International conference details
FDA regulations and the ICH GCP recommendations
Fremont (United States), 6 March 2018
Domain:
Key deadlines
- Conference starts:
- 2018-03-06
Website
Conference Description
Overview:
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:
Senior Management
Project Managers
CRA Managers
QA/Compliance Persons
Speaker Profile:
Charles H. Pierce MD, PhD, FCP, CPI is a consultant in the Clinical
Research / Drug-Device Development arena specializing in bringing
the message of GCP Regulations and Investigator Responsibility to the
entire investigative team to help them understand the regulations as
well as the ethics of research involving human subjects.
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
Conference creator: compliance4all
Actions menu
Conference Location
18004479407 161 Mission Falls Lane, Suite 216,,
Fremont 94539 (United States)