How to Prepare for and Manage an FDA Inspection

Topic : How to Prepare for and Manage an FDA Inspection

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

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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 : [email protected]

Phone : +1 717-208-8666