The Future of Good Clinical Practice Demands a Quality System Approach: Will You be Ready?

EARLY REGISTRATION
Course #: SQSF0818
August 14-15, 2018 | San Francisco, CA
8:30 AM - 5:00 PM Eastern
Hilton San Francisco Union Square
Take advantage of our $1675.00 price by registering early!
* After Friday, July 13, 2018, costs are $1875.00.
*
$1,675.00

Take advantage of our $1675.00 price by registering early!
* After Friday, July 13, 2018, costs are $1875.00.

Course Description

The future of Good Clinical Practice (GCP) for the conduct of clinical trials demands a Quality System approach. With the advent of ICH E6 R2 and its subsequent adoption by several countries and many sponsors and clinical investigators, a quality system approach is necessary for the design, development, and execution of clinical studies.

FDA guidances speak on the need to conduct clinical trials using such an approach, but provide little in the way of direction on how to accomplish this. Risk management along with the application of corrective and preventive actions (CAPA) when issues arise, has become an integral component of GCP quality system approach. Many researchers do not have the knowledge or experience to conduct clinical trial risk management and adequately execute CAPA. This course will apply practical approaches and demonstrate associated tools and skills to assist the participant in using a quality system approach within the clinical trial arena from both the site and sponsor perspective.

Learning Objectives

  • Identify regulatory body/authority recommendations for a GCP quality system
  • Describe a quality system approach as it pertains to trial conduct
  • Apply the concepts of a risk management approach to GCP and how they relate to a quality system approach
  • Describe how corrective and preventive action (CAPA) and root cause analysis (RCA) pertain to a GCP quality system approach
  • Define and demonstrate the application of GCP quality system approach tools to study conduct

Who Should Attend

  • GCP Clinical Quality Assurance Professionals
  • Sponsor and Vendor Clinical Operations Personnel
  • Investigators and Sub-Investigators
  • Study Coordinators
  • Study Monitors
  • Project Managers

Instructor

The course will be led by one of the following instructors:

Lee Truax-Bellows, M.S., FNP, C.C.R.A., RQAP-GCP

Click here for complete trainer biographies

Course Outline

Day One: 8:30 a.m. – 5:00 p.m.

  • Principals of Quality Management System (QMS) in a GCP setting
  • Fitting Clinical into the QMS  
  • Developing a QMS Quality Manual Group Exercise  
  • Principals of GCP Risk Management  
  • Risk Management Group Exercise  

Day Two: 8:30 a.m. – 5:00 p.m.

  • Recap Day One
  • Principals of RCA  
  • RCA Group Exercise  
  • Principals of a CAPA Program  
  •  GCP CAPA Group Exercise
  • Questions and Answers

Interactive Activities

  • Group Breakout Exercises
  • Q&A

Registration Fees

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.  

Click here for our seminar cancellation policy

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-18-008-L01-P. Released: 2/18.

 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.