Online Training for
Introduction to Good Clinical Practices
Learn the key compliance drivers and regulatory requirements for your CAPA system. Understand the difference between a corrective and preventive action.
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The PathWise Good Clinical Practices (GCP) training module covers the international standard for organizations involved in clinical trials or studies. This one hour training will help you understand GCP, including the recent updates to the regulations in E6(R2), ICH E6(R1), how the regulation came to be, and why they are essential for your organization. This training will support those involved in the design, execution of clinical trials, and help them understand what is important to maintain quality data and patient safety.
Training is done through epath, the PathWise online learning management system. ePath is on-Demand e-learning for targeted knowledge-based learning. Our knowledge-based Web Based Training focuses on terms, definitions, regulations and expectations.
The PathWise Good Clinical Practices Training covers the following areas:
- Why GCP are essential.
- Key Principles for maintaining safety for trial subjects.
- Roles and Responsibilities of the trial investigator and Sponsor.
- Which topics are needed in trial protocol.
Benefits of the GCP web training includes:
- Optimize productivity and training time, with 1-2 hour training
- Utilize flexible mobile learning using a desktop, laptop, tablet or mobile device to take the training.
- Fulfill new hire and annual FDA training requirements with corporate packages.
- Understand the roles and Responsibilities of involved parties.
- Know the key areas needed in the risk based quality management system.
This training is appropriate for all employees involved in designing, conducting, recording, and reporting trials that involve the participation of Human subjects.
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Continuing Education Credit
The Introduction to Good Clinical Practices online training module is worth 0.1 CEU credits.
PathWise is accredited by the International Association for Continuing Education and Training (IACET). PathWise complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, PathWise is accredited to issue the IACET CEU.
Learners must complete the following in order to earn CEU credit:
- Verify your electronic signature
- Complete the full course module on ePath
- Complete the full instruction module
- Complete the post course assessment on ePath with an 80% score or better (learner will be given 2 opportunities to take the assessment).
Additional Online Modules
|WEB BASED TRAINING FOR COMPLIANCE
|WEB BASED TRAINING FOR QUALITY SYSTEMS
|WEB BASED TRAINING FOR PRODUCTIVITY
|Introduction to Investigations & CAPA
|Effective Meeting Management
|Introduction to Technical Writing
|Introduction to Quality Change Control
|Introduction to Human Factors and Performance Web Based Training
|Good Clinical Practices
|Introduction to Quality Risk Management
|Electronic Records and Signatures
|EU MDR 2017/745
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