In this Clinical Trial Audits training learn the risk management and best practices of GCP audit by reviewing and analyzing recent GCP audit finding from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs).

1. Assessing GCP Compliance in Clinical Trial Audits- Risk management
and Best practices
December 03, Friday 10:00 AM PST | 01:00 PM EST
Why Should You Attend:
Quality assurance is defined as a “systematic and independent examination of trial-related activities and documents” that
allows an auditor to determine whether or not the clinical trial was conducted according to the regulations and guidance
that govern clinical research. This course will provide an overview of auditing skills and techniques and a review of recent
GCP audit findings from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs).
Date: December 03, Friday 2010
Time: 10:00 AM PST | 01:00 PM EST
Duration: 60 Min
Instructor: Sandy Rizk Soliman
Location: Your office or conference room (no need to travel!)
Why Should You Attend:
• Overview of the main ethical principles to be considered in the development and conduct of research to protect
• Discuss how QA differs from QC and who is responsible for each.
• Determine who gets audited and factors and metrics for assessing when or why to audit.
• Discuss guidelines on how the FDA trains its investigators to audit.
o Clinical Investigators (Sites)
o Sponsors
o Institutional Review Boards (IRBs)
• Review recent noncompliance trends and regulatory focus for Sites, Sponsors, and IRBs.
Sandy Rizk Soliman
Register Now

2. Who Will Benefit:
This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, CROs and Research
Facilities Conducting Clinical Trials including:
• Clinical Quality Assurance Auditors
• Clinical Quality and Compliance Professionals
• Clinical Research Associates (CRAs)
• Project Managers
• Medical Monitors
• Regulatory Affairs Professionals
• Clinical Research Coordinators (CRCs)
• Clinical Investigators (PIs)
• IRB Administrators and Members
Instructor Profile:
Sandy Rizk Soliman, Co-founder and Chief Executive Officer of Research Alliance LLC.; a consulting firm
focused on global clinical trial solutions, tools, and training to streamline drug development to market. The
firm advises clinical research sites, pharmaceutical drug development, biotech, medical device, and con-
tract support organizations. Sandy began her journey in Clinical Research over 13 years ago. Her experi-
ence spans key aspects in multiple therapeutic areas and phases of drug development in the roles of study
coordinator, site monitor, clinical research project manager, and trainer. She has effectively provided clinical
research education and customized training in areas of the clinical research process, the FDA regulations,
GCP (Good Clinical Practice) and the International Conference of Harmonization (ICH) guidelines.
Registration Information:
* Register Online. Use your American Express, Visa or MasterCard.
* For more than one attendee get 20% off on the price of additional attendee.
* Get your group to attend the webinar at a discounted price call +1- 650-620-3937.
* Call +1 - 650-620-3937 or Fax your PO: 650-963-2556.
* Mail your check to: ComplianceOnline (MetricStream, Inc), 2600 E. Bayshore Road, Palo Alto, CA 94303.
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