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Home » GCP: Preparing for an Audit or Inspection

GCP: Preparing for an Audit or Inspection (GCP006)

Certification Training
Rated 4.50/5
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Credits: 2.5 CPD Credits
Length of Course: Approximate time to complete this course is 2.5 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Clinical Trials Management and Monitoring.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $145.00

BioPharma Institute LogoTraining 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. BioPharma Institute Reviews

In order to ensure compliance with GCP (Good Clinical Practice), clinical trial sites of investigators and sponsors are subject to rigorous inspection by regulatory agencies. In this course, United States and European aspects are examined in the context of inspection/audit of the investigator's and sponsor's site. The differences between inspections and audits are explained in so much as how they affect the stages leading up to actual procedures. It gives an overview of the meaning of inspections/audits and takes the mystery out of the entire process through a breakdown to its original components.

This course discusses in detail the phases preceding a GCP inspection/audit. An adequate preparation in order to fully cooperate with inspectors/auditors means having an understanding of their goals and agendas. You must comprehend why specific functions, processes, and documentation are needed and what the inspector/auditor is looking for. This will greatly enhance the procedures involved in internal QA. Auditing assures both the sponsor and the agency that proper standards are being met, and that the sites are adequate for the undertaking of studies in clinical research.

The entire program must be viewed by students in order to pass. An online, multiple-choice final assessment score of 75% or better is required. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certificate of completion is immediately available.

Benefits of Getting Certified at BioPharma Institute

By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the BioPharma Institute provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The BioPharma Institute also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service. Changes to codes, regulations, etc. are taking place every day. You, your employees, and your colleagues need to be updated on as many of these as is humanly possible in order to stay current in the clinical research, pharmaceutical, and healthcare industries. Through learning tools such as books, recorded seminars, live seminars, online courses, and more, the BioPharma Institute offers proven methods that can help individuals/companies stay on top of those changes or learn aspects of the industry currently not in your/their repertoire.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at for more information.

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.

The GCP: Preparing for an Audit or Inspection course is found in the following professional certification program(s):

Clinical Trials Monitoring Professional Certification Program: GCP, or Good Clinical Practice, refers to a set of scientific and ethical quality standards for reporting, recording, conducting, and designing trials that involve human subjects. GCP compliance ensures the wel ... Learn more

Clinical Trials Management (US & EU) Professional Certification Program: This online professional certification program is for regulatory affairs personnel, clinical managers, project managers, investigators, and clinical research associates and coordinators with the desire to grow ... Learn more


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.

The Investigator's audit/inspection: This session outlines which functions, processes and documentation are audited/inspected at the investigator's site and what personnel at the site need to be aware of in order to prepare.

The sponsor's audit/inspection: This session outlines which functions, processes and documentation are audited/inspected at the sponsor's site and what personnel at the site need to be aware of in order to prepare.

Audit/inspection of external suppliers: This session focuses on the arrangements that need to be in place between sponsors and external suppliers to ensure that causes for concern affecting audits/ inspections are properly managed.

Tools and case studies: Case studies help to review newly acquired knowledge and set it in a realistic context. An audit/ inspection checklist is also provided as reference material.


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

All Courses in the Clinical Trials Management and Monitoring Catalog:

GCP: ICH Good Clinical Practice (ICH-GCP): Many regulatory changes are happening in the pharmaceutical industry. Those who are particularly affected are individuals involved in research. When carrying out research duties, there is always the risk of bre ... Learn more

GCP: Clinical Trial Preparation and Design: Worldwide expenditure by pharmaceutical companies on research and development is continually increasing. In the production of a new drug, most of the financial investment is allocated to clinical trials. It is ... Learn more

GCP: Clinical Trials and Drug Development: This online course teaches the students about how clinical trials fit into the process of drug development. Key historical events which have led to the development of controlled clinical trials is outlined. The ... Learn more

GCP: Clinical Trial Monitoring: Site Evaluation and Set-up: Site evaluation and the set-up's purpose is to ensure that the site is fully prepared for the conduct of the clinical trial, facilitates to conduct the study, has adequate time and appropriately qualified staff ... Learn more

GCP: Clinical Trial Monitoring - Documentation and Closure: Once the initiation of a trial begins, the CRA (clinical research associate) has a crucial role which is to monitor the conduct of the trial, as well as the recorded data's integrity. This online course will fa ... Learn more

GCP: Preparing for an Audit or Inspection: In order to ensure compliance with GCP (Good Clinical Practice), clinical trial sites of investigators and sponsors are subject to rigorous inspection by regulatory agencies. In this course, United States and E ... Learn more

GCP: Application Process to Conduct FDA-regulated Clinical Trials in USA: The IND (Investigational New Drug) Application is a submission through which the sponsor seeks approval from the FDA (Food And Drug Administration) to conduct clinical studies with an investigational drug. This ... Learn more

GCP: How to Obtain Approval to Conduct Clinical Trials in the EU: Before each phase of clinical development, approval must be sought and gained for any sponsor desiring to conduct investigational drug clinical studies in the European Union. This online course enlightens regul ... Learn more

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, password and receipt of payment emailed instantly upon online enrollment
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
  • Self-paced courses: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
  • Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
  • Purchase orders (POs) accepted: If POs are required, request an invoice to start the procurement process
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications could be helpful for those seeking new careers or transitioning to different positions within their organization

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

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