Medical Device Current Good Manufacturing Practices

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Medical Device Current Good Manufacturing Practices
Level: Beginner
Lecture Hours: 16.00
Lab Hours: 0.00
Total Contact Hours: 16.00

Description

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.

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.