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How to Prepare for and Manage an FDA Inspection

March 27 @ 3:30 pm - 5:00 pm CDT

$229

Topic : How to Prepare for and Manage an FDA Inspection

Register : https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=1559&speakerid=262&source=CC_LN

Discount Coupon : Use this Coupon (NEW2COMPLIANCE) and get (10% Off) On New Signup

Overview

Are you ready for the FDA to knock on your door? Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage inspections efficiently and effectively. A professional, polished, responsive approach sets a good tone for an inspection. You will learn how to present information about your quality system in the most competent and professional manner.

Areas Covered in the Session :

  • FDA Inspectional approach
  • Inspection strategy and planning
  • Preparing
  • How to manage an inspection
  • Key roles during an inspection
  • Training for SMEs (Subject Matter Experts) and other roles
  • Do’s and Don’ts
  • Common mistakes to avoid
  • How to respond to inspection observations

Speaker Profile :

Susanne Manz is a Keynot e Speaker at Compliance Key. Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, Johnson and Johnson, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, World Wide Director of Quality Engineering, World Wide Director of Product Quality, and Director of Corporate Compliance.

Contact Info :

Compliance Key

https://www.compliancekey.us/

Email : [email protected]

Phone :+1 717-208-8666

Details

Date:
March 27
Time:
3:30 pm - 5:00 pm
Cost:
$229
Event Tags:
Website:
https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=1559&speakerid=262&source=CC_LN

Organizer

Compliance Key
Phone:
7172088666
Email:
support@compliancekey.us
Website:
https://www.compliancekey.us/

Venue

Online Event
Compliance Key,364 E Main Street, Suite 1009
Middletown, DE 19709 United States
+ Google Map
Phone:
7172088666
Website:
https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=1559&speakerid=262&source=CC_LN