🎤  Meena Chettiar       |  📅  August 25, 2023   |  🕒  11 AM Eastern Time US

Who Should Attend: 

A must attend webinar for teams in:
  • Manufacturing Departments
  • Process Engineering
  • Research and Development Departments
  • Design Assurance Departments
  • Quality Assurance Departments
  • Quality Control Departments
  • Quality Engineers
  • CAPA Coordinators
  • Sterilization and Production Cleanroom maintenance Teams
  • Document Control Departments
  • Regulatory Departments


Large and small medical device companies have a challenge in preparing for and dealing with FDA audits. Quality and Manufacturing personnel in charge of creating and maintaining your quality management system for all of the medical devices manufactured at your facility should be familiar with FDA auditors’ expectations.

This webinar presents important facts to simplify the planning and execution to ensure that the findings by FDA as 483s or as the more serious warning letters are addressed appropriately so your quality system is always audit proof and ready for the QSIT Inspectors.

After having successfully emerged out of a FDA 483 or a warning letter for your medical devices, it is a challenge to maintain the items that you promised to “correct” in your response letter to the FDA as the FDA auditors will dig deep into those items. Hence items that can be scrutinized under a mock QSIT audit by experienced auditors / consultants to confirm your readiness for an unannounced FDA audit will be covered. How to perform a risk-based mock QSIT assessment for your medical device quality system for the key QSIT checklist items will be covered in this webinar.

Areas Covered in the Session:

  • Unique QSIT Subsystems and assessment process
  • Major considerations in the regulatory requirements for:
    • Management Controls
    • Product design Controls
    • Production and Process Controls
    • CAPA Subsystem
    • Sterilization Controls and associated document system controls
  • How to lay a strong foundation for fulfilling FDA’s QSR
  • Latest GMP regulations for medical devices
  • Recent findings by FDA 483s and more serious warning letters
  • Preparing and Executing Audit Proof Quality System
  • Challenges in maintaining the promises made in your response letter to FDA
  • Unannounced FDA audit Readiness
  • How to perform a risk-based mock QSIT assessment
  • Essential components of a well-documented quality system

Topic Background: 

After the final FDA approval and initiation of marketing of your medical devices, regulating bodies such as US FDA sends their inspectors on a periodic basis to manufacturing facilities. FDA auditors are trained to perform what is called a QSIT Audit. It is very important to understand the subsystems focused on by the QSIT auditors and know the FDA expectations if they find non conformities in your quality management system for your medical devices. Often experienced non FDA auditors are called to perform mock QSIT audits to gauge the pulse of quality systems before a FDA audit as a sanity check, in preparation for the visit of the FDA QSIT Audits. This presentation will discuss the key preparation steps for FDA QSIT audit of your medical device manufacturing quality system.

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