GCP violations and Site Mistakes commonly found During a FDA Investigator Site Inspection/Audit and how to avoid them

This GCP training will guide you through key component identification of a good GCP audit program, Investigator awareness, Protocol adherence, The Informed Consent process, Evaluation of subject selection, Inclusion/exclusion criteria, data sampling and audit findings assessments.

Why Should You Attend:

All CRO’s, Sites, and Sponsors of Clinical Research involved in the drug and device development process have an interest in being prepared for an audit. The main principle is to follow exactly the signed and approved (IRB + PI) protocol to the letter. This, in fact, is included on the FDA Form 1572. In the current regulatory climate, GCP Investigator site audits are a part of the clinical trial process. Sponsors should anticipate more inspections and information requests regarding monitoring practices. Many monitoring systems lack components that ensure proper management of the research site. All sites conducting Clinical Research should know how to ensure control of investigational product, data integrity, oversight of investigators as well as other areas.

Attending this webinar is a good step toward learning the FDA processes and why a knowledgeable PI is so important. The components of a quality in-house monitoring system will be presented so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections.

It will be important to see what the FDA regulations and the ICH GCP recommendations are in this regard. The key is that the PI and all clinical staff know and follow the research plan (Protocol) exactly as it is written. This webinar will review FDA inspection program details and how to ensure your site is prepared for an inspection. It will help you to avoid the common GCP mistakes and enhance the overall audit experience.

Areas Covered in the Webinar:

• What does the FDA look at when auditing/inspecting a study?
• The regulatory requirements for the BIMO program
• Studies targeted for auditing and what does the Inspector/Auditor look for?
• What are the common GCP mistakes sites make?
• The nature of adequate oversight of all staff and non-staff
• The importance of protocol knowledge in preventing errors
• How do sites prepare for an audit / inspection
• What happens after an inspection / audit is done?

Who Will Benefit:

This Webinar will provide invaluable assistance to all personnel in the pharmaceutical, biotechnology, and CRO industry conducting clinical trials including:

• Sponsor Senior Management
• Project Managers
• CRA Managers
• QA/Compliance Personnel
• Principal Investigators and Sub Investigators
• Clinical Research Scientists (PKs, Biostatisticians)
• Safety Nurses
• Clinical Research Associates (CRAs) and Coordinators (CRCs)
• Recruiting Staff
• QA / QC Auditors and Staff
• Clinical Research Data Managers

Instructor Profile:

Charles H. Pierce, MD, PhD, FCP, CPI has 20+ years’ experience in the Clinical Research field. He now brings the message (via publications, webinars, lectures and seminars) of risk management through knowledge of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. He has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator and staff GCP training, and medical monitoring in both drug and device studies.