Q.S.I.T. – Quality System Inspection Technique

Who should attend

This introductory course is of value to employees at all levels within the organisation of Medical Device manufacturers, and suppliers to the Medical Devices industry including:

  • Regulatory Affairs professionals
  • Quality Assurance professionals involved in design and/or manufacturing
  • Senior management team members
  • Development engineers
  • Product Management professionals

Book onto this course

Course Outline

This enlightening 1 day course on Quality System Inspection Technique (QSIT) is a must for any medical device manufacturer who sells into the USA and will at some point have the FDA come and audit the company and the associated critical suppliers.

QSIT is a published guide applicable to the medical device industry operating under good manufacturing practice whereby FDA investigations follow a predetermined regime for conducting an inspection. This consistency makes it easier to assess preparedness and compliance.

Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA regulated products (food, drugs, biologics and devices) are known as current Good Manufacturing Practices (cGMPs). cGMP requirements for medical devices can be found in the U.S. Code of Federal Regulations – 21 CFR part 820, commonly known as the QSR (Quality System Requirements).

This course has been designed to provide delegates with the skills and knowledge to prepare for a QSIT audit to ensure that when the FDA visit, a successful outcome is achieved.

Topics covered include

  • Implementing and maintaining a 21 CFR part 820 compliant quality management system
  • Preparing for an FDA inspection
  • Understanding the requirements of the four main subsystems and linked controls

    • Management Controls
    • Design Controls
    • Corrective and preventive actions (CAPA)
    • Production and process controls (P&PC)
  • Materials controls, equipment and facilities controls, records, documents and change controls
  • What happens during the inspection
  • What happens at the end of the inspection
  • Actions arising from the inspection (Manufacturer and FDA)
  • How to remain in compliance with 21 CFR part 820 requirements.

Outcomes

  • A solid understanding of how to prepare for an FDA inspection
  • The knowledge and skills to deal with inspectors during the inspection process
  • An understanding of how to successfully deal with any actions that arise from the inspection
  • A good appreciation of how to remain in a state of compliance for all future inspections

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