Events

OVERVIEW

This online seminar will present the most frequent 483s 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 483s can serve as a reference to compare the state of compliance in our organizations.

WHY SHOULD YOU ATTEND?

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

AREA COVERED

• 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 OBJECTIVES

• 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.

WHO WILL BENEFIT?

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