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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 TrainingFaculty 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.

CPD Accredited TrainingCME, 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:


Clinical Trials Management and Monitoring


Certification Training GCP: ICH-GCP Good Clinical Practice
Individual Course w/Certificate of Completion:

GCP: ICH-GCP Good Clinical Practice

Course ID: GCP001
Method of Training: Online, self-paced eLearning.
Length: 180 minutes
Price: $195.00


Certification Training Clinical Trials: Preparation and Design
Individual Course w/Certificate of Completion:

Clinical Trials: Preparation and Design

Course ID: GCP002
Method of Training: Online, self-paced eLearning.
Length: 240 minutes
Price: $225.00


Certification Training Clinical Trials and Drug Development
Individual Course w/Certificate of Completion:

Clinical Trials and Drug Development

Course ID: GCP003
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $175.00


Certification Training Clinical Trial Monitoring: Site Evaluation and Set-up
Individual Course w/Certificate of Completion:

Clinical Trial Monitoring: Site Evaluation and Set-up

Course ID: GCP004
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $175.00


Certification Training Clinical Trial Monitoring: Documentation and Closure
Individual Course w/Certificate of Completion:

Clinical Trial Monitoring: Documentation and Closure

Course ID: GCP005
Method of Training: Online, self-paced eLearning.
Length: 180 minutes
Price: $195.00


Certification Training Clinical Trials: Preparing for an Audit or Inspection
Individual Course w/Certificate of Completion:

Clinical Trials: Preparing for an Audit or Inspection

Course ID: GCP006
Method of Training: Online, self-paced eLearning.
Length: 150 minutes
Price: $225.00


Certification Training Clinical Trials: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials
Individual Course w/Certificate of Completion:

Clinical Trials: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials

Course ID: GCP007
Method of Training: Online, self-paced eLearning.
Length: 180 minutes
Price: $225.00


Certification Training Clinical Trials:  How to Obtain Approval to Conduct Clinical Trials in the EU
Individual Course w/Certificate of Completion:

Clinical Trials: How to Obtain Approval to Conduct Clinical Trials in the EU

Course ID: GCP020
Method of Training: Online, self-paced eLearning.
Length: 180 minutes
Price: $175.00


Certification Training Clinical Trials:  How to Gain Authorization for Clinical Research Under the EU Clinical Trials Regulation
Individual Course w/Certificate of Completion:

Clinical Trials: How to Gain Authorization for Clinical Research Under the EU Clinical Trials Regulation

Course ID: CT11
Method of Training: Online, self-paced eLearning.
Length: 120 minutes
Price: $225.00


Certification Training Clinical Trials: How to Conduct Clinical Research Under the EU Clinical Trials Regulation
Individual Course w/Certificate of Completion:

Clinical Trials: How to Conduct Clinical Research Under the EU Clinical Trials Regulation

Course ID: CT12
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $175.00



Computer System Validation (CSV)


Certification Training Validation: Computer System Validation (Part 1 of 2) (Planning)
Individual Course w/Certificate of Completion:

Validation: Computer System Validation (Part 1 of 2) (Planning)

Course ID: VAL09
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $195.00


Certification Training Validation: Computer System Validation (Part 2 of 2) (Implementation)
Individual Course w/Certificate of Completion:

Validation: Computer System Validation (Part 2 of 2) (Implementation)

Course ID: VAL10
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $195.00



Drug Safety


Certification Training Introduction to Drug Safety and Pharmacovigilance
Individual Course w/Certificate of Completion:

Introduction to Drug Safety and Pharmacovigilance

Course ID: AV02
Method of Training: Online, self-paced eLearning.
Length: 180 minutes
Price: $225.00


Certification Training Drug Safety: Signal Detection and Management in Pharmacovigilance
Individual Course w/Certificate of Completion:

Drug Safety: Signal Detection and Management in Pharmacovigilance

Course ID: PV04
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $195.00


Certification Training Drug Safety: Risk Management Planning for Medicinal Products
Individual Course w/Certificate of Completion:

Drug Safety: Risk Management Planning for Medicinal Products

Course ID: PV05
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $195.00


Certification Training Drug Safety: Urgent Safety Restrictions
Individual Course w/Certificate of Completion:

Drug Safety: Urgent Safety Restrictions

Course ID: PV06
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $195.00


Certification Training Drug Safety: Good Pharmacoepidemiology Practice
Individual Course w/Certificate of Completion:

Drug Safety: Good Pharmacoepidemiology Practice

Course ID: PV07
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $195.00


Certification Training Safety Reporting in Clinical Trials (Adverse Event Reporting)
Individual Course w/Certificate of Completion:

Safety Reporting in Clinical Trials (Adverse Event Reporting)

Course ID: CT13
Method of Training: Online, self-paced eLearning.
Length: 120 minutes
Price: $225.00


Certification Training Clinical Trial Safety Reporting Requirements in the EU and USA
Individual Course w/Certificate of Completion:

Clinical Trial Safety Reporting Requirements in the EU and USA

Course ID: CT14
Method of Training: Online, self-paced eLearning.
Length: 120 minutes
Price: $225.00


Certification Training Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration
Individual Course w/Certificate of Completion:

Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration

Course ID: PKPD01
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $189.00


Certification Training Conducting Pharmacokinetic and Pharmacodynamic Studies
Individual Course w/Certificate of Completion:

Conducting Pharmacokinetic and Pharmacodynamic Studies

Course ID: PKPD02
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $189.00



Electronic Records


Certification Training Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures)
Individual Course w/Certificate of Completion:

Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures)

Course ID: ESR01A
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $225.00



Good Manufacturing Practices


Certification Training cGMP:  Introduction to Good Manufacturing Practice for Medicinal Products
Individual Course w/Certificate of Completion:

cGMP: Introduction to Good Manufacturing Practice for Medicinal Products

Course ID: CGMP01
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $195.00


Certification Training cGMP: Good Documentation Practice (GDocP)
Individual Course w/Certificate of Completion:

cGMP: Good Documentation Practice (GDocP)

Course ID: CGMP02
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $195.00


Certification Training cGMP: Good Manufacturing Practice in Cleaning and Sanitation
Individual Course w/Certificate of Completion:

cGMP: Good Manufacturing Practice in Cleaning and Sanitation

Course ID: CGMP03
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $195.00


Certification Training cGMP: Good Manufacturing Practice for the Warehouse
Individual Course w/Certificate of Completion:

cGMP: Good Manufacturing Practice for the Warehouse

Course ID: CGMP04
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $195.00


Certification Training cGMP: Good Manufacturing Practice in Processing Medicinal Products
Individual Course w/Certificate of Completion:

cGMP: Good Manufacturing Practice in Processing Medicinal Products

Course ID: CGMP05
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $195.00


Certification Training cGMP: Good Manufacturing Practice in Packaging Medicinal Products
Individual Course w/Certificate of Completion:

cGMP: Good Manufacturing Practice in Packaging Medicinal Products

Course ID: CGMP06
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $195.00


Certification Training cGMP: Corrective and Preventive Action (CAPA) in Medicinal Product Manufacturing - Including Root Cause Analysis
Individual Course w/Certificate of Completion:

cGMP: Corrective and Preventive Action (CAPA) in Medicinal Product Manufacturing – Including Root Cause Analysis

Course ID: CGMP07
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $195.00



Medical Devices


Certification Training Introduction to the Regulation of Medical Devices
Individual Course w/Certificate of Completion:

Introduction to the Regulation of Medical Devices

Course ID: MDA0
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $195.00



Pharmaceutical Regulatory Affairs


Certification Training Regulatory Affairs: Essentials for Human Medicinal Products - EU and US
Individual Course w/Certificate of Completion:

Regulatory Affairs: Essentials for Human Medicinal Products – EU and US

Course ID: PRA01
Method of Training: Online, self-paced eLearning.
Length: 180 minutes
Price: $225.00


Certification Training Regulatory Affairs: Orphan Drug Application - EU and US
Individual Course w/Certificate of Completion:

Regulatory Affairs: Orphan Drug Application – EU and US

Course ID: PRA02
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $145.00


Certification Training Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format
Individual Course w/Certificate of Completion:

Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format

Course ID: PRA03
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $145.00


Certification Training Regulatory Affairs: Electronic Common Technical Document (eCTD)
Individual Course w/Certificate of Completion:

Regulatory Affairs: Electronic Common Technical Document (eCTD)

Course ID: PRA04
Method of Training: Online, self-paced eLearning.
Length: 150 minutes
Price: $225.00


Certification Training Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies
Individual Course w/Certificate of Completion:

Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies

Course ID: PRA05
Method of Training: Online, self-paced eLearning.
Length: 180 minutes
Price: $225.00


Certification Training Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US
Individual Course w/Certificate of Completion:

Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US

Course ID: PRA06
Method of Training: Online, self-paced eLearning.
Length: 180 minutes
Price: $225.00


Certification Training Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US
Individual Course w/Certificate of Completion:

Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US

Course ID: PRA07
Method of Training: Online, self-paced eLearning.
Length: 210 minutes
Price: $225.00


Certification Training Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA
Individual Course w/Certificate of Completion:

Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA

Course ID: PRA08
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $115.00


Certification Training Regulatory Affairs: The European Centralized Procedure (CP)
Individual Course w/Certificate of Completion:

Regulatory Affairs: The European Centralized Procedure (CP)

Course ID: PRA20
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $145.00


Certification Training Regulatory Affairs: The Mutual Recognition Procedure (MRP)
Individual Course w/Certificate of Completion:

Regulatory Affairs: The Mutual Recognition Procedure (MRP)

Course ID: PRA21
Method of Training: Online, self-paced eLearning.
Length: 120 minutes
Price: $195.00


Certification Training Regulatory Affairs: Variations to Marketing Authorizations in Europe
Individual Course w/Certificate of Completion:

Regulatory Affairs: Variations to Marketing Authorizations in Europe

Course ID: PRA22
Method of Training: Online, self-paced eLearning.
Length: 210 minutes
Price: $225.00


Certification Training Regulatory Affairs: The Decentralized Procedure (DCP)
Individual Course w/Certificate of Completion:

Regulatory Affairs: The Decentralized Procedure (DCP)

Course ID: PRA23
Method of Training: Online, self-paced eLearning.
Length: 120 minutes
Price: $195.00


Certification Training Regulatory Affairs: Essentials of Monoclonal Antibodies
Individual Course w/Certificate of Completion:

Regulatory Affairs: Essentials of Monoclonal Antibodies

Course ID: PRA24
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $145.00


Certification Training The Biologics License Application (BLA) for Marketing Approval in the USA
Individual Course w/Certificate of Completion:

The Biologics License Application (BLA) for Marketing Approval in the USA

Course ID: SUB15
Method of Training: Online, self-paced eLearning.
Length: 210 minutes
Price: $225.00


Certification Training The 505(b)(2) Application for Marketing Approval in the USA
Individual Course w/Certificate of Completion:

The 505(b)(2) Application for Marketing Approval in the USA

Course ID: SUB16
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $145.00



Pharmaceutical Sales and Marketing


Certification Training Pharmaceutical Sales & Marketing: Legal and Regulatory Framework for Advertising and Promotion of Prescription Drugs in the USA
Individual Course w/Certificate of Completion:

Pharmaceutical Sales & Marketing: Legal and Regulatory Framework for Advertising and Promotion of Prescription Drugs in the USA

Course ID: SAM01
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $185.00


Certification Training Pharmaceutical Sales & Marketing: Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USA
Individual Course w/Certificate of Completion:

Pharmaceutical Sales & Marketing: Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USA

Course ID: SAM02
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $185.00


Certification Training Pharmaceutical Sales & Marketing: Consumer-directed Advertising and Online Promotion of Prescription Drugs in the USA
Individual Course w/Certificate of Completion:

Pharmaceutical Sales & Marketing: Consumer-directed Advertising and Online Promotion of Prescription Drugs in the USA

Course ID: SAM03
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $185.00


Certification Training Pharmaceutical Sales & Marketing: Marketing of Prescription Drugs in the USA- Interactions with Healthcare Professionals
Individual Course w/Certificate of Completion:

Pharmaceutical Sales & Marketing: Marketing of Prescription Drugs in the USA- Interactions with Healthcare Professionals

Course ID: SAM04
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $185.00



Validation for BioPharma Companies


Certification Training Validation: Introduction to Validation
Individual Course w/Certificate of Completion:

Validation: Introduction to Validation

Course ID: VAL01
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $195.00


Certification Training Validation: Plans and Documentation
Individual Course w/Certificate of Completion:

Validation: Plans and Documentation

Course ID: VAL02
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $195.00


Certification Training Validation: Commissioning and Installation Qualification (IQ)
Individual Course w/Certificate of Completion:

Validation: Commissioning and Installation Qualification (IQ)

Course ID: VAL03
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $195.00


Certification Training Validation: Operational and Performance Qualification (OQ/PQ)
Individual Course w/Certificate of Completion:

Validation: Operational and Performance Qualification (OQ/PQ)

Course ID: VAL04
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $195.00


Certification Training Validation: Equipment Cleaning Validation
Individual Course w/Certificate of Completion:

Validation: Equipment Cleaning Validation

Course ID: VAL08
Method of Training: Online, self-paced eLearning.
Length: 90 minutes
Price: $195.00


Online Training Benefits:

Immediate access to courses: Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning: 24/7 access to all course materials and assessments for 12 months.
Open enrollment: No prior course prerequisites or work experience required.
Expertise: Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated: Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning: Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access: Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments: Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates: Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training: Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access: A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses: Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs): POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement: Some employers may reimburse their employees for training expenses. Check your company’s policy.
Financial assistance: Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement: Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.