Medical Device Current Good Manufacturing Practices

Medical Device Current Good Manufacturing Practices

Learn the principles, requirements, and expectations of Current Good Manufacturing Practices (CGMP) for medical device production. Topics covered include the regulatory definition of what constitutes a medical device, the division of the FDA responsible for medical device applications and compliance, and how the risk-based regulatory categorization of medical devices affects the scope of applicable CGMPs.

This course may be taught at any location.

Level: Beginner
Lecture Hours: 16.00
Lab Hours: 0.00
Total Contact Hours: 16.00

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Topics Include

  • Introduction, FDA and Enforcement
  • Medical Device Regulatory Guidance Overview
  • Medical Device Registration
  • Investigational Device Exemption Regulations
  • Medical Device Regulations (21 CFR 820)
  • Medical Device Recalls and ISO
  • Buildings and Facilities
  • Production and Process Controls
  • Records
  • Safety Alerts
  • Products and Medical Procedures
  • Medical Device Safety
  • Combination Products

Learning Objectives

  • Understand the need for and processes for regulation and enforcement of medical devices.
  • Gain an understanding of the reasons for producing safe and effective products using cGMP.
  • Understand the consequences of failing to produce safe and effective products.

Audience

Any employee that works or wants to work in the medical device industry.