Pharma / BiotechMedical Device
This GCP training course provides a solid understanding of GCP requirements and clinical quality assurance in detecting fraud and misconduct in clinical trials. Attendees will gain experience in detecting, correcting, and preventing clinical study misconduct and fraud at domestic and international clinical sites.
Additionally, attendees will learn how to ensure that their study conduct and supporting documentation is accurate and factual. The course will also address how to uncover misconduct, as well as, dealing with its consequences, while identifying proactive solutions to prevent further problems. Included in the course work are practical examples and a roadmap for evaluating study conduct, source documents, case report forms and other study documentation through presentation and interactive case studies.
Additionally, the course will cover methods to detect misconduct and deal with fraud in clinical trials by:
1. This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
2. This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.
A GCP audit can lead to the detection of problems with the conduct of the clinical trial. It is important to understand the differences between lack of knowledge and poor execution versus actual misconduct and fraud. This two-day course will discuss some of the common issues seen in clinical trials, how to handle problem findings, and how to distinguish between poor performance and misconduct.
This GCP training course will benefit those involved in the monitoring and/or QA of clinical trials. Attendees who work for Pharmaceutical or Biotech firms, Medical Device companies, Contract Research Organizations (CRO), Institutional Review Boards (IRBs), and academic institutions involved with the supervision or oversight of clinical trial practices and quality will find this course to be highly beneficial.
Session 1-Defining the Basic Requirements of GCP
Session 2-Industry Overview – FDA Regulatory Requirements – Are You Ready for an FDA Inspection?
Session 3-The Different Types of Audits
Session 4-Role of Monitoring in Detecting Misconduct
Session 5-Conducting GCP Audits
Session 6-FDA BIMO Inspections
Session 7-Preventing Fraud and Scientific Misconduct
Session 8-Non-FDA audits
Session 8-Case examples of misconduct and fraud
Upon completion, attendees will be able to:
Case study analysis, exercises and videos will be used throughout the course to provide insight and promote discussion.
"The small class allowed for great class discussion. Course Director was VERY KNOWLEDGEABLE on the topic. He was able to address all questions." Karen W., Senior Scientific Compliance Scientist, AbbVie
"This is one of the best courses I have ever taken. The Course Director was very clear and straight to the point. The content was up to date and full of real-life examples!" Marilia B., Compliance & Training Manager, Roche Brazil
"Although some of the material was a review for me, I felt it was presented very well. The instructor kept the course interesting through discussions and interactions with attendees." John V., Clinical Program Manager, Sorin Group
"The Course Director gave many practical, real life examples on dealing with and detecting fraud and misconduct. He was very knowledgeable and engaging." John D., Quality Assurance Auditor, Johnson & Johnson
Fraud or misconduct is defined as the collection, submission or use of data or information that falsely represents what happened during a study. Misconduct can include errors of omission (leaving out data) or errors of commission (intentionally using false data).
The purpose of this course is to learn some of the best practices for ensuring compliance and conducting an audit. There is much more to conducting an audit than taking a course. The goal of this course is to provide the fundamentals background one needs to become an auditor.
Over the years, the most common inspection findings from FDA still relate to not following the protocol, protocol deviations, and subject protection issues for sites and inadequate oversight (monitoring) and follow-up on issues identified for sponsors/CROs.
Monitoring is the ongoing process of overseeing a study to ensure patient safety, data quality, protocol compliance, and regulatory compliance. Auditing on the other hand are the processes we use to assure that study procedures and processes have been followed, and to verify that all aspects of the study were conducted according to the protocol. Monitoring can be thought of as quality control, while auditing is quality assurance.
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