Live Webinar How To Comply With 21 CFR 11 Requirements for Electronic Medical Records

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Hear By Angela Bazigos who recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom"

The FDA has issued guidelines for source documentation contained in electronic medical records (EMR) in the Code of Federal Regulations (CFR) Title 21, Part 11. 21 CFR Part 11 addresses the need for controls, audit trails, electronic signatures, and software documentation for processing electronic data in the EMR.

Description

What is source documentation and why is it important?
Maintaining accurate source documentation is the cornerstone of good clinical practice.  Its purpose is to provide a comprehensive narrative of subject participation in a clinical trial from the date informed consent is obtained through to the end of the subject’s participation.  Source documentation utilizes information from the subject’s medical record including assessments, tests, procedures and other relevant medical history. Good source documentation allows an independent observer to recreate a subject’s participation in a clinical trial and to account for the use of any investigational product or device. 

The FDA has issued guidelines for source documentation contained in electronic medical records (EMR) in the Code of Federal Regulations (CFR) Title 21, Part 11.  21 CFR Part 11 addresses the need for controls, audit trails, electronic signatures, and software documentation for processing electronic data in the EMR.  

There is an increasing use of computerized systems in clinical trials to generate and maintain source data and source documentation on each clinical trial subject. Such electronic source data and source documentation must meet the same fundamental elements of data quality (e.g., attributable, legible, contemporaneous, original, and accurate) that are expected of paper records and must comply with all applicable statutory and regulatory requirements. FDA's acceptance of data from clinical trials for decision-making purposes depends on FDA's ability to verify the quality and integrity of the data during FDA on-site inspections and audits. (21 CFR 312, 511.1(b), and 812).

Why should you attend

The principles outlined in this webinar can be used for computerized systems that contain any data that are relied on by an applicant in support of a marketing application, including computerized laboratory information management systems that capture analytical results of tests conducted during a clinical trial. For example, the recommendations 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 812.140(b), such as case histories. 
This webinar also applies to recorded source data transmitted from automated instruments directly to a computerized system (e.g., data from a chemistry autoanalyser or a Holter monitor to a laboratory information system). This webinar also applies when source documentation is created in hardcopy and later entered into a computerized system, recorded by direct entry into a computerized system, or automatically recorded by a computerized system (e.g., an ECG reading).
The webinar does not apply to computerized medical devices that generate such data and that are otherwise regulated by FDA.

Areas Covered

•      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
•      How to Manage site and sponsor interactions with regards to EMR
•      What are future expectations for EMRs (FDA Draft Guidance) and the impact on sponsors and sites

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
•     Doctors and Nurses involved in Clinical Trials including Monitors, Clinical Research Associates and Clinical Research Co-ordinators
•     Regulators dealing with FDA-regulated clinical investigations

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device,Biotechnology,Pharmaceutical,Healthcare,Finance,Manufacturing,Retail Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Angela Bazigos

Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.

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