GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

"Hear By David R. Dills, he is currently the Director of Regulatory Services at CROMSOURCE, an international contract research organization "

Preventing fraud should be a standard part of any compliance plan

Description

The session will provide an understanding and overview of GCP requirements and clinical quality assurance in detecting fraud and misconduct in clinical trials. Gain experience and learn more about detecting, correcting, and preventing clinical study misconduct and fraud at domestic and international clinical sites. The issue of fraud is again a focus within the clinical research industry. Although high-profile cases tend to periodically pique our interest, ensuring the integrity of data and the protection of participants during the conduct of clinical research is an ongoing process. Developing and incorporating systems for detecting and preventing fraud should be a standard part of any compliance plan. We will address this and much more.

Why should you attend:

•        Learn what tactics to use to prevent and detect fraud and misconduct in clinical trials
•        Learn the regulatory background of fraud and the criteria for characterizing misconduct as fraud
•        Explore strategies for dealing with common clinical trial monitoring issues and the key documentation required           as part of clinical trial project management
•        Identify common GCP deficiencies and reviewing potential roadblocks for non-compliance
•        Detecting, correcting, and preventing clinical study misconduct and fraud
•        Achieve compliance success by being prepared and understand the inspection process

Areas Covered

•        Learn the regulatory background of fraud and the criteria for characterizing misconduct as fraud
•        Define the basic requirements of Good Clinical Practices
•        Determine the appropriate responsibilities and oversight required of the sponsor, monitor, and investigators to           ensure a high level of quality in a clinical trial
•        Quality practices that are designed and implemented to guarantee compliant clinical trials
•        FDA GCP inspections and recent trends
•        Define, and differentiate between, fraud and misconduct / noncompliance
•        Develop an understanding of why and how fraud occurs
•        Examine methods for detecting and preventing fraud and misconduct
•        Explain the Sponsor / CRO, IRB, Clinical Investigator, and Study Staff role in detection and prevention 
•        Identify and establish methods to uncover and preclude fraud and misconduct in clinical trials
•        Develop trial guidelines and a framework which will easily identify any misconduct and which is capable of                 quickly addressing any issues that arise in order to avoid regulatory consequences
•        Enforcement Actions

Who will Benefit

All levels of Management for all departments and those who desire a better understanding, overview and / or refresh of GCP audits, recent FDA enforcement activities, and certainly uncovering any potential misconduct and fraud in clinical trials, including:

•        Clinical Quality Assurance Professionals
•        Clinical Research Associates
•        Project Managers
•        Clinical Investigators

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

David R. Dills

David R. Dills, is currently the Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations. He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products. David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific. He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and com

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