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SOP Writing and Process Mapping for Medical Device Regulations

Documentation practices are evolving, so to avoid FDA or Notified Body findings you must stay ahead of the curve in this critical area.

In this class you’ll learn best practices and strategies to plan and improve a documentation control system, gain compliance for electronic records and signatures, and prepare for audits under the new EU regulations, ISO 13485:2016, and FDA’s QSIT. The course goes beyond compliance by demonstrating that well-written procedures reduce the potential of human error in processes and introducing concepts in writing for the audience and designing procedures to reduce cognitive overload and mistakes.

This course is a good follow-up to our Quality Systems for Medical Devices: FDA’s QSR and ISO 13485:2016 class.

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Course Detail

Objectives

  • Describe the requirements of regulations and standards (FDA, EU Device regulation and ISO 13485) as they relate to document control.
  • Plan and structure a document management system that meets new requirements for EU Technical Documentation
  • Identify software used in QMS documentation and regulation of electronic records and electronic signatures in 21 CFR Part 11
  • Apply process mapping to documentation practices to articulate process linkages for MDSAP
  • Evaluate best practices in technical writing and Good Documentation Practices
  • Review the basics in documentation, including mandatory and recommended elements for policies, procedures, and instructions
  • Develop a robust change control system linked to your design and risk control activities
  • Describe best practices in preparing for successful outcomes from FDA, notified body and MDSAP audits.

Topics

  • Documentation requirements (global regulations and standards)
  • Technical writing, process mapping, and error proofing
  • Electronic records
  • Change control requirements

Who Should Attend

Recommended for staff members involved in preparing plans, procedures, and instructions as part of a document management system.

  • Virtual Half-Days

    4
  • In-Person Full-Days

    2
  • CEUs

    1.5

Virtual Session Details

Virtual Session Details

Oriel STAT A MATRIX is known for our in-person workshops and hands-on activities, and we use an extensive toolbox to foster similar engagement and attention in our virtual classes. Our instructor and students interact in real time via our flexible, online learning platform, resulting in an engaging and real-class environment.

This is an ideal alternative to the typical classroom setting for quality and regulatory professionals who are unable to travel or who just prefer the convenience of attending a class without having to leave their own personal environment.

Online Training Schedule

  • This training is delivered as 4 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

See course dates to find / register for a virtual online session of this course.

 

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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