This
course provides a comprehensive review of Good Clinical Practice (GCP) and FDA
regulations and requirements. Participants receive a foundation of knowledge
about GCP, practical examples, and the underlying scientific and regulatory
principles involved. Guidelines for each aspect of research are provided, as
well as information on the structuring and preparation of protocols, consent
forms, and investigator brochure. Information on maintaining an ongoing
relationship with the FDA will also be discussed. This course enables clinical
professionals to prepare concise documents and provide their company and the
FDA with necessary information for their clinical studies. The R2 changes are covered in this course.
- Summarize Good Clinical Practice (GCP) Clinical
Research Team Roles and Responsibilities
- Recognize how GCP impacts the
clinical research process through review of key documents and necessary
information for clinical trials
- Apply concepts of root cause
analysis and corrective and preventive actions for quality management
- Discuss key elements for monitoring
reports and written documentation in GCP
- Review regulatory compliance, audit
preparation and inspections
- This course is intended for Clinical, Regulatory,
and Quality Personnel who require an understanding of the GCP regulations
and requirements. This course will also benefit other personnel who must
be familiar with the essentials of the clinical process and requirements.
The course will be led by one of the following
instructors:
Gary B. Freeman, M.S.
Marla Hoelle, R.N., B.S.N.,
C.C.R.A.-PM., P.M.P.
Angie Maurer, R.N., B.S.N., M.B.A.
Lily Romero, P.A. C.C.R.C.
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biographies
Day One: 8:30 a.m. – 5:00 p.m.
- Introduction to ICH and FDA GCPs: History; law; regulations; definitions; FDA organization;
bioresearch monitoring group; evolution of GCP; ICH process
- Clinical Research Team Roles and Responsibilities: Sponsor, Investigator and IRB responsibility
- Informed Consent and Essential Documents: Elements of the Informed Consent, Essential
Documentation Responsibilities of Sponsor and Investigator
Day
Two: 8:30 a.m. – 5:00 p.m.
- Root Cause Analysis & Corrective and Preventive Actions for
Quality Management
- Compliance, Audits, Inspections & Conclusions
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
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#: 0778-0000-19-036-L01-P.
Released: 9/19.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.