|Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
THIS COURSE IS CURRENTLY NOT AVAILABLE.
Contact the BioPharma Institute for more information.
Training Program: GCP: Preparing for an Audit or Inspection
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment. Clinical trial sites of sponsors and investigators are subject to rigorous inspection by regulatory agencies to ensure compliance with Good Clinical Practice (GCP). Auditing assures the agency (and the sponsor) that good standards are being maintained and that the sites are fit for undertaking clinical research studies. Preparing adequately to cooperate with auditors/ inspectors requires an understanding of their agendas and goals. Understanding why specific documentation, processes and functions are checked and what the auditor/inspector is looking for will substantially enhance internal QA procedures. This online course explores the phases preceding a GCP audit/inspection. It gives an overview of what is meant by audits/inspections and demystifies the whole process by breaking it down to its original components. The differences between audits and inspections are explained in so far as they affect the stages leading up to the procedures themselves. European and US aspects are examined in the context of audit/inspection of the sponsor’s and of the investigator’s site.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.
Online Training Programs Include:
The GCP: Preparing for an Audit or Inspection course is found in the following professional certification program(s):
Introduction: This session explains the reasons for having audits/inspections, introduces the people involved in them and clarifies the general terminology and main differences between the US and European systems.
Students completing this course should be able to: Understand the reasons for audits and inspections. Explain what needs to be done prior to an audit/inspection of a sponsor’s site. Explain what needs to be done prior to an audit/inspection of an investigator’s site. Understand the audit/inspection of external supplier
For more information on the BioPharma Institute’s training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.