Course Description
Are you prepared for Quality Risk Management (QRM), Risk Management (RM), Risk-Based Quality Management (RBQM)? With ICH GCP E6 R2 now requiring risk-based approaches to managing quality in clinical trials, this 10-Week series takes you through, step-by-step, how to execute these requirements. We will focus on the critical elements for clinical trial sponsors and CROs included in the ICH GCP E6 R2 expectations, while highlighting key points from other regulatory bodies such as ISO 31000 Risk Management. Each step of risk identification, assessment, control, review, reporting, management, and communication are also reviewed.
The resources required to take this on-line course are already at your fingertips - an Internet connection and a phone. After registering, you will receive an email confirmation that provides you with the Web Seminar link and audio connection information.
Prior to the start of the course, participants will receive Module 1 materials. Course materials for subsequent modules will be sent weekly prior to class. Come to class prepared to interact – you will be able to ask questions, provide feedback and participate in discussions and group work. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.
Learning Objectives
Course Outline
Who Should Attend
NOTE: This course is for individual registrants only and does not allow for group training.
What previous students have said ...
“This course is beyond my expectation with very practical examples and tools. Both instructors are excellent with great attention to address participants’ questions.”
"The course was well designed. These lessons were valuable in seeing the big picture of clinical research."
“The tools provided were great. I hope to use the risk log and risk analysis tools.”
Instructor
The course will be led by one of the following instructors:
Susan M. Leister, M.B.A., Ph.D., CQA, CSSBB
Shelia Russell McCullers, M.S., D.M.
Click here for complete trainer biographies
Course Length and Time
10 weeks for 2 hours each week.
Registration Fees
$1,695 by Early Bird Deadline
$1,895 after Early Bird Deadline
This course is for individual registrants only and does not allow for group training.
All participants are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met.
Accreditation Information
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 20 hours (2.0 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-23-005-L99-P. Released: 4/23.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.