FREE: Subscribe to EYE-Zine Today and Receive "TIPS for A Productive Office"
Name
Email

Ophthalmic Research Training
9050 Summerfield Rd
Temperance, MI 48182

Telephone: (419) 343-7384



Audit Preparation Survival & Success - Never Be Surprised Again!

Ophthalmic Research Training Services - Clinical Research Training
Clinical research success starts at the beginning of the project. But often the audit process can occur mid or late term project, after issues have already occurred. Learn the techniques and tools that will help you not only survive an audit but emerge with flying colors!

Ophthalmic Research Training Services has been involved with many audits and has researched this process for you and will share with you the inside tips on what auditors look for.

Regardless if you've never been through the audit process or if you're a seasoned participant this training is for you.

Recent FDA guidance suggests a shift in views of the Principal Investigators responsibility including delegation and monitoring issues that are identified during audit processes which will be addressed in the seminar.

This seminar will provide the tools for proper organization and audit readiness as well as provide insider information and tips on handling an audit at your site.

Templates and tools are included in the class material designed to help you start preparing the right way for any audit.

What You Will Learn

In this training seminar you will learn:
  • Prior, Proper, Planning - Guidelines to being audit ready - all the time

  • Action Item Checklist - how to use this tool to your advantage

  • Audit Prep Checklist- How this tool will support your research efforts

  • Evaluate your monitors and the potential impact they could have during an audit

  • Outline the key points that would make a audit inevitable

  • Learn what information must be available to auditors

  • Templates for tracking the study activities

  • Understand the elements of the Quality Assurance Audit

  • Understand when and why a FDA audit occurs
Who Should Attend
  • Principal Investigators

  • Clinical Research Coordinators

  • Research Administrators

  • Research Personnel directly involved with a potential audit
Length of Seminar

This seminar is a full 8-hour training session.

Location of Seminar

This seminar is held at our Training Facility in Dundee, MI.

Or, it can be held in your office or any city in the country.

Please contact us at 419-343-7384 for more information.