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Bioethics Events

Monday, February 24th, 2020
Event Tile: How to Prepare for and Manage an FDA Inspection
LOCATION: Middletown, DE, Delaware, United States
WEBSITE: https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=1559&speakerid=262&source=BE_LN
CONTACT: Compliance Key
EMAIL: support@compliancekey.us
TELEPHONE: 7172088666
DETAILS:

Topic : How to Prepare for and Manage an FDA Inspection

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

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 Keynote 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 : support@compliancekey.us
Phone : +1 717-208-8666