Clinical Trial Auditing - Identifying risks and building a more compliant and successful trial
Thursday, July 12, 2012 from 10:00 AM to 11:30 AM (PDT)
Palo Alto, CA
This Clinical trial auditing training will provide an understanding of how to conduct compliant and successful clinical trials by defining FDA clinical trial audit procedures, audit program, audit planning and audit preparation.
Why Should You Attend:
The field of GCP has rapidly evolved over the last few years and the requirements are getting tougher. Many companies find themselves unprepared for a clinical trial audit, either at a clinical site or their headquarters.
This course will help you to prepare early and help to prevent surprises when being audited. Learn to identify risks and handle them to build a more compliant and successful trial.
Areas Covered in the Seminar:
- What is clinical Audit?
- Audit Vs. Research.
- The Audit Cycle.
- Five stages of Clinical Audit.
- QA Program factors- implementing a program in place.
- What are the risks?
- What a sponsor and investigator need to know about FDA audit?
- Interactive case study to learn about audits.
- Tips for a successful study.
- Preparing for a site visit.
- Most common FDA violations/actions.
Who Will Benefit:
This webinar will provide valuable assistance to all companies/employees (research sites, Clinical research organization, pharmaceutical and biotech industries) that conduct clinical trials.
- Regulatory Affairs
- Clinical Trial staff and management
- Clinical Development
- Project Managers
- Drug Safety staff
For Registration :
When & Where
At ComplianceOnline, we are focused on :
- 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, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.