Event Description

The Most Frequent 483's for Medical Device Companies in 2022 2023 Mexico Mexico

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

 

https://247compliance.us/the-most-frequent-483s-for-medical-device-companies-in-2022/1947?through=Samir10thfebLI&sm_medicalevents

End Date
Start Date
Organizer
For registration/tickets purchase:
https://247compliance.us/the-most-frequent-483s-for-medical-device-companies-in-2022/1947?through=Samir10thfebLI&sm_medicalevents
Event Cost:
199 to 799
The Most Frequent 483's for Medical Device Companies in 2022
Event Capacity
10
Event Types (Select all that apply)
Medical Conference
Medical Seminar
Medical Educational Courses
Online Medical Event
Event Sponsors
247compliance
Event Registration Contact Email
info@247compliance.us
Event Information Contact Email
info@247compliance.us
CME Credit Fall Under
1-10
CME Credits
Yes
Abstract Submission Deadline
Abstract guidelines

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 483s 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

SPEAKER PROFILE

Image removed.

 

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),

(+1) 206-575-7771
Medical Events Worldwide
12922 SE 299th Street, Auburn WA 98092 USA