Webinar on Good Preparation Practices for FDA and Notified Body Audits

Description :

Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes leading to 483s and even warning letters. 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.

An FDA inspection can be a very stressful and challenging experience. These stresses can lead even experienced people to make very costly mistakes during an inspection. Good preparation can ease the stresses and lead to much more favorable results. 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.

Areas Covered in the Session :

FDA Inspection Overview

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

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1633