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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, CFR Part 820, Cleaning Validation, or Drug Safety.

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Searching courses for: GAMP

(3 Programs Found)

	Individual Course w/Certificate of Completion: Validation: Computer System Validation (Part 1 of 2) (Planning) Enroll Here  Learn More This online program offers an introduction to the international principles and regulations behind computer systems validation. Course objectives include the following: to offer an understanding the co … (Read more) Course ID: VAL09 Average Learning Time: 60 minutes Price: $195.00
	Individual Course w/Certificate of Completion: CSA: Computer Software Assurance Enroll Here  Learn More The FDA’s approach to Computer System Assurance (CSA) represents a modernized perspective on computer system validation (CSV), aiming to ensure that systems used in the pharmaceutical, medical device, … (Read more) Course ID: CSA-101 Average Learning Time: 65 minutes Price: $145.00
	Training Program For Professionals: Computer System Validation for Professionals Enroll Here  Learn More Computer System Validation for Professionals program includes an introduction to the international principles and regulations behind effective validation and qualification. The program offers an intro … (Read more) Course ID: VAL00S2 Average Learning Time: See Program Webpage Price: $695.00

Training Programs by Category:

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
• Good Clinical Practice for Professionals

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
• QRM: Quality Risk Management
• Critical Thinking, Root Cause Analysis, and CAPAs
• 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)
• cGMP Professional Certification (Medical Devices)
• US Pharmaceutical Quality Assurance (QA) Management Professional Certification Program
• US Medical Device Quality Assurance (QA) Management Professional Certification Program
• GDP: Good Distribution Practice Professional Certification
• GMP Auditor Professional Certification Program
• FDA Inspection Readiness for Professionals
• cGMP for Intermediate Professionals
• 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
• cGMP for Intermediate Employees
• cGMP for Advanced Employees (Pharmaceuticals)
• cGMP for Advanced Employees (Medical Devices)
• cGMP for Food Manufacturing Employees (New Courses)
• cGMP for Combination Products – Pharmaceuticals & Medical Devices
• GDP: Good Distribution Practices
• QRM: Quality Risk Management
• Change Control
• Root Cause Analysis & CAPA
• FDA Inspection Readiness (GMP Auditing)
• FDA 21 CFR Part 211 Courses (Pharmaceuticals)
• FDA 21 CFR Part 820 Courses (Medical Devices)
• FDA 21 CFR Part 117 Courses (Food Mfg.)
• CFDA: China Food and Drug Administration (GMP for Medical Devices)

GLP:
Good Laboratory Practice & ALCOA

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

Professional Certification:
• GLP: Good Laboratory Practice Professional Certification Program

Subcategories (Areas of specialty or focus):

• GLP: Data Integrity & ALCOA
• GLP: Preparing for Audits
• GLP: Organization, Roles, & Infrastructure
• Contamination Control & Aseptic Techniques
• Pharmaceutical Microbiology

Microbiology:
Contamination Control & Aseptic Techniques

Full List: Microbiology & Contamination Control Courses and Programs

Professional Certifictions:
• Pharmaceutical Microbiology Professional Certification Program
• Pharmaceutical Contamination Control Professional Certification Program

Subcategories (Areas of specialty or focus):

• Pharmaceutical Microbiology
• Contamination Control and Aseptic Techniques
• GLP: Good Laboratory Practice

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
• GVP: Good Pharmacovigilance Practice 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)
• GVP: Good Pharmacovigilance Practice
• 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

Professional Certifications:
• Data Integrity Professional Certification Program
• Good Documentation Practices (GDocP) Professional Certification Program

Subcategories (Areas of specialty or focus):

• Data Integrity (ALCOA and ALCOA+)
• GDocP: Good Documentation Practice
• SOPs: How to Write Effective Standard Operating Procedures
• URS: How to Write an Effective Equipment User Requirement Specification
• 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

Professional Certification:
• 21 CFR Part 11 Professional Certification

Subcategories (Areas of specialty or focus):

• Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures)
• 21 CFR Part 11: An Introduction
• 21 CFR Part 11: Electronic Signatures

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

Full List: Medical Devices Courses and Programs

Professional Certifications:
• US Medical Device Quality Assurance (QA) Management Professional Certification Program
• FDA 21 CFR Part 820: Medical Device cGMP Professional Certification Program
• ISO 13485:2016 Professional Certification Program
• EU Medical Device Regulation (EU MDR) for Professionals
• Medical Device Single Audit Program (MDSAP) for Professionals
• Medical Device Validation for Professionals

Subcategories (Areas of specialty or focus):

• Regulatory Affairs: Introduction to the Regulation of Medical Devices
• EU MDR: EU Medical Device Regulation
• MDSAP: Medical Device Single Audit Program
• FDA 21 CFR Part 820: US cGMP for Medical Devices
• FDA Inspection Readiness (GMP Auditing)
• ISO 14971:2019 Medical Devices
• ISO 13485:2016 Medical Devices
• ISO 14155:2020 Clinical Research of Medical Devices Standard
• Validation: Medical Devices
• QRM: Quality Risk Management
• Change Control
• 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
• cGMP for Advanced Employees
• cGMP for Combination Products: Pharmaceuticals & Medical Devices
• China CFDA: cGMPs

OSHA and HR EEO:
Safety Training for Healthcare, Clinical, & Medical Professionals

Full List: OSHA for Healthcare / Medical Professionals
Full List: HR/EEO for Employees and Managers

Professional Program:
• OSHA for Healthcare Professionals

Quality Assurance (QA):
Pharmaceuticals & Medical Devices

Full List: Quality Assurance (QA) Courses and Programs

Professional Certifications:
• US Pharmaceutical Quality Assurance (QA) Management Professional Certification Program
• US Medical Device Quality Assurance (QA) Management Professional Certification Program
• cGMP Professional Certification (Pharmaceuticals)
• cGMP Professional Certification (Medical Devices)

Subcategories (Areas of specialty or focus):

• cGMP: Quality Assurance and Quality Control (QA/QC)
• Root Cause Analysis & CAPA
• QRM: Quality Risk Management
• FDA 21 CFR Part 211: US cGMP for Pharmaceuticals
• FDA 21 CFR Part 820: US cGMP for Medical Devices
• ISO 13485:2016 Chapter 4: The Quality Management System (QMS)
• ISO 13485:2016 Measurement Analysis and Improvement (Chapter 8, Part B)

Regulatory Affairs:
Pharmaceuticals, Medical Devices, & Clinical Research

Full List: Regulatory Affairs Courses and Programs

Professional Certifications:
• Global Pharmaceutical Regulatory Affairs Professional Certification Program
• US Pharmaceutical Regulatory Affairs Professional Certification Program
• Clinical Trials Management (US & EU) Professional Certification Program
• Obtaining Approval for Clinical Trials in US & EU for Professionals
• EU MDR: EU Medical Device Regulation for Professionals
• Medical Device Single Audit Program (MDSAP) for Professionals

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
• CSV: Computer System Validation Professional Certification
• CSA: Computer Software Assurance Professional Certification
• Process Validation for Professionals
• Medical Device Validation for Professionals
• Equipment Qualification for Professionals

Subcategories (Areas of specialty or focus):

• Process Validation
• Change Control
• Root Cause Analysis & CAPA
• Validation for Medical Devices
• Equipment Qualification
• CSA: Computer Software Assurance
• CSV: Computer System Validation for Beginners
• CSV: Computer System Validation for Intermediates

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