Internationally Accredited Training Courses
Many of Biopharma Institute’s clinical research, regulatory affairs, cGMP, validation, and drug safety courses are internationally accredited by the CPD Accredited Training Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom.
These programs not only deliver world-class training but also award learners with Continuing Professional Development (CPD) points, a mark of recognized professional achievement.
Upon successful completion of each course—including passing the multiple-choice assessment—learners earn CPD points proportional to the course duration. These points are proudly displayed on the official certificate of completion, providing participants with tangible proof of their continuing education and commitment to excellence.
Global Recognition and Transferability
In addition to CPD points, most credentialing centers in the U.S. and internationally will accept CPD credits toward other recognized units, such as:
- CME credits for medical doctors
- CEU credits for nurses
- CPE credits for pharmacists
Because guidelines may vary across licensing boards, we recommend confirming transfer requirements with your local authority before enrolling.
By choosing Biopharma Institute, you’re not only advancing your knowledge and compliance expertise—you’re also earning internationally recognized credentials that strengthen your career and professional standing.
Accredited Training Programs Offering CPD Credits:
- Clinical Trials Management and Monitoring
- Computer System Validation (CSV)
- Data Integrity & Electronic Signatures / Records
- Drug Safety
- Good Laboratory Practices
- Good Manufacturing Practices
- Medical Devices
- Pharmaceutical Regulatory Affairs
- Pharmaceutical Sales and Marketing
- Validation for GxP Compliant Companies
Clinical Trials Management and Monitoring
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GCP: ICH-GCP Good Clinical Practice E6(R3)Course 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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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 |
Computer System Validation (CSV)
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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 |
Drug Safety
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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 |
Electronic Records
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Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures)Course ID: ESR01A |
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Assuring Data Integrity in the Manufacture of Medicinal ProductsCourse ID: ICT02 |
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Assuring Data Integrity in Clinical ResearchCourse ID: ICT03 |
Good Laboratory Practices
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Good Laboratory Practice (GLP)Course ID: GLP01 |
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G(QC)LP: Good Quality Control Laboratory PracticeCourse ID: GLP02 |
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Good Clinical Laboratory Practice (GCLP)Course ID: GLP03 |
Good Manufacturing Practices
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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 |
Medical Devices
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Introduction to the Regulation of Medical DevicesCourse ID: MDA0 |
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Quality Management System Requirements for Medical Devices under ISO 13485:2016 and FDA QMSRCourse ID: MD02 |
Pharmaceutical Regulatory Affairs
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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 USACourse ID: PRA06 |
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Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the USACourse 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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Regulatory Affairs: The Biologics License Application (BLA) for Marketing Approval in the USACourse ID: SUB15 |
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Regulatory Affairs: The 505(b)(2) Application for Marketing Approval in the USACourse ID: SUB16 |
Pharmaceutical Sales and Marketing
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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 |
Validation for BioPharma Companies
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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 |
Benefits of Training with Biopharma Institute:
| Immediate Course Access: | Login details, instructions, and payment confirmation are emailed immediately upon online enrollment. |
| Self-Paced eLearning: | Enjoy 24/7 access to all course materials and assessments for 12 months. |
| Open Enrollment: | No prerequisites or prior work experience required to start. |
| Expert-Developed Content: | Courses are designed by subject matter experts (SMEs) in their respective fields. |
| Up-to-Date & Validated: | Training is regularly updated to meet current regulations and is third-party validated or accredited. |
| Optimized for Learning: | Courses feature voiceovers, intuitive navigation, reading materials, case studies, progress checks, and animations to boost knowledge retention. |
| Secure Access: | Encrypted connections, firewalls, and daily malware scans ensure security and system performance. |
| Flexible Assessments: | Multiple-choice exams can be retaken until a passing score is achieved. |
| Instant Certificates: | Certificates are issued instantly in secure PDF format with watermark, unique validation code, and QR code for verification. |
| Training Verification: | Certificates can be verified online using a QR code or unique ID. Digital badges are included with professional certifications. |
| Manager Access: | A secure portal allows managers to view and download enrollment reports, training records, account balances, and more. |
| SCORM-Compliant: | Courses can be integrated directly into most corporate Learning Management Systems (LMS). |
| Purchase Orders: | We accept POs from all companies. Request an invoice to start the procurement process. |
| Employer Reimbursement: | Some employers may cover training costs -check your company’s reimbursement policy. |
| Financial Assistance: | Payment plans are available for eligible learners, or purchase courses individually as needed. |
| Career Advancement: | Professional certifications highlight dedication to career growth, enhance resumes, provide interview talking points, and equip learners with practical job skills. |


































































