21 CFR Part 11 Basic Concepts for FDA Regulated Companies


21 CFR Part 11 Basic Concepts for FDA Regulated Companies from PHONIZE, USA
Now on Mobile Devices


21 CFR Part 11 Basic Concepts for FDA Regulated Companies from PHONIZE, USA
Now on Mobile Devices

Continuous technological innovation and computer­ized systems provides inherent security and regula­tion concerns within the industry. This presenta­tion provides an overview of and an historical perspective on the Part 11 regulation, including general, electronic records, and electronic signa­ture requirements.


This comprehensive course provides clear guidance to project managers, IT managers and quality assurance personnel on how to formulate and deliver best practices in regards to Part 11 to their individual teams.



  • A comprehensive history and detailed overview of 21 CFR Part 11
  • Specifics on Subpart A: General Provisions
  • Specifics on Subpart B: Electronic Records
  • Specifics on Subpart C: Electronic Signatures
  • Complete scope of regulations and their direct applications


  • Project/Strategic Management
  • Quality Assurance staff
  • IT staff
  • Operations staff
“Our quality managers enjoyed using EYEQ and I appreciated how time and resource effective it is to offer mobile training to my staff.”

Critical, regulated training provides compliance, improves processes, reduces negative reviews, and improves work consistency.

Provides a clear approach to understanding the history and reasoning behind electronic records and software regulation for project management personnel, IT staff, operations staff and quality assurance personnel.

Clear, step-by-step guidance helps ensure strategy for delivering high-quality products at a profit with consistent operation of all systems.

Provides skill-building and leadership training for regulated industry professionals with RAPS credit — available now on Mobile Devices.

Utilizes an easy, fast and engaging approach to learning using challenges, game theory and social feedback capabilities.

EYEQ is the World’s Easiest to Use Mobile & Social Enterprise Talent Development Platform 

Course Author Bio

Ms. Angela Bazigos
Chief Compliance Officer and Head of Life Sciences

Honored by Stanford Who’s Who for contributions to the Life Sciences Industry, Angela has more than 40 years of experience working with life sciences and healthcare organizations around the world. She is a Past President of PRCSQA, a member of the SQA, CVIC, ASQ, DIA and RAPS. She co-authored Computerized Systems in Clinical Research/Current Data Quality and Data Integrity Concepts with FDA and is a frequent contributor to international and industry publications. Ms. Bazigos was recently quoted in the Wall Street Journal on Using Training to Bring Compliance to the Boardroom. Ms. Bazigos additionally served as CCO for Prime Genomics, and held executive roles at Incyte Genomics, Roche and Counsyl among others.