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Tuesday, February 21, 2017
Home » Online Training Course

Good Clinical Practice Professional Certification Program (GCP00A2)

Certification Training Duration: 16 hours (the average time to complete the training program, including final assessments).
Credits Hours: 16
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $1599.00


BioPharma Institute LogoThe Good Clinical Practice Professional Certification Program includes the following individual courses:




GCP: ICH Good Clinical Practice (ICH-GCP):
NOTE: This newly updated course includes quality eLearning delivery with voiceovers and illustrations.

The pharmaceutical industry is undergoing many regulatory changes. Those of us involved in research are directly affected. When carrying out our duties there is a risk of compromising the quality of data we generate and of breaching ethical codes. An understanding of the background and the principles of Good Clinical Practice are critical to ensure ethical research, high quality and credible data. This online course describes the key principles and structure of ICH GCP and, by using actual practitioner experience and accounts, provides a broad framework in which to apply the standards of Good Clinical Practice.

GCP: Clinical Trial Preparation and Design:
NOTE: This newly updated course includes quality eLearning delivery with voiceovers and illustrations.

Worldwide expenditure on R&D by the pharmaceutical industry is continually increasing. Most of the financial investment in the production of a new drug is allocated to clinical trials. To maintain profitability, it is essential to minimize the spiraling costs of research. Therefore, companies need to introduce measures to improve the efficiency and effectiveness of the clinical trial process. From a scientific perspective it is vital to obtain sufficient and accurate data.

GCP: Clinical Trials and Drug Development:
NOTE: This newly updated course includes quality eLearning delivery with voiceovers and illustrations.

This online course provides an understanding of how clinical trials fit into the drug development process. It outlines the key historical events leading to the development of controlled clinical trials. It specifies the purpose of trials, outlines their features, and identifies codes and regulations that apply to them. Finally, it describes the environment of cost control in which the modern pharmaceutical industry operates.

GCP: Clinical Trial Monitoring: Site Evaluation and Set-up:
NOTE: This newly updated course includes quality eLearning delivery with voiceovers and illustrations.

The purpose of site evaluation and set-up is to ensure that the site has access to the required patient population, has appropriately qualified staff, adequate time and facilities to conduct the study and to ensure the site is fully prepared for the conduct of the clinical trial. This online course provides an understanding of the training requirements for clinical research associates (CRAs), including familiarization with study documentation. The procedures necessary prior to initiation of an investigational site, particularly the site qualification visit, are described in detail. The responsibilities and procedures associated with preparing for and conducting initiation visits are also covered in detail.

GCP: Clinical Trial Monitoring – Documentation and Closure:
NOTE: This newly updated course includes quality eLearning delivery with voiceovers and illustrations.

Once a trial is initiated, the crucial role of the clinical research associate (CRA) is to monitor the conduct of the trial and the integrity of the data recorded. This online course introduces areas such as monitoring of case report forms (CRFs), source document verification and the review and maintenance of essential documents. The responsibilities and procedures associated with monitoring processes and close-out visits are also explained.

GCP: Preparing for an Audit or Inspection:
NOTE: This newly updated course includes quality eLearning delivery with voiceovers and illustrations.

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.


Training Provided By: BioPharma Institute


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