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Searching courses for: CFR Part 820
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Training Programs by Category:
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
- Good Clinical Practice for Professionals
- 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
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)
- 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)
- 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)
Professional Certifications:
Subcategories (Areas of specialty or focus):
GLP:
Good Laboratory Practice & ALCOA
Good Laboratory Practice & ALCOA
- Full List: Good Laboratory Practice (GLP) Courses and Programs
- GLP: Good Laboratory Practice Professional Certification Program
- GLP: Data Integrity & ALCOA
- GLP: Preparing for Audits
- GLP: Organization, Roles, & Infrastructure
- Contamination Control & Aseptic Techniques
- Pharmaceutical Microbiology
Professional Certification:
Subcategories (Areas of specialty or focus):
Microbiology:
Contamination Control & Aseptic Techniques
Contamination Control & Aseptic Techniques
- Full List: Microbiology & Contamination Control Courses and Programs
- Pharmaceutical Microbiology Professional Certification Program
- Pharmaceutical Contamination Control Professional Certification Program
- Pharmaceutical Microbiology
- Contamination Control and Aseptic Techniques
- GLP: Good Laboratory Practice
Professional Certifictions:
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
- GVP: Good Pharmacovigilance Practice 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)
- GVP: Good Pharmacovigilance Practice
- 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 Professional Certification Program
- Good Documentation Practices (GDocP) Professional Certification Program
- 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
Professional Certifications:
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
- 21 CFR Part 11 Professional Certification
- Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures)
- 21 CFR Part 11: An Introduction
- 21 CFR Part 11: Electronic Signatures
Professional Certification:
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
- 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
- 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
Professional Certifications:
Subcategories (Areas of specialty or focus):
OSHA and HR EEO:
Safety Training for Healthcare, Clinical, & Medical Professionals
Safety Training for Healthcare, Clinical, & Medical Professionals
- Full List: OSHA for Healthcare / Medical Professionals
- OSHA for Healthcare Professionals
Full List: HR/EEO for Employees and Managers
Professional Program:
Quality Assurance (QA):
Pharmaceuticals & Medical Devices
Pharmaceuticals & Medical Devices
- Full List: Quality Assurance (QA) Courses and Programs
- 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)
- 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)
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
- 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
- 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 Certifications:
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
-
Full List: Validation Courses and Programs
- 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
- 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
Full List: CSV: Computer System Validation Courses and Programs
Professional Certifications:
Subcategories (Areas of specialty or focus):
