Key Aspects of the Trial Master File and How to Pass FDA Inspection 2011
conferences > Education, Training conferences > Key Aspects of the Trial Master File and How to Pass FDA Inspection
3 November, 2011
Palm Beach FL , USA
The session will give you practical solutions to get the best results from an audit and the opportunity to grow the image of your team and/or your site.
Areas Covered in the Session:
ICH guidelines and Good Clinical Practice (GCP)
Role and responsibilities of clinical trial staff
Key aspects of the Trial Master File
Understanding compliance
Most frequent audit findings
Audit preparation
Responding to audit findings
Developing a CAPA
Who Will Benefit:
Clinical Trial Sponsors Study Team
CROs Study Team / Study Managers
Clinical Team Leads
CRAs
Principal Investigators
Site Managers and Study Coordinators
New Clinical Research Coordinators
New Principal Investigators
Regulatory Compliance Associates and Managers
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
[email protected]
http://www.globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884
Areas Covered in the Session:
ICH guidelines and Good Clinical Practice (GCP)
Role and responsibilities of clinical trial staff
Key aspects of the Trial Master File
Understanding compliance
Most frequent audit findings
Audit preparation
Responding to audit findings
Developing a CAPA
Who Will Benefit:
Clinical Trial Sponsors Study Team
CROs Study Team / Study Managers
Clinical Team Leads
CRAs
Principal Investigators
Site Managers and Study Coordinators
New Clinical Research Coordinators
New Principal Investigators
Regulatory Compliance Associates and Managers
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
[email protected]
http://www.globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884
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Key Aspects of the Trial Master File and How to Pass FDA Inspection 3 November, 2011
