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Thursday, March 21, 2019
Home » GCP: Preparing for an Audit or Inspection

GCP: Preparing for an Audit or Inspection (GCP06)

Certification Training
Duration: 2 hours, Online (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.

BioPharma Institute LogoTraining Program: GCP: Preparing for an Audit or Inspection
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment. BioPharma Institute ReviewsClinical 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.

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


Professional Designation in Clinical Trials Management: For Clinical Research Associates, Project Managers, and Clinical Managers. ... Learn more

Professional Designation in Good Clinical Practice: For Clinical Research Associates, Project Managers, and Clinical Managers. ... Learn more

COURSE OUTLINE:


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.

COURSE OBJECTIVES:


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

Online Training Program Benefits:

  • 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
  • Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
  • Corporate LMS solutions: 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 may 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 Support@BioPharmaInstitute.com.

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