How to Comply with 21 CFR 11 Requirements

Start Date : May 2, 2018
End Date : May 2, 2018
Time : 10:00 am to11:30 am

Phone : 18004479407
Email : support@compliance4All.com

Location :
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.

Website

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: support@compliance4All.com

Organized by

Organized by compliance4all14

Event Manager ,
161 Mission Falls Lane, Suite 216,

Tel: 800-447-9407
Mobile: 8004479407
Email: support@compliance4All.com
Website: http://www.compliance4all.com/


Event Categories: Health & Nutrition.




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