FDA regulations and the ICH GCP recommendations

About this Conference

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