Online Class: Research Quality: Handling Investigational Drug Products
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Research Quality: Handling Investigational Drug Products


Join Class : Research Quality: Handling Investigational Drug Products

Research Quality: Handling Investigational Drug Products
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Course Description

This course describes Good Clinical Practices requirements for the sponsor and the investigator as it relates to receiving, storing, dispensing, and returning or destroying investigational drug products. Additionally, attendees will learn how to do drug accountability, drug reconciliation and maintain the proper auditable records in case of FDA or regulatory agency inspection.
 
Who should attend?  This course is designed for all who interact with investigational drug supplies. Specifically, Clinical Monitors (i.e. CRAs), Research Coordinators, Investigators, Sub-Investigators, Auditors, Project Managers and Sponsors.
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Course Lessons

  1. Introduction to Handling Investigational Products : Attendees will learn how GMP applies in clinical research. Attendees will also learn the FDA requirements for sponsors and investigators handling investigational drug products. This course additionally provides a review of common clinical research terms f
  2. Labeling an Investigational Drug Product : This lesson will review the FDA and Health Canada Protection Branch content requirements for investigational product's label .
  3. Control of Investigational Drug Products : This class reviews the type of controls expected for investigational drug products.
  4. Storage and Environmental Monitoring : This class describes storage and documentation requirements for investigational products.
  5. Subject's Compliance and Accountability : This class shows how to calculate subjects' drug compliance and investigational product reconciliation. It also provides a sample inventory log.

Certificates & Merits Awarded

  1. Certificate of Attendance
  2. Certificate of Class Participation
  3. Certificate of Merit
  4. Certificate of Outstanding Achievement
  5. Certificate of Academic Excellence
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Additional Information

Course Number : 33637
Course Type : Professional (Intermediate Level)(non credit)
Course URL : http://qualitytrialsip.onlineclasses.com
Instructor : S. Wilson
Syllabus : View Syllabus
Duration : Countinous - Enroll Anytime!
Course Fee :
Basic Course: $35.00

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