Ex 121 - Quality System Regulation (QSR) for Medical Devices CGMP 21 CFR Part 820


To gain a thorough understanding of the requirements of the Quality Systems Regulations (QSR) and product safety; to provide the methods for successful implementation of the regulations; to prepare companies for the design requirement and to compare the requirements of QSR with MDD/IVDD.

This ONE-DAY course is designed to provide the latest information on QSR and product safety requirements in the USA and, using case studies, workshops and interactive discussions, demonstrate how companies wishing to sell their medical devices in the USA can meet these regulations.

Key Session Topics

  • Understand how the FDA requirements will affect your business.
  • Learn how to implement these new requirements effectively and not affect other regulatory requirements.
  • Know how to locate key pieces of information within the appropriate documents (DHF, DMR and DHR).
  • Review of various standards that are being developed, such as risk analysis and the new guidance documents.
  • Understand the relationship between QSR and the MDD/IVDD and ISO13485/ISO9000 requirements.
  • Discuss and compare the regulatory requirements for reporting incident/near incidents (MDR).
  • Understand how to address 21 CFR Part 11 Electronic Signature and Records.
  • Add value to your management system.
  • Prepare for an FDA QSIT type audit.

Who Should Attend

  • R&D Managers/Engineers and Members of Design Review Teams.
  • RA/QA Managers and Management Representatives.
  • Members of multi-discipline Design Teams.
  • Sales and Marketing, Production, Shipping, MIS, Purchasing.
  • Senior Managers/VP's.

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