info@247compliance.us +1-661-336-9555

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

instructor
By: Edwin Waldbusser
Recorded Session
Duration
60 Minutes
Training Level
Intermediate to Advanced

Email Reminder

Transcript

Recorded Session

Training CD

For multiple location please contact our customer care team
Contact: +1-661-336-9555.



$

Webinar Details

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, and 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

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.

  • 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

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

instructor

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. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

Upcoming Webinars