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Trial Master File (TMF): FDA Expectations from Sponsors and Sites

ComplianceOnline

Thursday, March 6, 2014 from 10:00 AM to 11:00 AM (EST)

Trial Master File (TMF): FDA Expectations from Sponsors and...

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Ticket Type Remaining Sales End Price Fee Quantity
Online Registration 20 Tickets Ended $199.00 $11.94

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Event Details

This training will review the essential elements of a TMF for clinical trials. The activities of set-up, maintenance, and monitoring will be discussed using case studies to highlight common deficiencies and potential solutions.

 

Why Should You Attend:

 

If you are involved in a clinical trial, either as a clinical site or a sponsor, this webinar will provide valuable suggestions about which documents are essential and which ones are not needed for an FDA audit. We will discuss common deficiencies identified by FDA auditors during review of TMFs and provide potential solutions to the same. We will also discuss issues related to the kind of products being tested, responsibilities of individuals, resources available, and projected trends for the near future.

 

Areas Covered in the Webinar:

 

  • FDA’s expectation from site and sponsor’s documents
  • Required components of a TMF
  • Best practices for the set-up and maintenance of TMF
  • Electronic and Paper TMF requirements
  • Common errors in TMF management

 

Who will benefit:

 

This webinar will provide valuable information to:

 

  • Clinical Research Associates (CRAs)
  • Clinical Research Coordinators (CRCs)
  • Clinical Research Administrators
  • Principal Investigators
  • Project Managers
  • Sponsors of INDs
  • People investing in FDA-regulated product development projects


For Registration:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=703078?channel=Eventbrite

Have questions about Trial Master File (TMF): FDA Expectations from Sponsors and Sites? Contact ComplianceOnline

When

Thursday, March 6, 2014 from 10:00 AM to 11:00 AM (EST)


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Organizer

ComplianceOnline

At ComplianceOnline, we are focused on :

 

  • Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
  • Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
  • Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
  • Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

 

 

 

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