21 CFR Part 11 for the Clinical Data Manager

1 part webinar
60-minute presentation followed by 30-minute Q&A

 

 


 

Why You Should Attend
Participants will understand and be prepared to be involved in 21 CFR Part 11 compliance through user validation and process documentation.

 

Overview
Clinical trial software systems must meet the requirements of Title 21 Code of Federal Regulations (CFR) Part 11. This regulation requires both developer validation and user validation. Clinical data managers may be involved in 21 CFR Part 11 compliance through user validation and process documentation. Validation activities involving clinical data managers include specification of user requirements, identification of functional specifications, risk assessment or user testing. In addition, clinical data managers are often involved in the acquisition process for clinical trial software and must understand 21 CFR Part 11 software specifications. This webinar will describe the requirements of 21 CFR Part 11 and the validation process.

 

What You’ll Learn
Upon completion of this program, attendees will be able to:

  1. Identify the requirements of 21 CFR Part 11 compliance.
  2. Describe the difference between developer and user validation.
  3. Identify the validation activities in which a CDM would be involved.
  4. Identify software specifications related to 21 CFR Part 11 compliance.


Meet the Presenter
Computer System Validation's principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation.  He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications.  He has completed more than 200 mission critical laboratory, clinical, and manufacturing software implementation projects.  His most popular book is Risk-Based Software Validation- Ten Easy Steps (Davis Horwood International and PDA- www.pda.org, 2006), which provides fill-in-the-blank templates for completing a COTS software validation project.  

 

Who Should Attend
Intermediate to advanced, experienced CDMs and CRAs.

 

Earn CEUs      
Participants are eligible to recieve CEUs upon attendance and successful completion of assessment questions.
SCDM is authorized by IACET to offer .2 CEUs for this program.

 

 

Register