QSIT - Quality System Inspection Technique

This course has been designed to understand the FDA QSIT. Learn the inspection process, what FDA investigators will look at, and specific subsystems of management / design controls, production / process controls (P&PC), and corrective / preventive actions (CAPA).

Course Benefits
Participants will understand the FDA and its relationship to QSIT (Quality System Inspection Technique) and the inspection process.

Who Should Attend?
The target audience for this course consists of executives, top management who work in quality (QA/QC), compliance / regulatory affairs, manufacturing (operations, production, process, corrective / preventive actions).

Prerequisites:
Medical Device background, those in quality / regulatory affairs, those that work directly with FDA / inspections, those interested in FDA Quality System Inspection Technique (QSIT).

Topics Covered

• Module 1 – Legal and Regulatory Organization
  • Understand the structure of US laws and regulations pertaining to medical devices and their implementation
  • Describe the history of the Food, Drug, and Cosmetics Act
  • Distinguish between citations of law and regulations
  • Distinguish between FDA guidance documents and FDA recognized consensus standards
  • Describe important definitions related to devices
  • Recognize the FDA Centers and their role in device regulation
  • Describe the role of inspection and the QSIT in FDA compliance activities
• Module 2 – Management Controls
  • Understand the responsibilities and authorities of top management and the Management Representative in the Quality System Regulation including Management Review and Quality System Audit.
  • Compare and contrast the FDA’s QSR with ISO 13485 and historical versions of ISO 9001
  • Recognize there are rare instances when QSR is not required for a medical device
  • Understand the definition and role of the quality policy
  • Understand the definition of “management with executive responsibility” and their authority and responsibility
  • Understand the requirements for conducting management reviews and the expected review frequency
  • Understand the requirement for a written quality plan and the expected contents
  • Understand the requirement for procedures and instructions
  • Understand the definition of quality audit and the requirements to conduct audits and re-audits
• Module 3 – Design Controls
  • Understand the requirements and records for medical device design, including risk management and software validation.
  • Explain which devices are subject to design control
  • List the requirements for design and development planning
  • Understand design input including intended use and including patient and user needs
  • Compare and contrast design input and design output, showing how they are related
  • Compare and contrast design verification and design validation
  • Identify when software validation is appropriate for device design
  • Identify when risk analysis is appropriate for device design
  • Describe the role of design transfer
  • Understand the requirements for design changes including potential 510(k) revisions
  • Describe the contents of the design history file
• Module 4 – Corrective and Preventive Actions
  • Understand the difference between correction, corrective action, and preventive action and explain how they apply to medical devices.
  • Compare and contrast correction and corrective action
  • Compare and contrast corrective action and preventive action
  • Describe the analysis of quality data to identify existing and potential causes of nonconformities
  • List some appropriate statistical methods for quality data analysis
  • Explain the role of validation in the CAPA system
  • Explain the role of verification in the CAPA system
  • State the requirements to disseminate information about corrective and preventive actions
• Module 5 – Production and Process Controls
  • Understand the requirements for production processes applied to medical devices, including purchasing, process validation, and control of nonconforming material.
  • Describe the four items required for a manufacturer to evaluate suppliers, contractors, and consultants
  • Identify the document control requirements for purchasing data
  • Describe the five essential items required when process controls are necessary
  • Describe the requirements for production and process changes
  • State the requirements for environmental controls when they are necessary
  • State the requirements for personnel, including maintenance personnel
  • State the requirements for contamination control
  • State the requirements for production equipment including maintenance and inspection of maintenance
  • Define manufacturing material and its control
  • Identify automated processes and state the associated validation requirements
  • State the requirements for IM&TE, including calibration and associated records
  • State when a process must be validated and associated requirements
  • Compare and contrast the types of acceptance activities
  • Define the requirements to indicate acceptance status
  • Compare and contrast correction and corrective action
  • Compare and contrast repair, rework, and regrade
• Module 6 – Facility and Equipment Controls
  • Understand that sterilization process always require validation. Otherwise, they have the same requirements as Production and Process Controls
  • State why sterilization always requires process validation
  • Explain the primary device specification for sterilization processes, the target Sterility Assurance Level (SAL)
  • List the traditional methods of sterilization
  • Explain the considerations in selecting a contract sterilizer
• Module 7 – Sterilization Process Controls
  • 70(c) Environmental control
  • 70(e) Contamination control
  • 70(f) Buildings
  • 70(g) Equipment
  • 72 Inspection, measuring, and test equipment
• Module 8 – Records, Documents, and Change Controls
  • Understand the requirements for material control including installation and servicing.
  • State the material identification requirements
  • State the conditions when traceability is required and resulting action to take
  • Explain the requirements to handle device labels including clearance and inspection
  • Recognize that device packaging and shipping container requirements are design inputs
  • List the reasons to establish a handling system as part of QSR
  • List the QSR requirements for storage
  • List the required information in distribution records including control numbers
  • Identify devices that require installation and the associated documentation requirements
  • List the documentation requirements for a device that is serviced
  • State the requirements for analysis of service reports
• Module 9 – Material Controls
  • Understand the requirements for records, including the DMR, DHR, QSR, and complaint files.
  • State the requirements for initial issue of a document
  • State the requirements for revision or change to a document
  • State the requirements for the location and removal of documents
  • State the record retention requirements for device records
  • Compare and contrast the records that a manufacturer must supply to the FDA and the exempt records
  • State the role of the Device Master Record (DMR)
  • Explain the role of the Device History Record and its relationship to the Device Master Record (DHR)
  • State the role of the Quality System Record (QSR)
  • Explain the allocation of records among the DMR, DHR, and QSR
  • State the definition of a complaint
  • Explain the types of complaints that must be investigated
  • Compare and contrast the MDR requirements with complaint handling requirements

Please Note: Price includes materials, and certificate of attendance