Archive: Final ICH GCP E6 R2: Sponsor Quality Management - Risk-Based/Risk Management Requirements and Approaches for Compliance
Jan 25, 2021, 20:23 PM
Course Id :
20798
Barnett Code :
BI13983
Date :
July 21, 2020
Conf Date :
Jul 21, 2020, 05:00 AM
Price :
835.00
Site License Price :
1835.00
ICH GCP E6 R2 provides significant detail on implementing a system of quality management with a focus on a risk-based/risk management approach for the trial, also referred to as Risk-Based Quality Management. This web seminar reviews this new sponsor requirement and describes the clinical quality management system (cQMS) that should be used to oversee quality during the design, conduct, recording, evaluation, reporting and archiving phases – notably the lifecycle of the clinical trial. Additionally, cQMS industry benchmarks, standards and practices will also be discussed.
- Describe two new requirements for the sponsor’s quality management (QM) of clinical trials
- Identify two approaches to achieve compliance with QM for the clinical trial lifecycle
- Determine next steps for evaluation and implementation of the new requirements
- Trial Managers
- Project Managers/Directors
- Clinical Quality
Assurance/Compliance Personnel
Nikki Christison, B.S., C.C.R.A.,T.I.A.C.R.
Click here for complete trainer
biographies
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.
Sort order :
2020072100000000
topics :
- Clinical Research
- Medical Device
- Regulatory Compliance
jobfunctions :
- Clinical Operations & Trial Management
- Clinical Quality Assurance
- Clinical Research Associate
- Regulatory Affairs
- Study Site Compliance
series :
- Clinical Trials & Translational Medicine
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