FDA Quality System Inspection Technique (QSIT) Audits – Good Preparation Practices

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.

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.

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

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

Course Director: MEENA CHETTIAR

Meena Chettiar currently works as a Quality and regulatory Manager at ProMed Pharma in Minneapolis. Meena has worked as a Senior Supplier quality engineer at Covidien, Senior Quality Associate (Lead Auditor and CAPA Coordinator) at Baxter Bio Surgery in St. Paul, MN. Meena worked as a Senior Quality Control Manager at Teva Pharmaceuticals for over 10 years and as Instrumentation lab supervisor at Land O’ Lakes. Meena has also worked for Agriculture and Health Canada in several technical capacities for about 10 years before immigrating to the United States. Meena made the transition to the medical device industry after completing a MS in Regulatory Affairs for Medical Devices through St. Cloud State University in 2010. Meena has played a key role in quality system implementations in the food, pharma, and medical device industries. Meena has participated as the lead supplier/internal/GMP auditor in several Compliance audits in the US and abroad. She has a strong auditing background in the pharmaceutical and medical device auditing. Meena is a senior member of ASQ (American Society for Quality) and is ASQ certified CQA (Certified Quality Auditor), CBA (Certified Biomedical Auditor), CQIA (Certified Quality Improvement Associate), and CMQ/OE (Certified Manager of Quality/Organizational Excellence). She has been serving as an instructor for these ASQ certification classes since 2006 and has conducted quality and medical device related training classes in her current position at Baxter. Meena is a coauthor of the CBA (Certified Biomedical Auditor) primer for the Quality Council of Indiana. She is currently an adjunct instructor for the medical technology quality program at St. Cloud State University in Minnesota. Ms. Chettiar received her M.S Regulatory Affairs and Services for Medical Devices from St. Cloud State, Minnesota, M.S. in Chemical engineering from University of British Columbia and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Meena is happy to teach webinars for the Compliance Trainings and continue to contribute towards quality and regulatory compliance.