How to Comply with 21 CFR 11 Requirements for Electronic Medical Records 2018
02 May 2018
Webinar
Description
Topics
What are required characteristics for source documents?
What are source documents and why are they important? (FDA and ICH GCP E6 Guideline)
How can you apply 21 CFR 11 and ICH E6 to source documents?
What is 21 CFR Part 11?
How to plan electronic source document deficiencies
How EMR Data is used in Clinical investigations
What are future expectations for EMRs (FDA Draft Guidance) and the impact on sponsors and sites
How to Manage site and sponsor interactions with regards to EMR
Who should Attend
Clinical Research Coordinators
Investigators
Clinical Research Associate Managers
Device and Drug Study Clinical Research Associates
Quality Assurance Personnel
Project Managers
Doctors and Nurses involved in Clinical Trials including Monitors,Clinical Research Associates and Clinical Research Co-ordinators
Regulatory Affairs Personnel
Regulators dealing with FDA-Regulated Clinical Investigations
Past Events
How to Comply with 21 CFR 11 Requirements for Electronic Medical Records 2018 - 02 May 2018, Webinar (75254)
Important
Please, check "How to Comply with 21 CFR 11 Requirements for Electronic Medical Records" official website for possible changes, before making any traveling arrangements
Event Categories
Education: E-learning, Education Technologies & Methods, Training
Government & Global Issues: Law & Regulations
Health & Medicine: Healthcare, Medical device, Medical laboratories, Medical technology, Pharma
