How to Manage an effective FDA Quality Inspection

OVERVIEW:  
This webinar can help you be more professional and polished during an inspection. You will learn how to present information about your quality system in the most competent and professional manner.

Product Id : 501159

Instructor : Susanne Manz

Wednesday, March 15, 2017   |   10:00 AM PST | 01:00 PM EST   |   Duration: 60 Minutes

WHY SHOULD YOU ATTEND:
This webinar can help you prepare a strategy and detailed plan to more successfully prepare for, manage, and respond to an FDA or Notified Body Inspection. If you've had a recall, an increase in MDRs, or it's been more than 2 years since your last inspection, you can benefit from this webinar. 

AREAS COVERED IN THE SESSION:

• FDA Inspection basics
• Inspection preparedness strategy and planning
• Key roles during an inspection
• SME (Subject Matter Expert)training
• Checklists for preparing
• How to manage an inspection
• Common mistakes to avoid
• How to respond to inspection observations

WHO WILL BENEFIT:

• Quality Engineers
• Compliance Specialists
• Compliance Managers
• Quality Managers
• Consultants and Contractors
• Business Leaders wishing to present a professional and compliant organization
• Cross-functional leaders wanting to make sure their organizations are well prepared
• Anyone involved with an FDA or NB inspection

SPEAKER PROFILE:
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, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance.

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