The
online 10-Week Clinical Research Auditing Certification Program provides a
comprehensive introduction to clinical research and the job function of the Clinical
Quality Assurance Auditor for drug, biologic, and device trials. This program
is geared toward individuals seeking a new career or transitioning into Good
Clinical Practice (GCP) auditing. Case studies and industry best practices are
presented to emphasize how the learning objectives apply directly to the
responsibilities of the GCP auditor.
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.
- Describe and discuss the investigational product
development process, including FDA regulations, ICH guidelines, and Good
Clinical Practices (GCPs)
- Explain the roles and
responsibilities of a Clinical Quality Assurance Auditor
- Describe the types of audits,
including the responsibilities of the auditor in preparation, activities,
and follow-up
- Examine and apply the FDA’s methods
for inspections of Clinical Investigators, IRBs, sponsors/CROs
- Discuss regulatory compliance and
quality assurance issues and documentation
- Module 1: Investigational Product Development,
the FDA, and Good Clinical Practice Guidelines
- Module 2: Auditing as a Profession
and Compliance Tool
- Module 3: The Types of Clinical
Research Audits and Preparation
- Module 4: Quality Systems for
Auditing
- Module 5: Risk-Based Auditing and
Developing Risk-Based Auditing Plans
- Module 6: The Auditing Process:
Clinical Investigator
- Module 7: The Auditing Process:
Institutional Review Board/Ethics Committee
- Module 8: The Auditing Process:
Sponsor/CRO
- Module 9: Gathering and
Disseminating Information: Verbal and Written Communication
- Module 10: Regulatory
Classification and Communication: Recent Inspection Findings
- Clinical Quality and Compliance Professionals
- New or Aspiring Auditors
- Clinical Research Associates
- Project Managers
- Medical Monitors
- Regulatory Affairs Professionals
- Clinical Research Coordinators
- Clinical Principal Investigators
- IRB Administrators and Members
NOTE: This course is for
individual registrants only and does not allow for group training.
What participants say about Barnett's 10-Week courses
...
“Great course! Instruction is expertly led and engaging. I
will recommend Barnett to any colleague and will seek out topics for my own
future training and professional development needs.”
"The course has been so incredibly helpful thus far...I
look forward to Thursday evenings!"
“This class exceeded my expectations of an online learning
experience. The instructor was knowledgeable, came equipped with great examples
to keep the class interesting and is a strong presenter. Thank you!”
Elizabeth
Ronk Nelson, M.P.H.
Click here for complete trainer
biographies
10 weeks for 3 hours each week.
$1,795 by Early Bird Deadline
$1,995 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.
Barnett International is
accredited by the Accreditation Council for Pharmacy Education as a provider of
continuing pharmacy education. Participants will receive 30 hours
(3.0 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#:
0778-0000-20-063-L04-P. Released: 8/20.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.