Discovering FDA 21 CFR Part 820 requirements for medical devices

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Objectives

  • Understanding the terms and the vocabulary
  • Knowing the specific quality system requirements (QSR) set by US regulations (FDA) for medical devices

Audience concerned

Manufacturers/sub-contractors/distributors of MDs:
– Regulatory affairs/quality managers
– Staff with regulatory monitoring tasks
– Department Heads: Production, R&D
– Project Managers, software engineers

Aim

Acquiring the basics

Programme summary

  1. Introduction and objectives
  2. Quality System Requirements (QSR), 21 CFR Part 820, current Good Manufacturing Practices (cGMP)
  3. Other regulatory requirements
  4. FDA inspection
  5. Conclusion

Prerequisites

There is no prerequisite for this training.

Duration

1 day
7-hour classroom attendance

Inscription

Download the registration form

Date des formations CaduCeum Academy

Ref : CA21820

Informations and registration : academy@caduceum.co.uk