Archive: TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings
Oct 19, 2021, 12:20 PM
Course Id :
22385
Barnett Code :
BI14617
Date :
September 10, 2021
Conf Date :
Sep 10, 2021, 08:00 AM
Price :
835.00
Site License Price :
1835.00
Recently the EMA has published guidance in managing the TMF. FDA’s regulations are general and require that sponsors and investigators maintain adequate and accurate records of any clinical investigations that are carried out. This web seminar will examine these expectations and discuss recent regulatory findings. We will also discuss strategies for implementing corrective and preventive actions (CAPAs) that result in successful outcomes to regulatory findings associated with TMF inspections.
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- Explain regulatory expectations regarding TMF/eTMF management
- Identify two recent regulatory findings directed at TMF/eTMF management
- Describe strategies for preparing effective CAPAs that address regulatory findings
- Discuss plan for preparing for a regulatory inspection
- Good Clinical Practice Auditors and Quality Assurance Directors
- Trial Master File Directors, Managers, and Coordinators
- Clinical Operations Directors and Trial Managers
- Records Management Team Members
Donna W. Dorozinsky, R.N., M.S.N., C.C.R.C.
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 :
2021091000000000
topics :
- Clinical Research
- Medical Device
- Regulatory Compliance
jobfunctions :
- Clinical Operations & Trial Management
- Clinical Quality Assurance
- Clinical Research Associate
- Study Site Compliance
series :
- Clinical Trials & Translational Medicine
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