Why Should You Attend:
There is an increasing frequency of real-time FDA Audits of trials and it seems that no one is well prepared. It is reasonable to expect that the Sponsor’s Monitors would be invaluable to the Site, CRO and even the Sponsor themselves to find errors and mistakes and correct as well as prevent their future occurrence.
The main principle is to follow exactly the signed and approved (IRB + PI) Protocol to the letter. In the current regulatory climate, GCP Investigator site audits are a part of the clinical trail process. Sponsors should anticipate more inspections and information requests regarding monitoring practices. Many monitoring systems lack components that ensure proper management of the research site. This webinar will present the components of a quality monitoring system so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections.
This training will provide an in-depth understanding of FDA regulations and the ICH GCP recommendations in this regard. It will ensure that you know and follow the research plan (Protocol) exactly as it is written.
Areas Covered in the Seminar:
- What does the FDA look at when Auditing/Inspecting a study?
- The Sponsor‘s responsibility in monitoring study conduct.
- Components of a sponsor monitoring system beyond SOPs.
- The nature of adequate oversight of all staff and non-staff.
- The importance of Protocol knowledge in preventing errors.
- How do sites prepare for an audit / inspection.
- The measures to ensure quality monitoring..
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