The Sponsor’s Role in Preparing a Site for an FDA Audit

Website http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500991?expDate=Sep4_2015_FDA-Insp | Edit Freely

Category Study Sponsor responsibility, Clinical Research, Clinical Study Monitoring, Investigators Brochure, IRB/IEC responsibility in Clinical Research, Investigator Responsibility in Study Conduct, Data Management, Drug Development, Pharmaceutical Industry, Good Clinical Practice (GCP), International Conference on Harmonization (ICH), Principal Investigator, Study Monitoring

Deadline: September 03, 2015 | Date: September 04, 2015

Venue/Country: online Webinar, U.S.A

Updated: 2015-08-25 21:07:39 (GMT+9)

Call For Papers - CFP

Instructor: Dr Charles H Pierce

Product ID: 500991

Description

This webinar will review FDA inspection program details and how to ensure your sites are prepared for an inspection. The adage of Forewarned is Forearmed clearly applies. Focus areas would be how you assure Investigator involvement, site protocol adherence, and appropriate methods for data sampling.

The Sponsor of a clinical research study has a significant responsibility in the Drug Development Process. This starts with preparing a complete Investigators' Brochure and from this information preparing the study protocol to be safe and to provide effective data. At this point they are then responsible for choosing sites and Principal Investigators who will conduct the study following both the GCP of clinical research and the Federal regulations. To assure an error free conduct they are then responsible for monitoring the study to ensure data validity and integrity and for the reports to the regulatory authorities.

Areas Covered

The Sponsor's responsibility in ensuring quality monitoring of study conduct

Why Monitor Clinical Studies

What does a Sponsors Monitor look for?

How does a Sponsor or site prepare for an audit

To understand the importance of a well written protocol

What are the top 6 GCP problems found by monitors - plus several more

What are the main strategies to improve an audit outcome?

What does the FDA look at when auditing/inspecting a study?

What types of studies are targeted for auditing and what is looked for?

The Sponsors role in preparing a site for an audit

What are the common GCP mistakes sites make?

The nature of adequate oversight of all staff and non-staff

Why Should you Attend

GCP site audits are routine, increasingly seen, and a necessary part of the clinical trial process. If you are participating in a clinical trial or multiple trials as the Sponsor, Principal Investigator, study coordinator, monitor, or even as the IRB chances are that you may be involved in the audit process. This webinar will cover the most frequently found GCP violations / mistakes that are often found during the audit process. In addition, how to prevent audit findings you wish were not there.

For the sponsor to know the protocol and other GCP violations the FDA auditors find is great for prevention at your sites.

Objectives of the Presentation

Describe the main Sponsor responsibilities with regard to CR study conduct

Define at least four major mistakes found during an audit

List at least 3 strategies to improve audit outcome.

Discuss audit preparation tools identified in the webinar

Describe how to prevent each of the top audit findings to prevent a 483

Compare your experience in an Inspection with the examples given

Who can Benefit

This webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology, and CRO industry who may be called upon to conduct Clinical Trials including: Sponsor Senior Management, Project Managers, CRA Managers, as well as QA/Compliance persons.

In CRO's and sites, those benefiting the most would be:

Principal Investigators and sub investigators

Safety Nurses

Clinical Research Associates (CRAs) and Coordinators (CRCs)

QA / QC auditors and staff

Clinical Research Data managers

For Registration-

http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500991?expDate=Sep4_2015_FDA-Inspection=Channel=ourglocal

Note : Use coupon code 1371 and get 10% off on Registration