Understanding the 21 CFR 820 Quality Management System Regulations (QMSR)

Understanding the 21 CFR 820 Quality Management System Regulations (QMSR)

Course Duration: 2 Days

This two-day seminar addresses all of the elements of the 21 CFR 820 changes. The FDA has amended this regulation to align more closely with the international consensus standard for devices by converging with the Quality Management System (QMS) requirements of ISO 13485:2016. This course aligns regulatory understanding to the framework for the USA with that used by other global regulatory authorities to promote consistency in the regulation of devices and provide a timelier introduction of safe, effective, high-quality devices to patients

Learning Objectives

  • Explore the specifics of 21 CFR 820, ISO 13485, and the requirements of Quality Management System Regulations for medical device manufacturing.
  • Provide a hands-on approach to setting up and/or assessing QMS processes compliant to medical device regulations.
  • Provide the competencies needed to introduce new QMS processes, or changes to those processes for the manufacture of medical devices with the confidence of meeting regulatory needs.

Course Outline

  • Chapter 1: What is Changing? (QMS to QMSR)
  • Describe various changes in 21 CFR 820 and differences with ISO 13485
  • Basic background of the standard and reasons for change
  • Details of new 820.1 (Scope)
  • Details of new definitions within 820.3 and differences from ISO 13485 Clause 3
  • Breakout Exercise 1: Identify 21 CFR 820 Changes vs. What Isn’t Changing — emphasis on differences
  • Chapter 2: 820.7 Incorporation by Reference
  • List QMS regulatory requirements and the corresponding clauses in ISO 13485
  • Breakout Exercise 2: Identify References to Regulatory Requirements from both 21 CFR 820 and ISO 13485
  • 820.10: Requirements for a Quality Management System (QMS) — differences between 21 CFR 820 and ISO 13485 by paragraph/clause
  • 820.15 Clarification of concepts from ISO 13485 and how they are defined differently.
  • Breakout Exercise 3: Identify the Differences 21 CFR 820 will Require with Utilization of ISO 13485
  • Chapter 3: Subpart B – Supplemental Provisions
  • Record Control fundamentals in 820.35
  • Complaints and Servicing [sub para (a) & (b)]
  • UDI and Confidentiality [sub para (c) & (d)]
  • Breakout Exercise 4: Identify the Regulatory Requirements of Controlling Records
  • Device labeling and packaging controls in 820.45
  • Examination prior to and eventual release [sub-para (a) & (b)]
  • Setting up packaging & labeling processes [sub-para (c)]
  • Breakout Exercise 5: Define Labeling and Packaging Controls
  • Chapter 4: Introduction to ISO 13485
  • Introduction, Purpose, Patient Safety & Quality
  • Key definitions of ISO 13485 and 21 CFR 820
  • Breakout Exercise 6: Define the Purpose, Scope and Differences between 21 CFR 820 & ISO 13485.
  • Chapter 5: ISO 13485 Requirements
  • Clause 4: Quality Management System Requirements
  • Clause 5: Management Responsibility
  • Breakout Exercise 7: ID Requirement Relationships Based on Audit Scenarios for Clauses 4 & 5
  • Clause 6: Resource Management
  • Clause 7: Product Realization
  • Breakout Exercise 8: ID Requirement Relationships Based on Audit Scenarios for Clauses 6 & 7
  • Clause 8: Measurement, Analysis & Improvement
  • Breakout Exercise 9: ID Requirement Relationships Based on Audit Scenarios for Clause 8
  • Chapter 6: Process Approach/Turtle Diagrams/Audit Trails
  • Describe the use of each concept to assess a QMS
  • Breakout Exercise 10: Utilizing each concept

Who Should Attend

Those who have responsibility for having regulatory knowledge necessary for manufacturing new &/or legacy products into the USA medical device market would benefit from this seminar. This includes: Top Management, Quality/Regulatory managers, Ops managers, design engineers, manufacturing engineers, and others who have direct responsibility for medical device manufacturing, development and improvement.

Course Materials

Each participant will receive a seminar manual and a workbook including all team breakout exercises.

Note: Omnex does not provide copies of standard(s) during training courses, but clients are encouraged to have their own copy.

Pre-Requisite

Those who have responsibility for having regulatory knowledge necessary for manufacturing new &/or legacy products into the USA medical device market would benefit from this seminar. This includes: Top Management, Quality/Regulatory managers, Ops managers, design engineers, manufacturing engineers, and others who have direct responsibility for medical device manufacturing, development and improvement.

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