Skip to main content

IEH Academy

Menu
SIGN IN

Validation of Electronic Record Keeping Systems to Meet the 21 CFR Part 11 Regulation

Course details

Self-Paced eLearning

99.00

1 Hour

Mark Deniston

Electronic record keeping systems are widely used to manage required production, quality, and regulatory records. When electronic records are used to meet FDA predicate rule requirements, these systems must be validated to support compliance with 21 CFR Part 11. This course reviews key FDA 21 CFR Part 11 expectations for electronic records and electronic signatures, including system validation, password controls, audit trails, system security, record review, and documentation. Learners will also explore the major validation activities used to demonstrate that an electronic record keeping system is installed, operated, and performing as intended.
ENROLL NOW

Benefits and Learning Objectives

After completing this course, participants will be able to:

  • Explain the purpose of 21 CFR Part 11 and when it applies to electronic records
  • Identify key Part 11 requirements, including electronic signatures, audit trails, and system security
  • Describe the main steps and documentation used in a Part 11 validation project
  • Understand how password controls and user access help protect electronic records
  • Recognize the importance of audit trails, record retention, and record review
  • Understand how IQ, OQ, and PQ confirm that an electronic record keeping system is properly installed, operated, and performing as intended

Topics Covered:

  • 21 CFR Part 11 Regulation History
  • Electronic Record Keeping for USDA/FSIS Facilities
  • 21 CFR Part 11 Validation Main Points
  • Validation Frameworks by Industry
  • 21 CFR Part 11 Validation Procedures

Who Should Attend?

  • Quality assurance professionals
  • Regulatory compliance professionals
  • Validation specialists
  • Production and operations personnel
  • Professionals responsible for electronic record keeping systems
  • Personnel involved in system validation and documentation

Registration and Payment

To register for this course, please visit our training portal.

ENROLL NOW
Professional headshot of Mark Deniston.
  • Vice President, Process Engineering
    IEH Laboratories & Consulting Group

Meet the Instructor

Mark Deniston

Mark Deniston has worked with IEH since 2005. He earned his M.S. in Food Engineering from UC Davis and his B.S. from Cal Poly. He has published papers on heat transfer to foods with particles, heat transfer to food products heated in steam/air retorts, and hyperfiltration technology for protein recovery. Deniston also was co-author of a National Food Processors Association (NFPA) book on automated control system validation. Deniston has taught numerous workshops and courses such as the FDA Advanced Low Acid Canned Foods Workshops, NFPA and IEH Thermal Processing, Aseptic Processing and Process Deviation Workshops, and Better Process Control Schools.

At IEH, Deniston conducts evaluation studies on automated control systems, 21 CFR Part 11 electronic record keeping systems, retort systems, and aseptic processing and packaging systems. He also recommends LACF and acidified thermal processes and evaluates LACF and acidified thermal process deviations. Deniston has held a part-time UC Davis position for 39 years, and before working at IEH, he worked at the NFPA Western Research Laboratory for 19 years in thermal processing and environmental engineering.