How to prepare for and host a FDA inspection and respond to 483’s

  • Speaker:Edwin Waldbusser
  • Duration:90Min
  • Product Code:GRC-90504

Live Session - How it works

  • Username and Password will be sent to you within 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
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  • Get answer to your queries through interactive Q&A sessions. The Q and A sessions are at the end of the meeting. The expert will complete his/ her presentation and then the phone lines will be open for the audience to discuss your questions.
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  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you don’t receive an email within 6 days. Please email our support@grcts.com

Recorded Session - How it works

  • Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
  • Please click on the link to access the Recording and type in the password provided in the email.
  • Presentation and other handouts will be emailed to you in a pdf format.

Training CD - How it works

  • Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.

(For more information about our products contact +1- 248-233-2049)

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. 

Overview: 

In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated 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, the inspection process and how to respond to 483s and warning letters.

Why You should Attend:

FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483’s than a disorganized company.  If a 483 is received knowing how to respond will lessen chances of receiving a Warning Letter.

Areas Covered in the Session

  • Personnel preparation
  • Facility needed to support inspection
  • Behavior during inspection-what not to sign
  • Internal/ mock audits
  • 483 response 

Handout:

  • FDA Inspection Readiness Checklist
  • Who can attend:
  • Engineering personnel
  • Engineering management
  • Quality Management
  • Corporate Management
  • Manufacturing Management
  • Division management

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 9 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.

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Available Options

Recording: Unlimited Viewing Access for 6 Months

$229

CD-DVD: Shipped within 2 working days

$289

USB - Shipped within 2 working days

$339

5 Member Group: 5 people can Attend the Live Online Meeting from any location globally

$2,459

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$3,459

Recording: Unlimited Viewing Access for 12 Months

$289

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