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
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.