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Use this form to search course ID, name, description, outline, and objectives. This is a multiple word search. Each word must be 3 characters or more (e.g., GMP, GCP, Clinical, etc). Shorter words and any special characters will be ignored. You can search courses for things such as GMP001S1, GAMP, Pharmacovigilance, Quality Assurance, ALCOA, Validation, Clinical Trials, Cleaning Validation, or Drug Safety.
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Searching courses for: GAMP
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Validation & Compliance: Commercial-off-the-shelf (COTS), Software-as-a-service (SaaS) and Cloud SystemsLearn how to validate and maintain compliance for commercial-off-the-shelf (COTS), software-as-a-service (SaaS), and cloud systems in regulated environments. This course blends technical, regulatory, … Course ID: CSA-301 |
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Validation: Computer System Validation (Part 1 of 2) (Planning)Computerized systems in GMP-regulated environments must be validated to ensure reliability and compliance. This course focuses on the planning phase of Computer System Validation (CSV), guiding you th … Course ID: VAL09 |
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CSA: Computer Software AssuranceEmbrace the FDA's modern approach to Computer Software Assurance (CSA)-a risk-based, efficiency-focused evolution of traditional CSV. This course will help you focus validation efforts on what matters … Course ID: CSA-101 |
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AI Quality Regulatory Compliance Management Professional Certification ProgramThe AI Quality Regulatory Compliance Management Professional Certification Program is designed to prepare life sciences professionals for one of the most important emerging roles in regulated industry … Course ID: AI-201 |
On-Demand Training by Category:
AI Quality Management in GxP Regulated Industries:
Certification Programs for Professionals
Certification Programs for Professionals
- Full List: AI Quality Management in GxP Regulated Industries: Certification Programs
- AI Quality Regulatory Compliance Management Professional Certification Program
- AI Applications and Quality Management in GxP Environments
- AI Regulatory Compliance Management: Expert-in-the-Loop (EIL) Master Certification Program
- Validation & Compliance: Commercial-off-the-shelf (COTS), Software-as-a-service (SaaS) and Cloud Systems
Professional Certifications:
Subcategories (Areas of specialty or focus):
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):
