Good Documentation Practices for Medical Devices

Good Documentation Practices for Medical Devices

This course presents the regulatory requirements and best practices for medical device documents, documentation, and record keeping.  Topics covered will include: a review of the differences between documents and records; the ISO 9001 document hierarchy as well as an explanation and appropriate content of each document level; record keeping requirements including the electronic signature and record keeping requirements of 21 CFR Part 11; and the appropriateness and qualification of Excel spreadsheets for record keeping.  General good documentation practices incorporating the requirements detailed in FDA's Guidance to Industry "Data Integrity and Compliance with CGMP" are also reviewed.

Audience

Manufacture/Production Operators, Team Leaders and Supervisors, Quality Control Personnel, Quality Assurance Personnel, Maintenance/Engineering Personnel

Topics Include

  1. FDA's requirements for documents and record keeping defined in 21 CFR 820 and ISO 13485.
  2. Differences, usage and purpose of documents typically found in the medical device industry.
  3. Good documentation practices as well as common errors and data omissions that occur in medical device documentation.
  4. Electronic signature and electronic record keeping requirements of 21 CFR Part 11.
  5. Regulatory definition of raw data and the emerging regulatory expectations for data

Learning Objectives

  1. Understand FDA required documents and record requirements for medical devices.
  2. Understand how to compliantly record and maintain data whether  in hard-copy or electronic format.
  3. Participants will learn regulatory expectations for data accuracy, review and integrity assurance
Good Documentation Practices for Medical Devices

Request this Course

Level: Beginner

Lecture HoursLab or Activity HoursTotal

Delivery Options

Face-to-Face
Delivered in a classroom or lab setting.
Live Instructor Led
Delivered online with a Live Instructor teaching the course at a scheduled date and time.

College Options

Colleges that are able to offer this course.

Related
Ethylene Oxide (EtO) Sterilization Validation
Course
This course provides an overview of the concept of validation with a specific focus on EtO... more
BioCertification Boot Camp
Course
All students who complete the BioWork Certificate Program successfully are eligible to take the... more
GMP and SOP Online
Course
This 24-hour online course covers six modules related to Good Manufacturing Practices (GMP) and... more
eLearning
See how clinical trials of a research drug or medical device are conducted and managed.
  •  
  • 1 of 19
  • >