Student Login |


Wednesday, October 04, 2023
Home » About Us » Accredited Courses

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:


Change Control


Certification Training Change Control - Regulations & Guidelines
Individual Course w/Certificate of Completion:

Change Control – Regulations & Guidelines

Course ID: ELM-159
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training Change Control & Change Management
Individual Course w/Certificate of Completion:

Change Control & Change Management

Course ID: ELM-160
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training The Lifecycle of a Change Control Program - Phase 1: Develop the Change Request
Individual Course w/Certificate of Completion:

The Lifecycle of a Change Control Program – Phase 1: Develop the Change Request

Course ID: ELM-161
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training The Lifecycle of a Change Control Program - Phase 2: Evaluate
Individual Course w/Certificate of Completion:

The Lifecycle of a Change Control Program – Phase 2: Evaluate

Course ID: ELM-178
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training The Lifecycle of a Change Control Program - Phase 3: Implement Phase 4: Review
Individual Course w/Certificate of Completion:

The Lifecycle of a Change Control Program – Phase 3: Implement Phase 4: Review

Course ID: ELM-179
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Examples of Change Controls, Documents & Recording Completed Changes
Individual Course w/Certificate of Completion:

Examples of Change Controls, Documents & Recording Completed Changes

Course ID: ELM-180
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00



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 ICH E6(R2) - Clinical Trial Protocol and Protocol Amendment (Chapter 6)
Individual Course w/Certificate of Completion:

ICH E6(R2) – Clinical Trial Protocol and Protocol Amendment (Chapter 6)

Course ID: ELM-915
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training ICH E6(R2) - Introduction and Principles of Good Clinical Practices (GCP) (Chapter 1-2)
Individual Course w/Certificate of Completion:

ICH E6(R2) – Introduction and Principles of Good Clinical Practices (GCP) (Chapter 1-2)

Course ID: ELM-904
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training ICH E6(R2) - Institutional Review Board / Independent Ethics Committee (IRB/IEC) (Chapter 3)
Individual Course w/Certificate of Completion:

ICH E6(R2) – Institutional Review Board / Independent Ethics Committee (IRB/IEC) (Chapter 3)

Course ID: ELM-924
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


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


Certification Training Clinical Trials: 21 CFR Part 50 Subpart B - Informed Consent of Human Subjects (HSP) [Part 1 of 2]
Individual Course w/Certificate of Completion:

Clinical Trials: 21 CFR Part 50 Subpart B – Informed Consent of Human Subjects (HSP) [Part 1 of 2]

Course ID: ELM-909
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Clinical Trials: 21 CFR Part 50 Subpart B - Informed Consent of Human Subjects (HSP) [Part 2 of 2]
Individual Course w/Certificate of Completion:

Clinical Trials: 21 CFR Part 50 Subpart B – Informed Consent of Human Subjects (HSP) [Part 2 of 2]

Course ID: ELM-910
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GCP: An Introduction to Good Clinical Practices - Part 1 of 3
Individual Course w/Certificate of Completion:

GCP: An Introduction to Good Clinical Practices – Part 1 of 3

Course ID: ELM-901
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GCP: An Introduction to Good Clinical Practices - Part 2 of 3
Individual Course w/Certificate of Completion:

GCP: An Introduction to Good Clinical Practices – Part 2 of 3

Course ID: ELM-902
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GCP: An Introduction to Good Clinical Practices - Part 3 of 3
Individual Course w/Certificate of Completion:

GCP: An Introduction to Good Clinical Practices – Part 3 of 3

Course ID: ELM-903
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00



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


Certification Training Validation: Introduction to Software Validation (Part 1 of 2)
Individual Course w/Certificate of Completion:

Validation: Introduction to Software Validation (Part 1 of 2)

Course ID: ELM-113
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training Validation: Introduction to Software Validation (Part 2 of 2)
Individual Course w/Certificate of Completion:

Validation: Introduction to Software Validation (Part 2 of 2)

Course ID: ELM-119
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training Validation: The Life Cycle of a Software Validation Protocol
Individual Course w/Certificate of Completion:

Validation: The Life Cycle of a Software Validation Protocol

Course ID: ELM-111
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training Validation: Implementing Compliant Systems in the Cloud
Individual Course w/Certificate of Completion:

Validation: Implementing Compliant Systems in the Cloud

Course ID: ELM-118
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training Validation: Managing and Ensuring Data Integrity of E-Records within a Regulated Environment
Individual Course w/Certificate of Completion:

Validation: Managing and Ensuring Data Integrity of E-Records within a Regulated Environment

Course ID: ELM-125
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training CSV: Computer System Validation - Basic Concepts & GAMP®5
Individual Course w/Certificate of Completion:

CSV: Computer System Validation – Basic Concepts & GAMP®5

Course ID: ELM-132
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training CSV: Computer System Validation - The Regulated Software Life Cycle
Individual Course w/Certificate of Completion:

CSV: Computer System Validation – The Regulated Software Life Cycle

Course ID: ELM-133
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training CSV: Computer System Validation - Requirements: The Basis for Validation
Individual Course w/Certificate of Completion:

CSV: Computer System Validation – Requirements: The Basis for Validation

Course ID: ELM-134
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training CSV: Computer System Validation - Risk Management
Individual Course w/Certificate of Completion:

CSV: Computer System Validation – Risk Management

Course ID: ELM-162
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training CSV: Computer System Validation - The Master Validation Plan (MVP)
Individual Course w/Certificate of Completion:

CSV: Computer System Validation – The Master Validation Plan (MVP)

Course ID: ELM-163
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training CSV: Application of the Validation Plan
Individual Course w/Certificate of Completion:

CSV: Application of the Validation Plan

Course ID: ELM-164
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training CSV: Validation Testing - Part 1
Individual Course w/Certificate of Completion:

CSV: Validation Testing – Part 1

Course ID: ELM-165A
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training CSV: Validation Testing - Part 2
Individual Course w/Certificate of Completion:

CSV: Validation Testing – Part 2

Course ID: ELM-165B
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training CSV: Maintaining the Validated State
Individual Course w/Certificate of Completion:

CSV: Maintaining the Validated State

Course ID: ELM-166A
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training CSV: Supplier Provided Software
Individual Course w/Certificate of Completion:

CSV: Supplier Provided Software

Course ID: ELM-166B
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training CSV: Special Topics
Individual Course w/Certificate of Completion:

CSV: Special Topics

Course ID: ELM-167
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training CSV: Periodic Review Strategies - Part 1
Individual Course w/Certificate of Completion:

CSV: Periodic Review Strategies – Part 1

Course ID: ELM-149A
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training CSV: Periodic Review Strategies - Part 2
Individual Course w/Certificate of Completion:

CSV: Periodic Review Strategies – Part 2

Course ID: ELM-149B
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00



Contamination Control


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

Introduction to Cleaning Validation

Course ID: ELM-601
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training Types of Contamination in a GMP Environment
Individual Course w/Certificate of Completion:

Types of Contamination in a GMP Environment

Course ID: ELM-701
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training Sources of Contamination in a GMP Environment
Individual Course w/Certificate of Completion:

Sources of Contamination in a GMP Environment

Course ID: ELM-702
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training Contamination Prevention and Control - Quality Risk Management (QRM)
Individual Course w/Certificate of Completion:

Contamination Prevention and Control – Quality Risk Management (QRM)

Course ID: ELM-703
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training Contamination Control Strategies in a GMP Environment
Individual Course w/Certificate of Completion:

Contamination Control Strategies in a GMP Environment

Course ID: ELM-704
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training The Basic Principles of Isolator Technology
Individual Course w/Certificate of Completion:

The Basic Principles of Isolator Technology

Course ID: ELM-707
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Restricted Access Barrier Systems (RABS) Glove Training
Individual Course w/Certificate of Completion:

Restricted Access Barrier Systems (RABS) Glove Training

Course ID: ELM-708
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


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

Introduction to Endotoxin Control

Course ID: ELM-709
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training How Deviations (Non-Conformance) Should be Handled from a Regulatory Perspective
Individual Course w/Certificate of Completion:

How Deviations (Non-Conformance) Should be Handled from a Regulatory Perspective

Course ID: ELM-712
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training Pharmaceutical Contamination and Microorganisms
Individual Course w/Certificate of Completion:

Pharmaceutical Contamination and Microorganisms

Course ID: ELM-713
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training Sources of Pharmaceutical Contamination
Individual Course w/Certificate of Completion:

Sources of Pharmaceutical Contamination

Course ID: ELM-714
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training The Use of Vaporized Hydrogen Peroxide (VHP) Chambers
Individual Course w/Certificate of Completion:

The Use of Vaporized Hydrogen Peroxide (VHP) Chambers

Course ID: ELM-715
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training Contamination Control Strategies in a GMP Environment: Cleaning and Disinfection
Individual Course w/Certificate of Completion:

Contamination Control Strategies in a GMP Environment: Cleaning and Disinfection

Course ID: ELM-716
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training GMP Contamination Control Strategies - Personnel
Individual Course w/Certificate of Completion:

GMP Contamination Control Strategies – Personnel

Course ID: ELM-717
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training GMP Contamination Control Strategies - Buildings and Facilities
Individual Course w/Certificate of Completion:

GMP Contamination Control Strategies – Buildings and Facilities

Course ID: ELM-718
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00



Data Integrity


Certification Training Data Integrity: An Introduction to Data Integrity
Individual Course w/Certificate of Completion:

Data Integrity: An Introduction to Data Integrity

Course ID: ELM-148
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Data Integrity: Health Authority Expectations
Individual Course w/Certificate of Completion:

Data Integrity: Health Authority Expectations

Course ID: ELM-151
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Data Integrity: ALCOA and ALCOA+
Individual Course w/Certificate of Completion:

Data Integrity: ALCOA and ALCOA+

Course ID: ELM-152
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


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

Data Integrity: Good Documentation Practice (GDocP)

Course ID: ELM-153
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Data Integrity: Computer System Validation (CSV) Best Practices
Individual Course w/Certificate of Completion:

Data Integrity: Computer System Validation (CSV) Best Practices

Course ID: ELM-154
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Data Integrity: Data Governance
Individual Course w/Certificate of Completion:

Data Integrity: Data Governance

Course ID: ELM-155
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00



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


Certification Training Good Pharmacovigilance Practices (GVP): An Introduction to Pharmacovigilance and Adverse Drug Reaction
Individual Course w/Certificate of Completion:

Good Pharmacovigilance Practices (GVP): An Introduction to Pharmacovigilance and Adverse Drug Reaction

Course ID: ELM-920
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training Good Pharmacovigilance Practices (GVP): Legal Framework of the Global Pharmacovigilance Program
Individual Course w/Certificate of Completion:

Good Pharmacovigilance Practices (GVP): Legal Framework of the Global Pharmacovigilance Program

Course ID: ELM-921
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training Good Pharmacovigilance Practices (GVP): Updates to the European Union GVP Guidelines
Individual Course w/Certificate of Completion:

Good Pharmacovigilance Practices (GVP): Updates to the European Union GVP Guidelines

Course ID: ELM-922
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training Good Pharmacovigilance Practices (GVP): Recent Inspections and Warning Letter Case Studies
Individual Course w/Certificate of Completion:

Good Pharmacovigilance Practices (GVP): Recent Inspections and Warning Letter Case Studies

Course ID: ELM-923
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00



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


Certification Training 21 CFR Part 11 - An Introduction
Individual Course w/Certificate of Completion:

21 CFR Part 11 – An Introduction

Course ID: ELM-112
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training 21 CFR Part 11 - Electronic Records
Individual Course w/Certificate of Completion:

21 CFR Part 11 – Electronic Records

Course ID: ELM-114
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training 21 CFR Part 11 - Electronic Signatures
Individual Course w/Certificate of Completion:

21 CFR Part 11 – Electronic Signatures

Course ID: ELM-115
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training 21 CFR Part 11 - 2003 Guidance
Individual Course w/Certificate of Completion:

21 CFR Part 11 – 2003 Guidance

Course ID: ELM-116
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00



Good Distribution Practices


Certification Training Good Distribution Practices in Pharma (GDP) - Part 1
Individual Course w/Certificate of Completion:

Good Distribution Practices in Pharma (GDP) – Part 1

Course ID: ELM-234
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training Good Distribution Practices in Pharma (GDP) - Part 2
Individual Course w/Certificate of Completion:

Good Distribution Practices in Pharma (GDP) – Part 2

Course ID: ELM-235
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training Good Distribution Practices in Pharma (GDP) - Part 3
Individual Course w/Certificate of Completion:

Good Distribution Practices in Pharma (GDP) – Part 3

Course ID: ELM-240
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00



Good Documentation Practices


Certification Training GDocP: Good Documentation Practices and Data Integrity
Individual Course w/Certificate of Completion:

GDocP: Good Documentation Practices and Data Integrity

Course ID: ELM-104
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training GDocP: Corrective Actions and Preventive Actions (CAPA) - Including Root Cause Analysis
Individual Course w/Certificate of Completion:

GDocP: Corrective Actions and Preventive Actions (CAPA) – Including Root Cause Analysis

Course ID: ELM-117
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training GDocP: How to Write Effective Standard Operating Procedures (SOPs)
Individual Course w/Certificate of Completion:

GDocP: How to Write Effective Standard Operating Procedures (SOPs)

Course ID: ELM-126
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training GDocP: How to Write an Effective Equipment User Requirement Specification (URS)
Individual Course w/Certificate of Completion:

GDocP: How to Write an Effective Equipment User Requirement Specification (URS)

Course ID: ELM-127
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training GDocP: How to Manage Deviations in a GMP Environment - Part 1 of 2
Individual Course w/Certificate of Completion:

GDocP: How to Manage Deviations in a GMP Environment – Part 1 of 2

Course ID: ELM-130
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GDocP: How to Manage Deviations in a GMP Environment - Part 2 of 2
Individual Course w/Certificate of Completion:

GDocP: How to Manage Deviations in a GMP Environment – Part 2 of 2

Course ID: ELM-131
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GDocP: Good Documentation Practices - General Rules of Data Integrity
Individual Course w/Certificate of Completion:

GDocP: Good Documentation Practices – General Rules of Data Integrity

Course ID: ELM-501
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training GDocP: Good Documentation Practices - Making Correction to Ensure Data Integrity
Individual Course w/Certificate of Completion:

GDocP: Good Documentation Practices – Making Correction to Ensure Data Integrity

Course ID: ELM-502
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training GDocP: Good Documentation Practices - Logbook Data Integrity
Individual Course w/Certificate of Completion:

GDocP: Good Documentation Practices – Logbook Data Integrity

Course ID: ELM-503
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training GDocP: Good Documentation Practices - Data Integrity for General Test Results
Individual Course w/Certificate of Completion:

GDocP: Good Documentation Practices – Data Integrity for General Test Results

Course ID: ELM-504
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00



Good Laboratory Practices


Certification Training GLP: An Introduction to Good Laboratory Practices (GLP)
Individual Course w/Certificate of Completion:

GLP: An Introduction to Good Laboratory Practices (GLP)

Course ID: ELM-101
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training GLP: Laboratory Data Integrity and the Principles of ALCOA (GDocP)
Individual Course w/Certificate of Completion:

GLP: Laboratory Data Integrity and the Principles of ALCOA (GDocP)

Course ID: ELM-102
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training GLP: How to Prepare for Internal & External Laboratory Audits
Individual Course w/Certificate of Completion:

GLP: How to Prepare for Internal & External Laboratory Audits

Course ID: ELM-106
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training GLP: Laboratory Investigations & Deviations
Individual Course w/Certificate of Completion:

GLP: Laboratory Investigations & Deviations

Course ID: ELM-108
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training GLP: Performing Analytical Analysis in a Regulated Laboratory
Individual Course w/Certificate of Completion:

GLP: Performing Analytical Analysis in a Regulated Laboratory

Course ID: ELM-109
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training GLP: Organization, Roles and Infrastructure for Regulated or Accredited Laboratories
Individual Course w/Certificate of Completion:

GLP: Organization, Roles and Infrastructure for Regulated or Accredited Laboratories

Course ID: ELM-110
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training GLP: The Basics of Laboratory Investigations
Individual Course w/Certificate of Completion:

GLP: The Basics of Laboratory Investigations

Course ID: ELM-174
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GLP: How to Conduct a Laboratory Investigation
Individual Course w/Certificate of Completion:

GLP: How to Conduct a Laboratory Investigation

Course ID: ELM-175
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00



Good Manufacturing Practices


Certification Training GxP: Good Practices (GxP) in Drug Development and Manufacturing
Individual Course w/Certificate of Completion:

GxP: Good Practices (GxP) in Drug Development and Manufacturing

Course ID: GXP01
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $195.00


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


Certification Training GMP: Introduction to Good Manufacturing Practices (For Beginners)
Individual Course w/Certificate of Completion:

GMP: Introduction to Good Manufacturing Practices (For Beginners)

Course ID: ELM-722
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: The Devastating Effects of Not Following cGMP (For Beginners)
Individual Course w/Certificate of Completion:

GMP: The Devastating Effects of Not Following cGMP (For Beginners)

Course ID: ELM-710
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training GMP: Good Manufacturing Practices
Individual Course w/Certificate of Completion:

GMP: Good Manufacturing Practices

Course ID: ELM-103
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training GMP: Cases from History and the Regulations
Individual Course w/Certificate of Completion:

GMP: Cases from History and the Regulations

Course ID: ELM-201
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training GMP: Good Manufacturing Practices - QMS, Premises and Personnel
Individual Course w/Certificate of Completion:

GMP: Good Manufacturing Practices – QMS, Premises and Personnel

Course ID: ELM-202
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training GMP: Equipment, Validation, Complaints and Self Inspection
Individual Course w/Certificate of Completion:

GMP: Equipment, Validation, Complaints and Self Inspection

Course ID: ELM-203
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training GMP: Good Manufacturing Practices - Good Practices and Quality Control
Individual Course w/Certificate of Completion:

GMP: Good Manufacturing Practices – Good Practices and Quality Control

Course ID: ELM-204
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 211 Subpart B - Organization and Personnel
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 211 Subpart B – Organization and Personnel

Course ID: ELM-211
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 211 Subpart C - Building and Facilities
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 211 Subpart C – Building and Facilities

Course ID: ELM-205
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 211 Subpart D - Equipment
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 211 Subpart D – Equipment

Course ID: ELM-212
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 211 Subpart E - Control of Components, Drug Product Containers and Closures
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 211 Subpart E – Control of Components, Drug Product Containers and Closures

Course ID: ELM-206
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 211 Subpart F - Production and Process Controls
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 211 Subpart F – Production and Process Controls

Course ID: ELM-208
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 211 Subpart G - Packaging and Labeling Control
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 211 Subpart G – Packaging and Labeling Control

Course ID: ELM-209
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 211 Subpart H - Holding and Distribution
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 211 Subpart H – Holding and Distribution

Course ID: ELM-207
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 211 Subpart J - Records and Reports
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 211 Subpart J – Records and Reports

Course ID: ELM-210
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 211 Subpart K - Returned and Salvaged Drug Products
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 211 Subpart K – Returned and Salvaged Drug Products

Course ID: ELM-213
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: Behavioral Based Quality (BBQ) for a GMP Environment
Individual Course w/Certificate of Completion:

GMP: Behavioral Based Quality (BBQ) for a GMP Environment

Course ID: ELM-120
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training GMP: Combination Products (Drugs, Devices and Biologics) - Part 1 of 3
Individual Course w/Certificate of Completion:

GMP: Combination Products (Drugs, Devices and Biologics) – Part 1 of 3

Course ID: ELM-145
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: Combination Products (Drugs, Devices and Biologics) - Part 2 of 3
Individual Course w/Certificate of Completion:

GMP: Combination Products (Drugs, Devices and Biologics) – Part 2 of 3

Course ID: ELM-146
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: Combination Products (Drugs, Devices and Biologics) - Part 3 of 3
Individual Course w/Certificate of Completion:

GMP: Combination Products (Drugs, Devices and Biologics) – Part 3 of 3

Course ID: ELM-147
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: FDA Inspection Readiness- How to be an Effective GMP Auditor (Part 1 of 3)
Individual Course w/Certificate of Completion:

GMP: FDA Inspection Readiness- How to be an Effective GMP Auditor (Part 1 of 3)

Course ID: ELM-122
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: FDA Inspection Readiness- How to be an Effective GMP Auditor (Part 2 of 3)
Individual Course w/Certificate of Completion:

GMP: FDA Inspection Readiness- How to be an Effective GMP Auditor (Part 2 of 3)

Course ID: ELM-123
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: FDA Inspection Readiness- How to be an Effective GMP Auditor (Part 3 of 3)
Individual Course w/Certificate of Completion:

GMP: FDA Inspection Readiness- How to be an Effective GMP Auditor (Part 3 of 3)

Course ID: ELM-124
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training General GMP Inspection Readiness
Individual Course w/Certificate of Completion:

General GMP Inspection Readiness

Course ID: ELM-190
Method of Training: Online, self-paced eLearning.
Length: 25 minutes
Price: $199.00


Certification Training GMP Inspection Readiness: Your Role & Preparing for Inspector Interactions
Individual Course w/Certificate of Completion:

GMP Inspection Readiness: Your Role & Preparing for Inspector Interactions

Course ID: ELM-191
Method of Training: Online, self-paced eLearning.
Length: 25 minutes
Price: $199.00


Certification Training GMP: China Food and Drug Administration (CFDA) - GMP for Medical Devices
Individual Course w/Certificate of Completion:

GMP: China Food and Drug Administration (CFDA) – GMP for Medical Devices

Course ID: ELM-330
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training GMP: China Food and Drug Administration (CFDA) - GMP for Implantable Medical Devices
Individual Course w/Certificate of Completion:

GMP: China Food and Drug Administration (CFDA) – GMP for Implantable Medical Devices

Course ID: ELM-331
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training Quality Risk Management (QRM) - An Introduction to ICH Q9 - Part 1
Individual Course w/Certificate of Completion:

Quality Risk Management (QRM) – An Introduction to ICH Q9 – Part 1

Course ID: ELM-232a
Method of Training: Online, self-paced eLearning.
Length: 25 minutes
Price: $199.00


Certification Training Quality Risk Management (QRM) - How QRM Applies to You and Regulations Review - Part 2
Individual Course w/Certificate of Completion:

Quality Risk Management (QRM) – How QRM Applies to You and Regulations Review – Part 2

Course ID: ELM-232b
Method of Training: Online, self-paced eLearning.
Length: 25 minutes
Price: $199.00



Medical Devices


Certification Training MDSAP: Country Specific Requirements for Brazil
Individual Course w/Certificate of Completion:

MDSAP: Country Specific Requirements for Brazil

Course ID: ELM-141
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training MDSAP: Country Specific Requirements for Japan
Individual Course w/Certificate of Completion:

MDSAP: Country Specific Requirements for Japan

Course ID: ELM-144
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


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


Certification Training ISO 14971:2019 - The Scope of the Standard
Individual Course w/Certificate of Completion:

ISO 14971:2019 – The Scope of the Standard

Course ID: ELM-333
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training ISO 14971:2019 - The Evolution and Definitions
Individual Course w/Certificate of Completion:

ISO 14971:2019 – The Evolution and Definitions

Course ID: ELM-334
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training ISO 14971: Basic Framework for Risk Management
Individual Course w/Certificate of Completion:

ISO 14971: Basic Framework for Risk Management

Course ID: ELM-335
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training ISO 14971: Characterizing the Device & Identifying Hazards
Individual Course w/Certificate of Completion:

ISO 14971: Characterizing the Device & Identifying Hazards

Course ID: ELM-336
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training ISO 14971: Risk Analysis, Evaluation & Control
Individual Course w/Certificate of Completion:

ISO 14971: Risk Analysis, Evaluation & Control

Course ID: ELM-337
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training ISO 14971: Different Perspectives of a Risk Management Program
Individual Course w/Certificate of Completion:

ISO 14971: Different Perspectives of a Risk Management Program

Course ID: ELM-338
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training ISO 13485:2016 - Chapter 1-3: Introduction
Individual Course w/Certificate of Completion:

ISO 13485:2016 – Chapter 1-3: Introduction

Course ID: ELM-801
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training ISO 13485:2016 - Chapter 4: The Quality Management System (QMS)
Individual Course w/Certificate of Completion:

ISO 13485:2016 – Chapter 4: The Quality Management System (QMS)

Course ID: ELM-802
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training ISO 13485:2016 - Chapter 5: Management Responsibility
Individual Course w/Certificate of Completion:

ISO 13485:2016 – Chapter 5: Management Responsibility

Course ID: ELM-803
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training ISO 13485:2016 - Chapter 6: Resource Management
Individual Course w/Certificate of Completion:

ISO 13485:2016 – Chapter 6: Resource Management

Course ID: ELM-804
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training ISO 13485:2016 - Product Realization (Chapter 7 - Part A)
Individual Course w/Certificate of Completion:

ISO 13485:2016 – Product Realization (Chapter 7 – Part A)

Course ID: ELM-805
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training ISO 13485:2016 - Product Realization (Chapter 7 - Part B)
Individual Course w/Certificate of Completion:

ISO 13485:2016 – Product Realization (Chapter 7 – Part B)

Course ID: ELM-806
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training ISO 13485:2016 - Measurement Analysis and Improvement (Chapter 8 - Part A)
Individual Course w/Certificate of Completion:

ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part A)

Course ID: ELM-807
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training ISO 13485:2016 - Measurement Analysis and Improvement (Chapter 8 - Part B)
Individual Course w/Certificate of Completion:

ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part B)

Course ID: ELM-808
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 820 Subpart A - General Provisions
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart A – General Provisions

Course ID: ELM-301
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 820 Subpart B - Quality System Requirements (QSR)
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart B – Quality System Requirements (QSR)

Course ID: ELM-302
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 820 Subpart C - Design Controls
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart C – Design Controls

Course ID: ELM-303
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 820 Subpart D - Document Controls
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart D – Document Controls

Course ID: ELM-304
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 820 Subpart E - Purchasing Controls
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart E – Purchasing Controls

Course ID: ELM-305
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 820 Subpart F - Identification and Traceability
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart F – Identification and Traceability

Course ID: ELM-306
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 820 Subpart G - Production and Process Controls
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart G – Production and Process Controls

Course ID: ELM-307
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 820 Subpart H - Acceptance Activities
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart H – Acceptance Activities

Course ID: ELM-308
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 820 Subpart I - Nonconforming Products
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart I – Nonconforming Products

Course ID: ELM-309
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 820 Subpart J - Corrective and Preventive Action
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart J – Corrective and Preventive Action

Course ID: ELM-310
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 820 Subpart K - Labeling and Packaging Control
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart K – Labeling and Packaging Control

Course ID: ELM-311
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 820 Subpart L - Handling, Storage, Distribution and Installation
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart L – Handling, Storage, Distribution and Installation

Course ID: ELM-312
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 820 Subpart M - Records
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart M – Records

Course ID: ELM-313
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 820 Subpart N - Servicing
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart N – Servicing

Course ID: ELM-314
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training GMP: 21 CFR Part 820 Subpart O - Statistical Techniques
Individual Course w/Certificate of Completion:

GMP: 21 CFR Part 820 Subpart O – Statistical Techniques

Course ID: ELM-315
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training EU MDR: EU Medical Device Regulation - Introduction
Individual Course w/Certificate of Completion:

EU MDR: EU Medical Device Regulation – Introduction

Course ID: ELM-316
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training EU MDR: EU Medical Device Regulation - Chapters 1 to 5
Individual Course w/Certificate of Completion:

EU MDR: EU Medical Device Regulation – Chapters 1 to 5

Course ID: ELM-327
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training EU MDR: EU Medical Device Regulation - Chapter 1: Scope and Definitions
Individual Course w/Certificate of Completion:

EU MDR: EU Medical Device Regulation – Chapter 1: Scope and Definitions

Course ID: ELM-317
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training EU MDR: EU Medical Device Regulation - Chapter 2: Making Available on the Market
Individual Course w/Certificate of Completion:

EU MDR: EU Medical Device Regulation – Chapter 2: Making Available on the Market

Course ID: ELM-318
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training EU MDR: EU Medical Device Regulation - Chapter 3: Identification, Traceability and Registration of Devices
Individual Course w/Certificate of Completion:

EU MDR: EU Medical Device Regulation – Chapter 3: Identification, Traceability and Registration of Devices

Course ID: ELM-319
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training EU MDR: EU Medical Device Regulation - Chapter 4: Notified Bodies
Individual Course w/Certificate of Completion:

EU MDR: EU Medical Device Regulation – Chapter 4: Notified Bodies

Course ID: ELM-320
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training EU MDR: EU Medical Device Regulation - Chapter 5: Classification and Conformity
Individual Course w/Certificate of Completion:

EU MDR: EU Medical Device Regulation – Chapter 5: Classification and Conformity

Course ID: ELM-321
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training EU MDR: EU Medical Device Regulation - Chapters 6 to 10
Individual Course w/Certificate of Completion:

EU MDR: EU Medical Device Regulation – Chapters 6 to 10

Course ID: ELM-328
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training EU MDR: EU Medical Device Regulation - Chapter 6: Clinical Evaluation and Clinical Investigations
Individual Course w/Certificate of Completion:

EU MDR: EU Medical Device Regulation – Chapter 6: Clinical Evaluation and Clinical Investigations

Course ID: ELM-322
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training EU MDR: EU Medical Device Regulation - Chapter 7: Post Market Surveillance, Vigilance and Market Surveillance
Individual Course w/Certificate of Completion:

EU MDR: EU Medical Device Regulation – Chapter 7: Post Market Surveillance, Vigilance and Market Surveillance

Course ID: ELM-323
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training EU MDR: EU Medical Device Regulation - Chapter 8: Cooperation Between Member States, Medical Device Coordination Group, Expert Laboratories, etc.
Individual Course w/Certificate of Completion:

EU MDR: EU Medical Device Regulation – Chapter 8: Cooperation Between Member States, Medical Device Coordination Group, Expert Laboratories, etc.

Course ID: ELM-324
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training EU MDR: EU Medical Device Regulations - Chapter 10: Final Provisions
Individual Course w/Certificate of Completion:

EU MDR: EU Medical Device Regulations – Chapter 10: Final Provisions

Course ID: ELM-326
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training MDSAP: Medical Device Single Audit Program - Part 1 of 3
Individual Course w/Certificate of Completion:

MDSAP: Medical Device Single Audit Program – Part 1 of 3

Course ID: ELM-135
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training MDSAP: Medical Device Single Audit Program - Part 2 of 3
Individual Course w/Certificate of Completion:

MDSAP: Medical Device Single Audit Program – Part 2 of 3

Course ID: ELM-136
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training MDSAP: Medical Device Single Audit Program - Part 3 of 3
Individual Course w/Certificate of Completion:

MDSAP: Medical Device Single Audit Program – Part 3 of 3

Course ID: ELM-137
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training MDSAP: Medical Device Single Audit Program - Chapters 1 to 4
Individual Course w/Certificate of Completion:

MDSAP: Medical Device Single Audit Program – Chapters 1 to 4

Course ID: ELM-138
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training MDSAP: Medical Device Single Audit Program - Chapters 5 to 7
Individual Course w/Certificate of Completion:

MDSAP: Medical Device Single Audit Program – Chapters 5 to 7

Course ID: ELM-139
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training MDSAP: Country Specific Requirements for USA
Individual Course w/Certificate of Completion:

MDSAP: Country Specific Requirements for USA

Course ID: ELM-143
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training MDSAP: Country Specific Requirements for Canada
Individual Course w/Certificate of Completion:

MDSAP: Country Specific Requirements for Canada

Course ID: ELM-142
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training MDSAP: Country Specific Requirements for Australia
Individual Course w/Certificate of Completion:

MDSAP: Country Specific Requirements for Australia

Course ID: ELM-140
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00



Pharmaceutical Microbiology


Certification Training Pharmaceutical Microbiology and Industry Considerations
Individual Course w/Certificate of Completion:

Pharmaceutical Microbiology and Industry Considerations

Course ID: ELM-711
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training Microbiological Testing Methods
Individual Course w/Certificate of Completion:

Microbiological Testing Methods

Course ID: ELM-721
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training Microbial Contamination of Pharmaceutical Products - Part 1
Individual Course w/Certificate of Completion:

Microbial Contamination of Pharmaceutical Products – Part 1

Course ID: ELM-705
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Microbial Contamination of Pharmaceutical Products - Part 2
Individual Course w/Certificate of Completion:

Microbial Contamination of Pharmaceutical Products – Part 2

Course ID: ELM-706
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training Control of Microbiological Contamination in a GMP Environment
Individual Course w/Certificate of Completion:

Control of Microbiological Contamination in a GMP Environment

Course ID: ELM-720
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training Microbiological Environmental Monitoring
Individual Course w/Certificate of Completion:

Microbiological Environmental Monitoring

Course ID: ELM-719
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00



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



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


Certification Training Process Validation: Introduction to Process Validation - Part 1 of 2
Individual Course w/Certificate of Completion:

Process Validation: Introduction to Process Validation – Part 1 of 2

Course ID: ELM-401
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training Process Validation: Introduction to Process Validation - Part 2 of 2
Individual Course w/Certificate of Completion:

Process Validation: Introduction to Process Validation – Part 2 of 2

Course ID: ELM-402
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training MedDev: Introduction to Medical Device Validation (Part 1 of 3)
Individual Course w/Certificate of Completion:

MedDev: Introduction to Medical Device Validation (Part 1 of 3)

Course ID: ELM-156
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training MedDev: Introduction to Medical Device Validation (Part 2 of 3)
Individual Course w/Certificate of Completion:

MedDev: Introduction to Medical Device Validation (Part 2 of 3)

Course ID: ELM-157
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training MedDev: Introduction to Medical Device Validation (Part 3 of 3)
Individual Course w/Certificate of Completion:

MedDev: Introduction to Medical Device Validation (Part 3 of 3)

Course ID: ELM-158
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training Equipment Validation: How to Perform Supplier Qualification
Individual Course w/Certificate of Completion:

Equipment Validation: How to Perform Supplier Qualification

Course ID: ELM-107
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training Equipment Validation: Introduction to Risk Based Equipment Qualification
Individual Course w/Certificate of Completion:

Equipment Validation: Introduction to Risk Based Equipment Qualification

Course ID: ELM-121
Method of Training: Online, self-paced eLearning.
Length: 60 minutes
Price: $199.00


Certification Training Equipment Validation: How to Perform a Failure Mode Effect Analysis (FMEA) - Part 1
Individual Course w/Certificate of Completion:

Equipment Validation: How to Perform a Failure Mode Effect Analysis (FMEA) – Part 1

Course ID: ELM-128
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Equipment Validation: How to Perform a Failure Mode Effect Analysis (FMEA) - Part 2
Individual Course w/Certificate of Completion:

Equipment Validation: How to Perform a Failure Mode Effect Analysis (FMEA) – Part 2

Course ID: ELM-129
Method of Training: Online, self-paced eLearning.
Length: 45 minutes
Price: $199.00


Certification Training Commissioning, Qualification & Validation: The Concept of CQV - Part 1
Individual Course w/Certificate of Completion:

Commissioning, Qualification & Validation: The Concept of CQV – Part 1

Course ID: ELM-181
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training Commissioning, Qualification & Validation: The Concept of CQV - Part 2
Individual Course w/Certificate of Completion:

Commissioning, Qualification & Validation: The Concept of CQV – Part 2

Course ID: ELM-182
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


Certification Training Commissioning, Qualification & Validation: The Concept of CQV - Part 3
Individual Course w/Certificate of Completion:

Commissioning, Qualification & Validation: The Concept of CQV – Part 3

Course ID: ELM-183
Method of Training: Online, self-paced eLearning.
Length: 30 minutes
Price: $199.00


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.