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GCP Training Programs

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Boost Your Team’s Performance with WCG Avoca Training

 

WCG Avoca offers training programs on a variety of topics to support clinical research professionals in their roles to provide high-quality clinical trials. Our three delivery methods of training tools enable flexibility, customization, and convenience:

 

Live Training Workshops

WCG Avoca fit-for-purpose training workshops are led by WCG Avoca’s Senior SMEs, industry experts with 25+ years of experience across Clinical Operations, Quality Assurance, and related disciplines. Workshops include but are not limited to, practical information for applying and complying with GCP guidelines, training sessions to ensure a common understanding of QTLs, and inspection readiness training as part of Mock Inspections.

Popular Training Topics: GCP Training, QTL Training, Partnership Assessment and Training, Inspection Readiness Training & More

AQC Member Advantage: Live training workshops will incorporate references to the AQC Knowledge Center identifying materials to support compliance and applying leading practices

 

 

Custom Training Content

WCG Avoca designs customized training content aimed to help you build and retain a team that is well versed in those areas most important to your specific clinical trial execution needs. All developed training assets are easily integrated into already established Learning Management Systems for future use.

AQC Member Advantage: Gain access to tools, templates, and leading practices needed to conduct clinical trials to ensure proactive quality management and inspection readiness

 

 

On-Demand Web Based Training

WCG Avoca offers on-demand web based training programs on a variety of topics to support clinical research professionals in their roles to provide high-quality clinical trials. This training solution is easy to deploy, and saves time and money. Each program is broken down into courses with interactive lessons to ensure attendees are engaged and comprehending key information. WCG Avoca’s solution is a flexible and convenient way to train teams.

Popular Training Topics: Sponsor Training, Site Training, Regulatory, Inspection Readiness & More

AQC Member Advantage: 10% Discount on all on-demand training

Download Web Based Training PDF

 

Overview of On-Demand Web Based Training Programs

 

 

Our on-demand training programs utilize the InvestigatorSpace training platform. InvestigatorSpace is designed by a team of software engineers specifically for use in the pharmaceutical and clinical trial fields. The system is used around the globe by industry professionals at clinical sites, sponsor, and research organizations. All training activity is logged and monitored, and training certifications are available for download by the end-users. Comprehensive Training Reports are also available for training monitoring and audit history.

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Program Details and Courses

 

WCG Avoca offers on-demand training on 11 program topics. Please reach out for more information on our course offerings and pricing. WCG Avoca Quality Consortium (AQC) Members get a discounted rate for all Training Programs.

 

1) Sponsor Training Program

This program focuses on foundational sponsor training offerings, providing an inclusive curriculum that contributes to a culture of quality and compliance in clinical trial conduct.

For: Sponsors/CROs

▾ Click to view 26 courses
  1. GCP/ICH Obligations of Sponsors, Monitors, and Investigators
  2. GCP/ICH Obligations of Sponsors and Monitors
  3. HIPAA-The Impact on Clinical Research
  4. Ethics as the Foundation to Clinical Research
  5. Overview of Clinical Research Process
  6. Selecting and Managing Clinical Contract Research Organizations (CROs)
  7. Informed Consent
  8. Drug Safety and Adverse Event Reporting
  9. Ethical Review Boards
  10. European Union Clinical Trials Regulation
  11. The Role of the Clinical Research Associate
  12. ISO 14155: Obligations of Sponsors and Monitors
  13. Clinical Trial Audits and Consequences of Noncompliance
  14. Good Clinical Practices (GCPs) for New Product Investigations
  15. ISO 14155: Clinical Investigation of Medical Devices for Human Subjects- Good Clinical Practice
  16. The Clinical Development Process: Investigational Product, Plan, and Data Management
  17. Laboratory Specimens for Clinical Research
  18. Investigational Product Development
  19. Aspects of Regulatory History
  20. Protection of Human Subjects in Clinical Trials
  21. Overview of FDA’s Bioresearch Monitoring Program
  22. Management Responsibility for Quality: What FDA Expects
  23. A Tour of Health Canada
  24. GxPs
  25. A Tour of FDA
  26. Clinical Research Associate/Study Monitor Program

 

2) Introduction to Research Training Program

This program teaches those who are new to the clinical research space the basics of clinical trial execution as it relates to quality, compliance, and patient safety.

For: Biotech companies embarking on their first clinical trial

▾ Click to view 17 courses
  1. GCP/ICH Obligations of Sponsors, Monitors, and Investigators
  2. HIPAA-The Impact on Clinical Research
  3. Ethics as the Foundation to Clinical Research
  4. Overview of Clinical Research Process
  5. Informed Consent
  6. Drug Safety and Adverse Event Reporting
  7. Ethical Review Boards
  8. The Role of the Clinical Research Associate
  9. The Role of the Clinical Research Coordinator
  10. Clinical Trial Audits and Consequences of Noncompliance
  11. Laboratory Specimens for Clinical Research
  12. Investigational Product Development
  13. Aspects of Regulatory History
  14. The Clinical Development Process: Investigational Product, Plan, and Data Management
  15. Protection of Human Subjects in Clinical Trials
  16. GxPs
  17. A Tour of FDA

 

3) Good Clinical Practice Training Program

This program is for organizational routine GCP training and GCP training for study staff.

For: Sponsors, CROs, Sites

▾ Click to view 5 courses
  1. GCP/ICH Obligations of Sponsors, Monitors, and Investigators
  2. GCP/ICH Obligations of Investigators Conducting Clinical Trials
  3. GCP/ICH Obligations of Sponsors and Monitors
  4. Good Clinical Practices (GCPs) for New Product Investigations
  5. GxPs

 

4) Global Research Training Program

This program is for those involved in global clinical research at Sponsors, CROs, and Sites.

For: Regulatory Affairs/Compliance Roles, Sponsors, CROs, Sites

▾ Click to view 8 courses
  1. GCP/ICH Obligations of Sponsors, Monitors, and Investigators
  2. GCP/ICH Obligations of Investigators Conducting Clinical Trials
  3. GCP/ICH Obligations of Sponsors and Monitors
  4. European Union Clinical Trials Regulation
  5. Overview of FDA’s Bioresearch Monitoring Program
  6. Management Responsibility for Quality: What FDA Expects
  7. A Tour of Health Canada
  8. A Tour of FDA

 

5) Site Training Program

This program focuses on foundational site training offerings, providing an inclusive curriculum that contributes to a culture of quality and compliance in clinical trial conduct.

For: Research Sites

▾ Click to view 25 courses
  1. GCP/ICH Obligations of Sponsors, Monitors, and Investigators
  2. GCP/ICH Obligations of Investigators Conducting Clinical Trials
  3. Obligations of Investigators in Conducting Medical Device Trials
  4. HIPAA-The Impact on Clinical Research
  5. Ethics as the Foundation to Clinical Research
  6. Overview of Clinical Research Process
  7. Informed Consent
  8. Drug Safety and Adverse Event Reporting
  9. Ethical Review Boards
  10. European Union Clinical Trials Regulation
  11. The Role of the Clinical Research Coordinator
  12. ISO 14155: Obligations of Sponsors and Monitors
  13. Clinical Trial Audits and Consequences of Noncompliance
  14. Good Clinical Practices (GCPs) for New Product Investigations
  15. ISO 14155: Clinical Investigation of Medical Devices for Human Subjects- Good Clinical Practice
  16. The Clinical Development Process: Investigational Product, Plan, and Data Management
  17. Laboratory Specimens for Clinical Research
  18. Investigational Product Development
  19. Aspects of Regulatory History
  20. Protection of Human Subjects in Clinical Trials
  21. Overview of FDA’s Bioresearch Monitoring Program
  22. Management Responsibility for Quality: What FDA Expects
  23. A Tour of Health Canada
  24. GxPs
  25. A Tour of FDA

 

6) Regulatory Training Program

This program is for regulatory and compliance professionals or anyone desiring to have a solid research regulatory training program.

For: Sponsors/CROs/Sites, Regulatory and Compliance Professionals

▾ Click to view 16 courses
  1. Obligations of Investigators in Conducting Medical Device Trials
  2. HIPAA-The Impact on Clinical Research
  3. Informed Consent
  4. Drug Safety and Adverse Event Reporting
  5. Ethical Review Boards
  6. European Union Clinical Trials Regulation
  7. ISO 14155: Obligations of Sponsors and Monitors
  8. Clinical Trial Audits and Consequences of Noncompliance
  9. Investigational Product Development
  10. Aspects of Regulatory History
  11. ISO 14155: Clinical Investigation of Medical Devices for Human Subjects- Good Clinical Practice
  12. Protection of Human Subjects in Clinical Trials
  13. Overview of FDA’s Bioresearch Monitoring Program
  14. Management Responsibility for Quality: What FDA Expects
  15. A Tour of Health Canada
  16. A Tour of FDA

 

7) Inspection Readiness Training Program

This program is for any team desiring to stay inspection ready.

For: Sponsors/CROs/Sites

▾ Click to view 7 courses
  1. Obligations of Investigators in Conducting Medical Device Trials
  2. European Union Clinical Trials Regulation
  3. Clinical Trial Audits and Consequences of Noncompliance
  4. Overview of FDA’s Bioresearch Monitoring Program
  5. Management Responsibility for Quality: What FDA Expects
  6. A Tour of Health Canada
  7. A Tour of FDA

 

8) Medical Device Training Program

This program is for those who are new to or need brushing up on medical device regulations. Upon completing this program, attendees will be able to recognize the requirements for conducting medical device research and identify recommended procedures to follow during a regulatory authority inspection of medical device trials including the ability to recognize the consequences of noncompliance.

For: Medical Device Professionals at Sponsors/CROs/Sites

▾ Click to view 3 courses
  1. Obligations of Investigators in Conducting Medical Device Trials
  2. ISO 14155: Obligations of Sponsors and Monitors
  3. ISO 14155: Clinical Investigation of Medical Devices for Human Subjects- Good Clinical Practice

 

9) Research Quality Management Training Program

This program is for research quality professionals or those planning to implement or maintain a quality management system. It provides key foundational elements for focus on GCP quality management systems and processes.

For: Sponsors/CROs/Sites, Quality Professionals, Operational Leaders

▾ Click to view 1 course
  1. Management Responsibility for Quality: What FDA Expects

 

10) Research Ethics

This program is for those seeking foundational research ethics training.

For: New or Routine IRB/EC Professional Training, Sponsors/CROs/Site Professionals

▾ Click to view 4 courses
  1. Ethics as the Foundation to Clinical Research
  2. Informed Consent
  3. Drug Safety and Adverse Event Reporting
  4. Ethical Review Boards

 

11) FSP/Vendor Management

This program is for those individuals who are involved in any level of vendor selection, qualification, management, and oversight. It highlights key ICH regulations and best practices in the vendor management lifecycle.

For: Sponsors/CROs/Sites, Vendor Management Professionals

▾ Click to view 1 course
  1. Selecting and Managing Clinical Contract Research Organizations (CROs)

 

 

WCG Avoca enables clinical service providers to accelerate their employees’ learning and stay up to date on the latest industry regulations and standards.

 

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Contact us to discuss your training needs:

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