Netzealous LLC DBA - Compliance4All, Online
It will be important to see what the FDA regulations and the ICH GCP recommendations are in this regard. The key is that the PI and all clinical staff know and follow the research plan (Protocol) exactly as it is written. To do this is ethical research. To not follow the protocol and document study conduct carelessly is folly.
Why should you Attend:
All CRO's, Sites, and Sponsors of Clinical Research involved in the drug and device development process have an interest in being prepared for the audit process. Attending this Webinar is a good step toward learning the FDA processes and why the Sponsor's / CRO's Monitors are so important.
Areas Covered in the Session:
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
Who Will Benefit:
This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology, and CRO industry Conducting Clinical Trials including:
Event Fee: One Dial-in One Attendee Price: US$150.00
Compliance4All DBA NetZealous,