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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: GMP001S1

(1 Programs Found)

Professional Certification Program: Current Good Manufacturing Practice (cGMP) Professional Certification Program Enroll Here  Learn More Advance Your Career with the cGMP Professional Certification Program Gain a powerful, in-depth understanding of Good Manufacturing Practice (GMP) for pharmaceuticals with this comprehensive certifica … (Read more) Course ID: GMP001S1 Average Learning Time: See Program Webpage Price: $1,795.00

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On-Demand Training by Category:

AI Quality Management in GxP Regulated Industries:
Certification Programs for Professionals

Full List: AI Quality Management in GxP Regulated Industries: Certification Programs

Professional Certifications:
• AI Quality Regulatory Compliance Management Professional Certification Program

Subcategories (Areas of specialty or focus):

• 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

Clinical Research:
For Monitors, Coordinators, Investigators, CROs, & Sponsors

Full List: Clinical Research Courses and Programs

Professional Certifications:
• 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

Subcategories (Areas of specialty or focus):

• 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

cGMP:
Current Good Manufacturing Practice

Full List: cGMP Courses and Programs

Professional Certifications:
• cGMP Professional Certification (Pharmaceuticals)
• GMP: Food Manufacturing for Professionals (21 CFR Part 117)

Subcategories (Areas of specialty or focus):

• 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)

GLP:
Good Laboratory Practice

Full List: Good Laboratory Practice (GLP) Courses and Programs

Professional Certifications:
• Good Laboratory Practice (GLP) Professional Certification Program
• GPP: Good Pharmacoepidemiology Practice Professional Certification Program
• Pharmacokinetics and Pharmacodynamics for Professionals

Subcategories (Areas of specialty or focus):

• 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)

Drug Safety:
Pharmacovigilance, Pharmacokinetics, & Pharmacodynamics

Full List: Drug Safety, Pharmacovigilance, Pharmacokinetics, and Pharmacodynamics Courses and Programs

Professional Certifications:
• Drug Safety and Pharmacovigilance Professional Certification Program
• GPP: Good Pharmacoepidemiology Practice Professional Certification Program
• Pharmacokinetics and Pharmacodynamics for Professionals

Subcategories (Areas of specialty or focus):

• 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

Data Integrity & GDocP:
Good Documentation Practice & ALCOA

Full List: Data Integrity & Good Documentation Practice (GDocP) Courses

Subcategories (Areas of specialty or focus):
• Data Integrity (ALCOA and ALCOA+)
• GDocP: Good Documentation Practice
• FDA 21 CFR Part 11: Electronic Records & Electronic Signatures

FDA 21 CFR Part 11:
Electronic Records & Electronic Signatures

Full List: 21 CFR Part 11 Courses and Programs

Subcategories (Areas of specialty or focus):
• 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

Medical Devices:
GMP, Audits, Validation, & Regulatory Affairs

Full List: Medical Devices Courses and Programs

Subcategories (Areas of specialty or focus):
• 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

Quality Assurance (QA):
Pharmaceuticals & Medical Devices

Full List: Quality Assurance (QA) Courses and Programs

Professional Certifications:
• cGMP Professional Certification (Pharmaceuticals)

Subcategories (Areas of specialty or focus):

• cGMP: Quality Assurance and Quality Control (QA/QC)
• Root Cause Analysis & CAPA

Regulatory Affairs:
Pharmaceuticals, Medical Devices, & Clinical Research

Full List: Regulatory Affairs Courses and Programs

Professional Certification:
• 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

Subcategories (Areas of specialty or focus):

• 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

Selling and Marketing:
Pharmaceuticals in the USA

Full List: Pharmaceutical Sales and Marketing

Professional Certification:
• Pharmaceutical Sales & Marketing Professional Certification

Subcategories (Areas of specialty or focus):

• 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

Validation:
Computer, Software, Process, Equipment, & Qualification

Full List: Validation Courses and Programs
Full List: CSV: Computer System Validation Courses and Programs

Professional Certifications:
• Pharmaceutical Validation Management Professional Certification Program
• Computer Software Assurance (CSA) Professional Certification Program
• Computer System Validation for Professionals

Subcategories (Areas of specialty or focus):

• 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

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