As
scrutiny of sponsors, Contract Research Organizations (CROs), and monitors
involved in the conduct of clinical research intensifies, companies are using
their quality assurance resources to review internal (and vendor) systems to
ensure compliance within a changing regulatory environment. A systematic application
of the Compliance Program Guidance Manual (CPGM) permits identification of
regulatory risks during qualification and in-process audits. This web seminar
will review the FDA’s current guideline for conducting inspections and how to
apply them to assess Quality Systems. Assessment of the SOPs that are expected
for sponsors and CROs, including registration of trials and informed consent
document issues, will also be discussed.
- Integrate new regulatory requirements and
processes into audits
- Translate inspection criteria to
Quality Systems that support changes in inspection focus
- Assess the FDA’s application of the
CPGM as reflected in regulatory communication
- Examine steps for preparation of an
inspection
- Professionals from Academia whose institutions or
investigators hold INDs or IDEs, or whose institutions support clinical
research with Site Management Organizations (SMOs)
- Clinical Quality Assurance Auditors
- Clinical Quality and Compliance
Professionals
- Clinical Research Associates
- Project Managers
- Medical Monitors
- Regulatory Affairs Professionals
- Clinical Research Coordinators
Elizabeth
Ronk Nelson, M.P.H.
Click here for complete trainer
biographies
$735
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.
Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com
Barnett International is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. Participants will
receive 2 hours (0.2 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#: 0778-0000-18-010-L01-P.
Released: 1/18.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.
