FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitori (Clinical Compliance )
Venue: Online Event
|Event Date/Time: Dec 16, 2011||End Date/Time: Dec 16, 2011|
Areas Covered in the Seminar:
- What does the FDA look at when -Auditing/Inspecting a study?
- The Sponsorâ€˜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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