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FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program

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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.

Speaker
Instructor: Charles H Pierce
Product ID: 701895

Course "FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

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:

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:

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.

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Refund Policy
"Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
For substitution, please email editor@complianceonline.com or call +1-650-620-3937.

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Training Options Training Duration = 60 Min
$299.00 Access Recorded Version Only
One Person - Unlimited viewing for 6 Months
(For multiple licenses contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
$449.00 Get Training CD Only
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days