30-Hour Clinical Research Auditing Certification Program
This hands-on clinical research auditing course provides a step-by-step approach to the job responsibilities of the Clinical Quality Assurance Auditor for drug, biologic, and device clinical trials. Case studies and industry examples requiring active learner engagement are presented to emphasize the types of audits, quality systems and risk-based techniques for auditing and how to apply concepts directly. The course covers a range of auditing techniques that are grounded in the alignment with regulatory requirements and the expectations of regulatory inspectors.
OVER THE PAST 10 YEARS . . .
Donna W. Dorozinsky, R.N., M.S.N., C.C.R.C.
Ms. Dorozinsky has over 25 years of experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management. She spent 15 years at SmithKline Beecham in early development and in 2005 founded DWD & Associates, Inc., which has most recently became Just in Time GCP. She has led the implementation of eSource and Electronic Trial Master File solutions, and has expertise in clinical validation of these systems. She recently served as chair of the revisions to Zone 4 of the TMF Reference Model. Donna has presented numerous training programs in topics of GCP compliance, Quality Management Systems, and TMF Management and is a dynamic educator. Donna is also the Editor-in-Chief of Barnett’s Good Clinical Practice: A Question & Answer Reference Guide.
Frequently Asked Questions
Can I obtain CEU by attending a Barnett course?
Program participants will receive continuing education units (CEUs) as indicated on each course description page for full participation (complete sign-in sheet, pre- and post-test, and evaluation form). Barnett must receive all completed documentation within 30 days of program completion or CEUs will not be issued. Barnett International will issue a receipt of completion
What is an Interactive web seminar?
Barnett International teams with WebEx™ meeting services to provide you with Interactive Web Seminars. Ask questions, chat, learn from industry leaders, and network with your fellow attendees all from the convenience of your own office. No travel, no travel expenses, and no time away from the office! The resources required are already at your fingertips – an Internet connection and a phone.
How does the training portal subscription work?
Once you decide on the registration approach you will take, Barnett will provide a spreadsheet containing all available courses. Select the courses you would like included in your subscription and return the spreadsheet to Barnett. Upon receipt of your course selections, you will receive your login credentials to Barnett’s Learning Management System (LMS) within three business days.
Since 1979, Barnett International has set the standard as leaders in clinical research training for:
Excellence Through Continuous Learning
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