Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Clinical Trials Management and Monitoring.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $145.00
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.
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.
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):
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
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
- 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 Support@BioPharmaInstitute.com.