Take advantage of our $1675.00 price by registering early!
* After Friday, May 4, 2018, costs are $1875.00.
future of clinical trial conduct demands a Quality System approach. Recently,
regulators have been recommending that a quality system approach be used 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 is an
integral component of a quality system approach, and many researchers do not
have the knowledge or experience to conduct clinical trial risk management.
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 quality system
- Describe a quality system approach
as it pertains to trial conduct
- Apply the concepts of a risk
management approach and how they relate to a quality system approach
- Describe how corrective and
preventive action (CAPA) and root cause analysis (RCA) pertain to a
quality system approach
- Define and demonstrate the
application of quality system approach tools to study conduct
- Clinical Quality Assurance Professionals
- 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)
- Fitting Clinical into the QMS
- Developing a QMS Quality Manual Group Exercise
- Principals of 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
- 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