Conference Description:

Overview:
In this webinar would apply to computerized systems that

create source documents (electronic records) that satisfy the

requirements in 21 CFR 312.62(b) and 812.

Areas Covered in the Session:
What are source documents and why are they important?

(FDA and ICH GCP E6 Guideline)
What are required characteristics for source documents?
What is 21 CFR Part 11?
How can you apply 21 CFR 11 and ICH E6 to source

documents?
How EMR Data is used in Clinical investigations
How to plan electronic source document deficiencies

Who Will Benefit:Investigators
Clinical Research Coordinators
Device and Drug Study Clinical Research Associates
Clinical Research Associate Managers
Project Managers
Quality Assurance Personnel
Regulatory Affairs Personnel

Speaker Profile:
Angela Bazigos Seasoned Executive with 40 years of

experience in the Life Sciences & Healthcare Industries.

Positions include Chief Compliance Officer

http://morflearning.com/angelabazigos/ . Experience

combines Quality Assurance, Regulatory Compliance,

Business Administration, Information Technology, Project

Management, Clinical Lab Science, Turnarounds and

Business Development.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]