Take advantage of our $1507.50 price by registering early!
* After Friday, December 27, 2019, costs are $1687.50.
investigator noncompliance in the research industry is critical to successful
clinical trials. Regulatory authorities expect that all stakeholders identify
noncompliance, correct the noncompliance through intervention, and evaluate the
effectiveness of the intervention. Root cause analysis provides a process
through which issues can be accurately identified and interventions can be
effectively designed. The corrective action process including, when
appropriate, preventive action planning, should be implemented when RCA has
been completed. An effective CAPA process can lead to improved human subject
protections and confidence in the integrity of the data. Lack of effective
corrective action management can lead to repeated noncompliance, compromised
subject safety, poor data quality, and/ or unacceptable inspection findings
with subsequent negative impact on the final submission. This course focuses
specifically on the management of noncompliance issues occurring at investigative
- Define investigator and site noncompliance
- Describe performance management
concepts and skills for effective site risk management
- Integrate prevention of performance
issues and ensure adequate site issues management
- Implement Gilbert’s Behavioral
Engineering Model for a diagnostic root cause analysis process
- Apply performance management
concepts in case studies with a focus on prevention and issues management
- Recognize components of effective
corrective action planning and documentation
- Identify examples of corrective
action planning for different site noncompliance case scenarios
- Discuss successful preventive action
planning and implementation
- Clinical Research Associates, Project Managers
and Clinical Research Associate Managers
- Principal Investigators, Site
Research Directors and Coordinators
- Quality Assurance Staff
The course will be led by one of the following
Hoelle, R.N., B.S.N., C.C.R.A.-PM., P.M.P.
Lily Romero, P.A., C.C.R.C.
Click here for complete trainer
Day One: 8:30 a.m. – 5:00 p.m.
- Defining Investigator Noncompliance: Regulatory definitions and categories
- Performance Management Concepts: Theories of motivation, taking a risk-based approach to
monitoring, issues escalation and management
- Root Cause Analysis: Detailed examination of Gilbert’s Behavioral Engineering
Model and its application to root cause analysis
- Application of Root Cause Analysis Concepts: Behavioral interviewing, the 5 Why’s, and open-ended
Two: 8:30 a.m. – 5:00 p.m.
- Application of Performance Management Concepts: 7 Comprehensive compliance management steps
- Corrective and Preventive Action Plans (CAPA) – Concepts and
Examples: Problem solving and implementing both short-term corrective
and long-term preventive actions
- Documenting Investigator Noncompliance: Linking noncompliance to regulatory requirements;
documentation best practices
- Exercises in Concept Application: Review and critique of simulated monitoring reports documenting
noncompliance and CAPA
- Individual case studies (based on actual FDA
warning letters) are assigned to each participant to practice and apply
- Identification of noncompliance and
Questions to ask to determine the root cause
- Identification of necessary
corrective and preventive actions
- Identification of necessary
- Documenting the issue in monitoring
reports and correspondence
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 (1.5 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#: 0778-0000-19-060-L01-P.
this course at your company! For more information, contact Naila Ganatra at +1