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Awareness Program on USFDA - Quality system regulation as per 21 CFR-820

Feature:

This course is designed to meet the requirement of competent auditors referred in ISO 19011. The course includes class room sessions coupled with syndicate group exercises to enhance delegate participation to achieve learning objectives. Medical Devices - Quality Management System that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support).

Course Objectives

This course is designed for awareness of the Quality system regulation as per 21 CFR-820 for medical devices. The course includes class room sessions coupled with exercises to enhance delegate participation to achieve learning objectives. Quality system regulation provide good manufacturing practice requirements for medical devices in the US. The requirements govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.

About Training Program

Generally anyone involved in Medical Devices Industry but specifically:

  • Quality executives/managers
  • R& D Personnel
  • Regulatory Affairs personnel
  • Management representatives
  • QMS Consultants
  • MD Importers
  • MD Software developers/validators
  • Personnel wishing to attend higher level courses such as Lead Auditor courses.

  • All delegates should have reasonably good understanding on quality management principles, concepts & basic requirements of ISO 9001:2015 and ISO 13485:2016
  • It is desired but not essential to have regulatory background of medical devices
  • Knowledge of English is essential

All the delegates / participants must arrange their own hard copy of ISO 13485:2016 standard throughout the online program. This is essential requirement.

  • What’s New - Introduction to 21 CFR 820
  • Manufacturer’s responsibility towards 21 CFR 820 compliance
  • Global alignment
  • QSR elements
  • Structural relation to ISO 13485:2016
  • Key definitions
  • QSR requirements (Subparts A–O)
  • Medical device classification as per US FDA
  • Guidance on FDA listing, Premarket notification 510(k) and FDA approval
  • Medical device reporting

Certificate of successful completion shall be issued to all the delegates who attend entire duration of the course and pass the online exam.

8 Hours including a break of 1 hour for both days