Take advantage of our $1675.00 price by registering early!
* After Friday, August 31, 2018, costs are $1875.00.
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.
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.
- 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
- GCP Clinical Quality Assurance Professionals
- Sponsor and Vendor Clinical Operations Personnel
- Investigators and Sub-Investigators
- Study Coordinators
- Study Monitors
- Project Managers
The course will be led by one of the following instructors:
Truax-Bellows, M.S., FNP, C.C.R.A., RQAP-GCP
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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
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
- Group Breakout Exercises
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
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.
this course at your company! For more information, contact Naila Ganatra at +1