SCDM Education Portal

The Secrets of 21CFR Part 11 Revealed

 

 

 

Overview

The Code of Federal Regulations, or CFR, contains the rules that translate laws into explanations of what must happen to comply with those laws.  Title 21 of the CFR covers much of what we do in regulated clinical research. Part 11 deals specifically with aspects of using electronic data systems in that research. 

This webinar will review the contents of 21CFR Part 11, discuss some implementation considerations, and explain some of the myths (and non-myths) around its application in clinical data management.  

Participants will understand the importance of 21CFR Part 11 and how their actions each day can affect their organization’s compliance with the regulation.  They will have a high-level understanding of the steps involved in following the regulation, and be able to discuss what aspects of the regulation affect the systems they use. 

 

The webinar will consist of a 60-minute presentation, followed by 30 minutes for questions, debates and exchange of ideas.

 

Learning Objectives


Attendees will learn to:

 

  • List the 3 main sections of 21CFR Part 11
  • Explain the intent behind each section
  • Describe at least 3 myths around 21CFR Part 11 and provide the real story behind them
  • Exercise judgment in determining what parts of 21CFR Part 11 should apply to different kinds of electronic systems used in clinical research
  • Explain at a high level the steps for installing and ensuring the correct performance of software (IQ, OQ, PQ)

 

Who should attend

This webinar is intended for Clinical Data Managers, EDC and database programmers, CRF designers, CRO auditors, Clinical quality auditors and for any professional involved in evaluating, selecting or implementing data systems in clinical research.  

 

Meet the presenter

 

Katherine (Kit) Howard, Director of Education and Medical Device Standards Development Co-Lead, CDISC

Kit Howard has over 30 years of experience in many aspects of clinical research, including the development of data and process standards for exploratory through post-marketing clinical trials. She currently works for CDISC as their Director of Education and also co-leads the medical device standards development team. She is a CCDM, a past participant on the SCDM editorial board, and an authorized instructor for CDISC’s data capture standard.

 

Earn CEUs

 

Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assesment deadline.

 

SCDM is authorized by IACET to offer 0.2 CEUs for this program.

 

Any questions? Please contact us at info@scdm.org