Archive: Drug Development and FDA Regulations

December 13, 2017 | Barnett International Recording

Web Seminar Archives are available in either USB Flash Drive or DVD Format.

Archives are also available in SCORM format for LMS integration. Please contact Barnett at (215) 413-2471 for more details and pricing on SCORM files.

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$735.00

Course Description

This web seminar provides an overview of the drug development process. Included are the Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) regulations and how they interact in the drug development process.

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Learning Objectives

  • Describe the FDA’s role in drug development
  • Review the logic behind the drug development process
  • Discuss IND/NDA submissions
  • Describe the basics of the clinical trial process
  • Describe the FDA review process for IND/NDA submissions
  • Navigate the three major FDA regulations: GCP, GLP and GMP

Who Should Attend

  • Those who want an understanding or greater understanding of the drug development process
  • Clinical Research Associates
  • Auditors
  • Regulatory Affairs Professionals
  • Quality Assurance Personnel
  • Manufacturing Personnel

Instructor

The course will be led by one of the following instructors:

Gary Freeman, M.S.

Click here for complete trainer biographies

 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.