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MentorHealth to organize webinar on “FDA Clinical Trial Auditing and the Due Diligence Companies Sho

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(Free Press Release) Charles H. Pierce, a consultant in the Clinical Research/Drug-Device Development arena will be the speaker at a webinar that MentorHealth, a leading provider of online training for the healthcare industry, is organizing on November 5. This webinar is on the topic, “FDA Clinical Trial Auditing and the Due Diligence Companies Should Conduct as Part of their Monitoring Program”.

MentorHealth to organize webinar on “FDA Clinical Trial Auditing and the Due Diligence Companies Sho


      

Summary: Charles H. Pierce, a consultant in the Clinical Research/Drug-Device Development arena will be the speaker at a webinar that MentorHealth, a leading provider of online training for the healthcare industry, is organizing on November 5. This webinar is on the topic, “FDA Clinical Trial Auditing and the Due Diligence Companies Should Conduct as Part of their Monitoring Program”.

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Description:

This webinar is about the due diligence that companies conducting FDA clinical trial auditing should imbibe as part of their monitoring program.

All CRO's, Sites, and Sponsors of Clinical Research –in other words, everyone involved in the drug and device development process – needs to be well-prepared for the audit process. The audit goes topsy-turvy when there is knowledge gap on the part of any one cog in this wheel.  This webinar will give participants a proper and thorough learning of the FDA processes and drives home the importance of the Sponsor's/CRO's Monitors.

The core principle is to adhere, in the strictest possible terms, to the signed and approved (IRB + PI) Protocol relating to this matter. This is spelt out in the FDA Form 1572. The current regulatory practice makes GCP Investigator site audits a part of the clinical trial process. As a result, Sponsors should anticipate more inspections and information requests regarding monitoring practices. However, many monitoring systems lack components that ensure proper management of the research site.

Monitoring systems should include specific components to ensure control of investigational product, data integrity, and oversight of investigators as well as other areas. This webinar presents the components of a quality monitoring system that participants can use to assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections.

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When: November 5, 10:00 AM PDT | 01:00 PM EDT

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By whom:

Charles H. Pierce, MD, PhD, FCP, CPI is a consultant in the Clinical Research/Drug-Device Development arena specializing in bringing the message 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.

Dr. Pierce serves as an advisor to several clinical research organizations, sits on industry based boards, and is VP of Medical Affairs for Harrison Clinical Research GmbH, a global CRO headquartered in Munich.

He has been in the Clinical Research Industry for 20 years, and 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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For whom:

The webinar will benefit

o Senior Management

o Project Managers

o CRA Managers

o QA/Compliance persons

o Principal Investigators and sub investigators

o Clinical Research Scientists (PKs, Biostatisticians, ...)

o Safety Nurses

o Clinical Research Associates (CRAs) and Coordinators (CRCs)

o Recruiting staff

o QA / QC auditors and staff

o Clinical Research Data managers

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Duration: 60 minutes

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To enroll for this webinar, contact

This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Ph: 800-385-1607

Fax: 302-288-6884

http://bit.ly/1eLU46x

 

 

 




MentorHealth to organize webinar on “FDA Clinical Trial Auditing and the Due Diligence Companies Sho

Source: Press Release

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