The Most Frequent 483's for Medical Device Companies in 2022

This online seminar will present the most frequent 483’s for medical device companies in Fiscal Year (FY) 2022.

During an inspection, FDA investigators may observe conditions they consider objectionable against the Quality System Regulation (QSR) or Good Manufacturing Practices (GMPs). These observations are listed on an FDA Form 483.

A review of the most frequent 483’s can serve as a reference to compare the state of compliance in our organizations.

• Understanding the FDA inspection technique – QSIT
• Learning the most important quality management system’s subsystems for the FDA
• Learning the most frequent 483’s for medical device companies in Fiscal Year 2022
• Learning the trends in the 483’s for the past 5 years (2018-2022)
• Identifying the sub-systems of the Quality Management System with most observations
• Identifying the key requirements of those sub-systems and how to maintain compliance.

• FDA inspection technique – QSIT
• Most important quality management system’s subsystems for the FDA
• Most frequent 483’s for medical device companies in Fiscal Year 2022
• Trends in the 483’s for the past 5 years (2018-2022)
• Sub-systems on the Quality Management System with most 483s
• Key requirements for the sub-systems with more 483s and how to maintain compliance.
• How to prepare for an FDA inspection

Learning the most frequent FDA 483s can serve as a reference to compare the state of compliance in our organizations.

• Quality Director
• Site Quality Manager
• Quality Systems Manager
• Quality Systems Specialist
• Quality Systems Technician
• Internal Audits Manager

Vanessa Rivel has 15 years of experience in the medical device sector. Her background includes regulatory affairs, quality systems, auditing, and training. Currently, she works as an independent consultant. Her past work experience includes roles as a Quality Systems Engineer at Hospira, Quality Transfer Engineer at Boston Scientific, Site Quality Manager at  Sterigenics, and Quality Systems Manager at Precision Concepts Group. She has completed her Meng in Industrial Engineering and MBA In Marketing and Licentiate in Chemistry. She holds a certificate for Regulatory Affairs Certified (RAC), Certified Lead Auditor ISO 13485 (Exemplar Global), Certified Manager of Quality / Organizational Excellence (ASQ), Certified Quality Engineer (ASQ), Certified Six Sigma Green Belt (ASQ), Medical Device Master Auditor (ASQ), and Certified Quality Auditor (ASQ),