This FDA Clinical Trial Auditing training will cover the FDA regulations and the ICH GCP recommendations to ensure your site is prepared for a clinical trial audit.
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"This course is certified by Regulatory Affairs Professional Society (RAPS). Attendees of Live Webinar are eligible for 1 RAC Points up on full
completion of the course."
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Why Should You Attend:
There is an increasing frequency of real-time FDA Audits of trials and it seems that no one is well prepared. It is reasonable to expect that the Sponsor’s Monitors would be invaluable to the Site, CRO and even the Sponsor themselves to find errors and mistakes and correct as well as prevent their future occurrence.
The main principle is to follow exactly the signed and approved (IRB + PI) Protocol to the letter. In the current regulatory climate, GCP Investigator site audits are a part of the clinical trail 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. This webinar will present the components of a quality monitoring system so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections.
This training will provide an in-depth understanding of FDA regulations and the ICH GCP recommendations in this regard. It will ensure that you know and follow the research plan (Protocol) exactly as it is written.
Areas Covered in the Seminar:
- What does the FDA look at when Auditing/Inspecting a study?
- The Sponsor‘s responsibility in monitoring study conduct.
- Components of a sponsor monitoring system beyond SOPs.
- 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.
- The measures to ensure quality monitoring..
Who Will Benefit:
This Webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be:
- Holders of the IND for new products
- 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
- Study Monitors
- Clinical Research Data managers
Instructor Profile:
Charles H. Pierce, MD, PhD, FCP, CPI Has 20+ years experience in bringing the message (via 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.
