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Medical Device Data Integrity and FDA 21 CFR Part 11 Compliance Training

FDA Part 11 compliance involves so much more than e-signing documents and storing them securely.

Medical device RA/QA professionals focus so much on document creation and data collection that they sometimes overlook the importance of proper record maintenance and data integrity. This neglect often results in findings during FDA inspections.

In this instructor-led class, we will guide you through all facets of compliance with FDA 21 CFR Part 11 requirements governing electronic signatures and records. You’ll see excepts from several actual warning letters referencing data integrity, and review six common misconceptions that companies have about Part 11 compliance. Moreover, you’ll learn about the linkages with cybersecurity and validation in document and data management systems.

At the conclusion of this class you will understand why FDA places so much emphasis on computer system controls, how Part 11 ensures data integrity, the “predicate rules” related to electronic records, and your overall Part 11 obligations.

All attendees must have a basic familiarity with FDA 21 CFR Part 820.  For a basic foundation in Medical Device Quality System, consider our FDA QSR and ISO 13485 Foundation Class.

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Course Detail

What You Will Learn

At the conclusion of this workshop, you will be able to:

  • Describe 21 CFR Part 11 requirements for electronic records and signatures.
  • Understand why FDA places emphasis on computer system controls of data integrity validation.
  • Describe the regulatory requirements for QMS software systems.
  • Understand and implement the requirements for electronic signatures.
  • Identify Part 11 compliance “red flags” that FDA investigators look for during an inspection.  
  • Understand the predicate rules contained in other FDA QSR subparts and how they relate to electronic records.
  • Understand what needs to be done to properly manage copies of records and their backups, plus document retention rules.
  • Understand why it’s best to apply critical thinking skills and a risk-based approach to validation rather than focus on cost containment or audit defense.
  • Confidently assess the steps to protecting the integrity of your data and limiting access to authorized individuals.
  • Articulate the steps needed to implement a proper audit trail.
  • Formulate the steps to create an internal culture around data integrity.

Who Should Attend

Recommended for quality assurance and regulatory affairs professionals, as well as other cross-functional team members in a medical device environment.

All attendees must have a basic familiarity with FDA 21 CFR Part 820. 

Virtual Class Days

Virtual classes run 2 consecutive 1/2 days, from 1:00 - 5:00 PM Eastern time.

  • Virtual Half-Days

    2
  • In-Person Full-Days

    1
  • CEUs

    0.8

Virtual Session Details

Virtual Session Details

Oriel STAT A MATRIX virtual instructor-led training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

Virtual Instructor-Led Training Schedule

  • This training is delivered as 2 consecutive half-day sessions.
  • Daily sessions run from 1:00-5:00 p.m. Eastern Time. 
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

  • PC MAC Computer

    PC or MAC Computer

  • Reliable Internet

    Reliable Internet

  • Video Webcam

    Video Webcam

  • Headset or Earbuds

    Headset or Earbuds

  • Quiet Setting

    Quiet Setting

  • Two Monitors Recommended

    Two Monitors

Virtual Session Details

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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