Complete List of Training Certification Programs
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AI Regulatory Compliance Management:
Expert-in-the-Loop (EIL) Certification Programs
Expert-in-the-Loop (EIL) Certification Programs
- Full List: AI Regulatory Compliance Management: Expert-in-the-Loop (EIL) Certification Programs
- Basic Skills – AI Regulatory Compliance Management: Expert-in-the-Loop (EIL) Professional Certification Program
- Advanced Skills – AI Regulatory Compliance Management: Expert-in-the-Loop (EIL) Professional Certification Program
- Specialty Skills – AI Regulatory Compliance Management: Expert-in-the-Loop (EIL) Professional Certification Program
- Introduction – AI Regulatory Compliance Management: Expert-in-the-Loop (EIL) Master Certification Program
Professional Certifications:
Free Introductory Webinar:
Clinical Research:
For Monitors, Coordinators, Investigators, CROs, & Sponsors
For Monitors, Coordinators, Investigators, CROs, & Sponsors
- Full List: Clinical Research Courses and Programs
- Clinical Trials Management Professional Certification
- CRA – Clinical Research Associate Professional Certification Program
- CRC – Clinical Research Coordinator Professional Certification Program
- Regulatory Affairs for Clinical Research (US & EU) Professional Certification Program
- GCP Training: Fundamental Courses for Clinical Researchers
- GCP & GxP Training Courses for Annual Employee Training
- Safety Reporting in Clinical Trials (Adverse Event Reporting)
- Clinical Trial eSystems Inspection Readiness
- Critical Thinking, Root Cause Analysis, and CAPAs
- Standard Operating Procedures (SOPs) in the GxP Regulated Industry
- Quality Risk Management (QRM) Awareness: Identifying Risks in Daily Operations
- Sponsors & CROs: Clinical Trials for Regulatory Professionals
- CRAs: Monitoring Training for Clinical Research Associates
- CRCs: Training for Clinical Research Coordinators
- Informed Consent: FDA 21 CFR Part 50 Subpart B
- HIPAA & GDPR Training for the Clinical Research Professional
- ISO 14155:2020 – Clinical Research of Medical Devices Standard
Professional Certifications:
Subcategories (Areas of specialty or focus):
cGMP:
Current Good Manufacturing Practice
Current Good Manufacturing Practice
- Full List: cGMP Courses and Programs
- cGMP Professional Certification (Pharmaceuticals)
- GMP: Food Manufacturing for Professionals (21 CFR Part 117)
- GMP Training: Fundamental Courses for Drug Manufacturers
- cGMP and GxP Refresher Courses for Annual Employee Training
- cGMP and GxP for Beginners (Onboarding new Employees)
- cGMP: Quality Assurance and Quality Control
- Standard Operating Procedures (SOPs) in the GxP Regulated Industry
- Quality Risk Management (QRM) Awareness: Identifying Risks in Daily Operations
- cGMP for Intermediate Employees
- cGMP for Food Manufacturing Employees
- Root Cause Analysis & CAPA
- FDA 21 CFR Part 117 Courses (cGMP for Food)
- FDA 21 CFR Part 111 Courses (cGMP for Dietary Supplements)
Professional Certifications:
Subcategories (Areas of specialty or focus):
GLP:
Good Laboratory Practice
Good Laboratory Practice
- Full List: Good Laboratory Practice (GLP) Courses and Programs
- Good Laboratory Practice (GLP) Professional Certification Program
- GPP: Good Pharmacoepidemiology Practice Professional Certification Program
- Pharmacokinetics and Pharmacodynamics for Professionals
- Introduction to Good Laboratory Practice (GLP)
- Standard Operating Procedures (SOPs) in the GxP Regulated Industry
- Quality Risk Management (QRM) Awareness: Identifying Risks in Daily Operations
- Good Laboratory Practice (GLP)
- G(QC)LP: Good Quality Control Laboratory Practice
- GLP: Stability Testing Programs (Pharmaceuticals)
- GLP: Sampling Plans (Pharmaceuticals)
- Conducting Pharmacokinetic and Pharmacodynamic Studies
- Pharmacokinetics and Pharmacodynamics in Drug Development & Registration
- Validation: Commissioning and Installation Qualification (IQ)
- Validation: Operational and Performance Qualification (OQ/PQ)
Professional Certifications:
Subcategories (Areas of specialty or focus):
Drug Safety:
Pharmacovigilance, Pharmacokinetics, & Pharmacodynamics
Pharmacovigilance, Pharmacokinetics, & Pharmacodynamics
- Full List: Drug Safety, Pharmacovigilance, Pharmacokinetics, and Pharmacodynamics Courses and Programs
- Drug Safety and Pharmacovigilance Professional Certification Program
- GPP: Good Pharmacoepidemiology Practice Professional Certification Program
- Pharmacokinetics and Pharmacodynamics for Professionals
- Introduction to Drug Safety and Pharmacovigilance
- Safety Reporting in Clinical Trials (Adverse Event Reporting)
- GPP: Good Pharmacoepidemiology Practice
- Conducting Pharmacokinetic and Pharmacodynamic Studies
- Pharmacokinetics and Pharmacodynamics in Drug Development & Registration
Professional Certifications:
Subcategories (Areas of specialty or focus):
Data Integrity & GDocP:
Good Documentation Practice & ALCOA
Good Documentation Practice & ALCOA
- Full List: Data Integrity & Good Documentation Practice (GDocP) Courses
- Data Integrity (ALCOA and ALCOA+)
- GDocP: Good Documentation Practice
- FDA 21 CFR Part 11: Electronic Records & Electronic Signatures
Subcategories (Areas of specialty or focus):
FDA 21 CFR Part 11:
Electronic Records & Electronic Signatures
Electronic Records & Electronic Signatures
- Full List: 21 CFR Part 11 Courses and Programs
- Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures)
- Validation: Computer System Validation (Part 1 of 2) (Planning)
- Validation: Computer System Validation (Part 2 of 2) (Implementation)
- Clinical Trial eSystems Inspection Readiness
- Overview of 21 CFR Part 54 Financial Disclosure & Part 11 Electronic Data Signatures
Subcategories (Areas of specialty or focus):
Medical Devices:
GMP, Audits, Validation, & Regulatory Affairs
GMP, Audits, Validation, & Regulatory Affairs
- Full List: Medical Devices Courses and Programs
- Regulatory Affairs: Introduction to the Regulation of Medical Devices
- Quality Management System Requirements for Medical Devices under ISO 13485:2016 and FDA QMSR
- ISO 14155:2020 Clinical Research of Medical Devices Standard
- Root Cause Analysis & CAPA
- cGMP and GxP Refresher Courses for Annual Employee Training
- cGMP and GxP for Beginners (Onboarding new Employees)
- cGMP for Intermediate Employees
Subcategories (Areas of specialty or focus):
Quality Assurance (QA):
Pharmaceuticals & Medical Devices
Pharmaceuticals & Medical Devices
- Full List: Quality Assurance (QA) Courses and Programs
- cGMP Professional Certification (Pharmaceuticals)
- cGMP: Quality Assurance and Quality Control (QA/QC)
- Root Cause Analysis & CAPA
Professional Certifications:
Subcategories (Areas of specialty or focus):
Regulatory Affairs:
Pharmaceuticals, Medical Devices, & Clinical Research
Pharmaceuticals, Medical Devices, & Clinical Research
- Full List: Regulatory Affairs Courses and Programs
- Global Pharmaceutical Regulatory Affairs Professional Certification Program
- US Pharmaceutical Regulatory Affairs Professional Certification Program
- Clinical Trials Management (US & EU) Professional Certification Program
- Regulatory Affairs for Clinical Research (US & EU) Professional Certification Program
- Introduction to the Regulation of Medical Devices
- Regulatory Affairs for Human Medicinal Products (EU and US)
- MRP – The Mutual Recognition Procedure
- CTD – Preparing Submissions in the Common Technical Document Format
- eCTD – Electronic Common Technical Document
- DCP – The Decentralized Procedure
- NDA – Submitting a New Drug Application: Obtain Approval to Market in the US
- Registration of Drugs Based on Monoclonal Antibodies
- How to Gain Approval to Market Generic Drugs in the US
- The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA
Professional Certification:
Subcategories (Areas of specialty or focus):
Selling and Marketing:
Pharmaceuticals in the USA
Pharmaceuticals in the USA
- Full List: Pharmaceutical Sales and Marketing
- Pharmaceutical Sales & Marketing Professional Certification
- Legal and Regulatory Framework for Advertising and Promotion of Prescription Drugs in the USA
- Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USA
- Consumer-directed Advertising and Online Promotion of Prescription Drugs in the USA
- Marketing of Prescription Drugs in the USA- Interactions with Healthcare Professionals
Professional Certification:
Subcategories (Areas of specialty or focus):
Validation:
Computer, Software, Process, Equipment, & Qualification
Computer, Software, Process, Equipment, & Qualification
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Full List: Validation Courses and Programs
- Pharmaceutical Validation Management Professional Certification Program
- Computer Software Assurance (CSA) Professional Certification Program
- Computer System Validation for Professionals
- Validation & Compliance: Commercial-off-the-shelf (COTS), Software-as-a-service (SaaS) and Cloud Systems
- CSA: Computer Software Assurance
- Commissioning and Installation Qualification (IQ)
- Operational and Performance Qualification (OQ/PQ)
- Equipment Cleaning Validation
- Root Cause Analysis & CAPA
Full List: CSV: Computer System Validation Courses and Programs
Professional Certifications:
Subcategories (Areas of specialty or focus):
