part 111)Course ID: GMPDS |
GMP for Food Manufacturing
|
|
![]() |
GMP Awareness: Food ManufacturingCourse ID: GMPF01 |
![]() |
GMP: Food Manufacturing Warning Letters and Case StudiesCourse ID: GMPF02 |
![]() |
GMP for Food Manufacturing: The Nine (9) Principles of 21 CFR Part 117Course ID: GMPF03 |
Good Laboratory Practices
|
|
![]() |
Good Laboratory Practice (GLP)Course ID: GLP01 |
![]() |
G(QC)LP: Good Quality Control Laboratory PracticeCourse ID: GLP02 |
![]() |
Good Clinical Laboratory Practice (GCLP)Course ID: GLP03 |
![]() |
Introduction to Good Laboratory Practice (GLP)Course ID: GLP-101 |
![]() |
GLP: Stability Testing ProgramsCourse ID: GLP-401 |
![]() |
GLP: Sampling PlansCourse ID: GLP-501 |
Good Manufacturing Practices
|
|
![]() |
GxP: Good Practices (GxP) in Drug Development and ManufacturingCourse ID: GXP01 |
![]() |
Standard Operating Procedures (SOPs) in the GxP Regulated IndustryCourse ID: SOP-101 |
![]() |
Quality Risk Management (QRM ICH-Q9): Accessing Risks in Daily OperationsCourse ID: QRM-101 |
![]() |
cGMP: Introduction to Good Manufacturing Practice (GMP)Course ID: GMP01 |
![]() |
cGMP: Warehouse for PharmaceuticalsCourse ID: GMP02 |
![]() |
cGMP: Microbiology in the WorkplaceCourse ID: GMP03 |
![]() |
cGMP: Cleaning and SanitationCourse ID: GMP04 |
![]() |
cGMP: Documentation and Record Keeping (GDocP)Course ID: GMP05 |
![]() |
cGMP: Contamination ControlCourse ID: GMP06 |
![]() |
cGMP: Production ControlsCourse ID: GMP07 |
![]() |
cGMP: Packaging ControlsCourse ID: GMP08 |
![]() |
cGMP: Quality Assurance and Quality Control (QA/QC)Course ID: GMP09 |
![]() |
cGMP: Pharmaceutical Corrective and Preventive Action (CAPA) – Including Root Cause AnalysisCourse ID: GMP10 |
![]() |
cGMP: Data IntegrityCourse ID: GMP11 |
![]() |
cGMP: Introduction to Good Manufacturing Practice for Medicinal ProductsCourse ID: CGMP01 |
![]() |
cGMP: Good Documentation Practice (GDocP)Course ID: CGMP02 |
![]() |
cGMP: Good Manufacturing Practice in Cleaning and SanitationCourse ID: CGMP03 |
![]() |
cGMP: Good Manufacturing Practice for the WarehouseCourse ID: CGMP04 |
![]() |
cGMP: Good Manufacturing Practice in Processing Medicinal ProductsCourse ID: CGMP05 |
![]() |
cGMP: Good Manufacturing Practice in Packaging Medicinal ProductsCourse ID: CGMP06 |
![]() |
cGMP: Corrective and Preventive Action (CAPA) in Medicinal Product Manufacturing – Including Root Cause AnalysisCourse ID: CGMP07 |
![]() |
cGMP: What is GMP and Why is it Important (Fundamentals)Course ID: CGMP01a |
![]() |
cGMP: The Principles of GMP (Fundamentals)Course ID: CGMP01b |
![]() |
cGMP: Hygiene, Cleaning, and Sanitation (Fundamentals)Course ID: CGMP01c |
![]() |
cGMP: Documentation and Record Keeping (Fundamentals)Course ID: CGMP01d |
Medical Devices
|
|
![]() |
Introduction to the Regulation of Medical DevicesCourse ID: MDA0 |
![]() |
Quality Management System Requirements for Medical Devices under ISO 13485:2016 and FDA QMSRCourse ID: MD02 |
OSHA and EEO
|
|
![]() |
OSHA: Bloodborne Pathogens for Healthcare WorkersCourse ID: OSHA-01 |
![]() |
OSHA: Chemical SafetyCourse ID: OSHA-02 |
![]() |
OSHA: Compressed Gas SafetyCourse ID: OSHA-03 |
![]() |
OSHA: Electrical Safety for HealthcareCourse ID: OSHA-04 |
![]() |
OSHA: Emergency Response PlanCourse ID: OSHA-05 |
![]() |
OSHA: Environmental Cleaning-Exam RoomsCourse ID: OSHA-06 |
![]() |
OSHA: Fire Safety and Emergency EvacuationCourse ID: OSHA-07 |
![]() |
OSHA: Flammable Liquid SafetyCourse ID: OSHA-08 |
![]() |
OSHA: Formaldehyde SafetyCourse ID: OSHA-09 |
![]() |
OSHA: Hand HygieneCourse ID: OSHA-10 |
![]() |
OSHA: Hazard Communications for HealthcareCourse ID: OSHA-11 |
![]() |
OSHA: Incident Reporting in HealthcareCourse ID: OSHA-12 |
![]() |
OSHA: Infection Control for Healthcare ProfessionalsCourse ID: OSHA-13 |
![]() |
OSHA: Laser SafetyCourse ID: OSHA-14 |
![]() |
OSHA: Latex AllergyCourse ID: OSHA-15 |
![]() |
OSHA: Lockout/Tagout Control of Hazardous EnergyCourse ID: OSHA-16 |
![]() |
OSHA: Patient Abuse & NeglectCourse ID: OSHA-17 |
![]() |
OSHA: Patient RightsCourse ID: OSHA-18 |
![]() |
OSHA: Personal Protective Equipment for Healthcare WorkersCourse ID: OSHA-19 |
![]() |
OSHA: Preventing Needlestick InjuriesCourse ID: OSHA-20 |
![]() |
OSHA: Preventing Workplace Violence in Healthcare SettingsCourse ID: OSHA-21 |
![]() |
OSHA: Radiation SafetyCourse ID: OSHA-22 |
![]() |
OSHA: Safe Patient HandlingCourse ID: OSHA-23 |
![]() |
OSHA: TB Protection for Healthcare WorkersCourse ID: OSHA-24 |
![]() |
OSHA: Active Shooter ResponseCourse ID: OSHA-25 |
![]() |
OSHA: Back Care/ErgonomicsCourse ID: OSHA-26 |
![]() |
OSHA: Laboratory SafetyCourse ID: OSHA-27 |
![]() |
OSHA: Slips, Trips & FallsCourse ID: OSHA-28 |
![]() |
OSHA: Violence in the WorkplaceCourse ID: OSHA-29 |
![]() |
HR/EEO: Preventing Harassment and Discrimination for EmployeesCourse ID: HR-01 |
![]() |
HR/EEO: Preventing Harassment and Discrimination for ManagersCourse ID: HR-02 |
![]() |
HR/EEO: Preventing Sexual Harassment for EmployeesCourse ID: HR-03 |
![]() |
HR/EEO: Preventing Sexual Harassment for ManagersCourse ID: HR-04 |
Pharmaceutical Regulatory Affairs
|
|
![]() |
Regulatory Affairs: Essentials for Human Medicinal Products – EU and USCourse ID: PRA01 |
![]() |
Regulatory Affairs: Orphan Drug Application – EU and USCourse ID: PRA02 |
![]() |
Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) FormatCourse ID: PRA03 |
![]() |
Regulatory Affairs: Electronic Common Technical Document (eCTD)Course ID: PRA04 |
![]() |
Regulatory Affairs: Registration of Drugs Based on Monoclonal AntibodiesCourse ID: PRA05 |
![]() |
Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the USACourse ID: PRA06 |
![]() |
Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the USACourse ID: PRA07 |
![]() |
Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USACourse ID: PRA08 |
![]() |
Regulatory Affairs: The European Centralized Procedure (CP)Course ID: PRA20 |
![]() |
Regulatory Affairs: The Mutual Recognition Procedure (MRP)Course ID: PRA21 |
![]() |
Regulatory Affairs: Variations to Marketing Authorizations in EuropeCourse ID: PRA22 |
![]() |
Regulatory Affairs: The Decentralized Procedure (DCP)Course ID: PRA23 |
![]() |
Regulatory Affairs: Essentials of Monoclonal AntibodiesCourse ID: PRA24 |
![]() |
Regulatory Affairs: The Biologics License Application (BLA) for Marketing Approval in the USACourse ID: SUB15 |
![]() |
Regulatory Affairs: The 505(b)(2) Application for Marketing Approval in the USACourse ID: SUB16 |
Pharmaceutical Sales and Marketing
|
|
![]() |
Pharmaceutical Sales & Marketing: Legal and Regulatory Framework for Advertising and Promotion of Prescription Drugs in the USACourse ID: SAM01 |
![]() |
Pharmaceutical Sales & Marketing: Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USACourse ID: SAM02 |
![]() |
Pharmaceutical Sales & Marketing: Consumer-directed Advertising and Online Promotion of Prescription Drugs in the USACourse ID: SAM03 |
![]() |
Pharmaceutical Sales & Marketing: Marketing of Prescription Drugs in the USA- Interactions with Healthcare ProfessionalsCourse ID: SAM04 |
Validation for BioPharma Companies
|
|
![]() |
Validation: Introduction to ValidationCourse ID: VAL01 |
![]() |
Validation: Plans and DocumentationCourse ID: VAL02 |
![]() |
Validation: Commissioning and Installation Qualification (IQ)Course ID: VAL03 |
![]() |
Validation: Operational and Performance Qualification (OQ/PQ)Course ID: VAL04 |
![]() |
Validation: Equipment Cleaning ValidationCourse ID: VAL08 |



































































































































































