World Conference Calendar

33842 Conferences

Fundamentals of FDA

Added by davidross759 on 2010-10-06

Conference Dates:

Start Date Start Date: 2010-10-20
Last Date Last Day: 2010-10-20

Conference Contact Info:

Contact Person Contact Person: Webinars
Email Email: webinars@globalcompliancepanel.com
Address Address: Online Training Webinar, Wilmington, DE, 19801, United States
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference Description:

This webinar will provide help both sponsor companies (pharmaceutical, biotech, device/diagnostics), and clinical sites utilize quality improvement methods and effectively prepare for upcoming GCP inspections.

Why should you attend: Oftentimes, GCP inspections, particularly from FDA investigators, can be seen as an intimidating and adversarial experience as opposed to a process used to improve quality and ensure compliance. Overall, inspections are an important part of the GCP process that helps prove that the final study product is safe and effective for consumer use. This webinar will provide help both sponsor companies (pharmaceutical, biotech, device/diagnostics) and clinical sites utilize quality improvement methods and effectively prepare for upcoming GCP inspections.

Areas Covered in the Session:

* Most common FDA inspection deficiencies noted among sites and sponsors
* Overview of GCP regulations and FDA guidelines used for inspections
* Strategies used in FDAs Inspection planning
* What areas are reviewed during GCP inspections
* Inspection documentation and proper follow-up procedures
* Effective techniques and tools to use in Preparing for GCP Inspections

Who Will Benefit:This webinar will provide valuable information to personnel in Sponsor Companies (i.e., Pharmaceutical, Biotechnology, Medical Device, etc.) as well as CROs and investigator sites conducting clinical trials including:

* Clinical Research Associates
* Compliance/GCP Quality Assurance staff
* Study Managers
* Site Staff/ Study Coordinators
* Clinical Investigators
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