How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices

This 90-minute webinar will help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies
 
 
ComplianceOnline 2011
ComplianceOnline 2011
 
March 8, 2012 - PRLog -- Why Should You Attend:

To be able to achieve sustainability and to remain sustainable and competitive in global medical product markets, it is necessary to streamline regulatory compliance processes, in particular, the Good Clinical Practice (GCP) for clinical trials and studies and beyond. To establish and maintain GCP, it is critical to accurately define, document and implement “current, accurate, and complete” (CAC) requirements pursuant to the relevant and applicable laws and regulations, GCP requirements, and compliance in a systematic, integrative (SI) manner.

This webinar is intended to help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies, the requirements and compliance in a systematic, integrative (SI) manner, all of which are regulated by the United States Food and Drug Administration (FDA). At the end of this webinar, you will leave empowered with the knowledge of applicable FDA regulations and requirements.

Areas Covered in the Seminar:

- Current, accurate, and complete (CAC) review of FDA regulations including INDs and IDEs.
- Systematic and integrative (SI) analysis of regulations and law governing clinical trials and studies, requirements, and compliance.
- General information for clinical studies.
- Clinical investigators (CI).
- Institutional review boards (IRBs).
- Sponsors.
- Monitors.
- Contract research organizations (CROs).
- ICH-GCP guidelines.
- ISO 14155.
- Enforcement actions (case studies).

For Registration:
http://www.complianceonline.com/ecommerce/control/trainin...

# # #

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates.
End
Source:
Email:***@complianceonline.com Email Verified
Phone:650-620-3937
Zip:94303
Account Email Address Verified     Account Phone Number Verified     Disclaimer     Report Abuse
ComplianceOnline News
Trending
Daily News
Weekly News



Like PRLog?
9K2K1K
Click to Share