This
web seminar is designed for participants that are sponsors/CROs and research
site representatives preparing for a research site FDA inspection. From audit
readiness to action item resolution, each site faces its own unique challenges.
This course will prepare you and your site for expectations from the FDA and
provide concrete steps you can take to prepare before, during and after the
inspection.
- Recognize the anatomy of an audit: The foundation
of preparation, the regulations and ICH, types and focus of FDA audits
- Review the dynamics of audit
readiness: Starting at site selection, preparing sites with large
deficiencies
- Discuss the mission of the FDA BIMO
Program revisions
- Recognize the timing of an FDA
audit: Audit readiness, action item resolution, follow up after the audit
- Identify mechanics of the audit:
Start to finish
- Project Managers
- Clinical Research Associates
- Site Managers
- Research Site Personnel
The course will be led by one of the following
instructors:
Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.
Jeanne Morris, B.S., MT
(ASCP)
Click here for complete trainer
biographies
$625
Includes up to 20
participants at one site. All participants (up to 20) are eligible for
“Certificates of Attendance,” and accreditation, provided that accreditation
requirements are met. For groups larger than 20 or for additional sites, please
call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Barnett International is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. Participants will
receive 2.5 hours (0.25 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#: 0778-0000-17-044-L01-P.
Released: 6/17.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.