iso13485Quality System Regulation (QSR) for Medical Devices CGMP 21 CFR Part 820


Delivered in-house, this interactive and practical workshop is designed to provide the latest information on Quality Systems Regulations (QSR) and product safety requirements in the USA and demonstrate how companies wishing to sell their medical devices in the USA can meet these regulations.

Course Objectives

This introduction carefully examines the requirements of the QSR and product safety in order to prepare companies for the design requirements.

Key Skills / Learning Objectives

Through the combination of interactive tutorials and workshops, our course will enable the delegates to:

  • Interpret the requirements of QSR and its relationship with MDD/IVDD and ISO 13485/ISO 9001 requirements.
  • Identify the methods for successful implementation of the Regulations
  • Prepare for an FDA QSIT-type audit and add value to an organisation's management system.

Course Outline

  • The FDA requirements and how they might affect an organisation.
  • Implementing the requirements effectively so as not to affect other regulatory requirements.
  • Locating key pieces of information within the appropriate documents (DHF, DMR and DHR).
  • Review of related standards such as risk analysis and the applicable guidance documents.
  • The relationship between QSR and the MDD/IVDD and ISO13485/ISO9000 requirements.
  • The regulatory requirements for reporting incident/near incidents (MDR).
  • Addressing 21 CFR Part 11 Electronic Signature and Records.
  • Adding value to an organisation's management system.
  • Preparing for an FDA QSIT type audit.
  • Sources of information and further development

Who Should Attend?

  • Executives and Senior Management
  • 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

Booking and Course Fees

Fees include:

  • Delegate workbook, including reference information
  • Training provided by qualified and experienced tutors with extensive practical management auditing experience across a variety of manufacture and service industries
  • Certificate verifying attendance and completion of course

This course is for delivery in-house only. Offering better value for money, in-house training can be customised and designed to meet specific individual and company needs.

Please Contact us to discuss your in-house requirements.

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