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Good Clinical Practice (GCP) for Medical Devices

Prepare for Close Scrutiny During FDA Inspections!

This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com

Interactive Elements

Adults and professionals learn better when the classroom is a vibrant, stimulating place. That's why we incorporate discussions, exercises and quizzes into all of our courses. These activities reinforce training and foster a practical, hands-on educational experience.  

The following is one of several interactive elements incorporated in Good Clinical Practice (GCP) for Medical Devices.  Refer to the course agenda on pages 4 and 5 for additional examples.

Create an IRB Assessment Plan for Clinical Site Qualification  

Assumptions:

  • An academic medical center where you have no prior experience is being considered as a site for one of your clinical trials 
  • The IRB keeps its functions close to the vest

Exercise: 

  • Develop a plan to assess the adequacy of this site's IRB.
  • What would you examine before signing the contract?

Booking Options

This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com

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