How to Prepare for a FDA inspection and prepare response to 483's and warning letters.


Ed is Keynote Speaker at ComplianceKey. He is retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing. He now consults internationally in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis. Ed has a B.S. Mechanical En........

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 483's and warning letters.

Why should you attend this webinar?

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 & what not to say
  • Internal/ mock audits
  • 483 response
  • Warning letter response

Who can Benefit:

  • Engineering
  • Quality management
  • Corporate management
  • Manufacturing Management


Webinar Id: LSHC0004

Training Options:

Duration: 60 mins

  24-Aug-2016

 10:00 AM PT | 01:00 PM ET

 Single Attendee: [Only for one participant]

$179 (Live)                    $319 (Live + Recorded)

 Multiple Attendee: [For a group of 2-5 participants]

$368 (Live)                    $495 (Live + Recorded)

 Corporate Attendee: [For a group of 6-10 Participants]

$741 (Live)                    $1157 (Live + Recorded)

 Recorded: [Six month unlimited access]

$167 (Single Attendee) $599 (Unlimited Attendee)

Refund Policy
Past Webinar of Edwin Waldbusser
21 CFR part 11 Compliance - el....
Presenter: Edwin Waldbusser
6 months unlimited
Price: $167
21 CFR part 11 Compliance - El....
Presenter: Edwin Waldbusser
6 months unlimited
Price: $231

More Webinar

Past Webinar: Life Sciences and Healthcare
COVID19 and Telehealth: Clarif....
Presenter: Coy Murchison
6 months unlimited
Price: $179
HIPAA and COVID19 - Do's and D....
Presenter: Brian L Tuttle
6 months unlimited
Price: $189

More Webinar

Insert title here
Pay Pal Logo   PayPal Verified Logo   GoDaddy Certified
Copyright © 2020 Compliance Key . All Rights Reserved. Back to Top