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 prevent surprises when being audited. You will learn to identify risks and handle them to build a more compliant and successful trial. This program will also cover the ”audit experience”, by sharing what auditors look for and how to prepare for the visit. We will discuss how you can define expectations, train your staff and hold them accountable and make the inspection process easy to manage. This webinar will describe proactive measures you can take to assure that all systems are in place, operating well and operating in compliance.
Areas Covered in the Seminar:
- QA Program factors- implementing a program in place.
- What are the risks?
- What a sponsor and investigator need to know about FDA audit.
- What is reviewed at the audit.
- Tips for a successful study.
- Preparing for a site visit.
- Most common FDA violations/actions.
For More Details:
NOTE : Use this Promocode (128600) to avail 10% discount, valid upto 16th November 2011