2022 - How to Prepare For and Host a FDA Inspection and Respond to 483's

OVERVIEW
In this webinar, you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one. You will learn about the types of FDA inspections, preparations such as assigning personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock audits, how personnel should conduct themselves during the inspection, the inspection process and how to respond to 483s and warning letters. How to respond and when is critically important. Also covered will be the FDA’s rights during the inspection and documentation you are not required to show them.
WHY SHOULD YOU ATTEND?
FDA will inspect you! Are you ready? FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483s than a disorganized company. If a 483 is received knowing how to respond will lessen the chances of receiving a Warning Letter.
LEARNING OBJECTIVES
Personnel preparation
Procedure to follow during audit-what to do/ what not to do
Facility requirements to support inspection
Behavior during inspection-what not to sign
Internal/ mock audits
483/ Warning Letter response
WHO WILL BENEFIT?
This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, fields. The employees who will benefit include:
Executive/senior management
Regulatory management
QA management
Any person who may have direct interaction with FDA officials
Consultants
Quality system auditors
Quality Engineers
Compliance Specialists
Compliance Leaders
CAPA Specialists
Management Representatives
Compliance Managers and Directors
Quality Managers and Directors
Consultants and Contractors
SPEAKER PROFILE
Edwin Waldbusser, is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA.
For more detail, please click on this below link:
https://bit.ly/3qWcOuz
Email: info-AT-247compliance.us
Tel: +1-661-336-9555
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