Corrective and Preventive Action (CAPA) and Complaint Handling in Medical Device. - By Compliance Global Inc.
About This Event
Overview:
Have you ever wondered about how FDA approaches CAPA (corrective and preventive actions) and complaint issues during inspections? What about how they manage those activities and what they are looking for? This webinar will provide clarity around those issues from a compliance expert with over 30 years’ experience in inspection and compliance management.
Why Should You Attend:
Many companies do not know what they don’t know when it comes to dealing with the FDA. By not understanding how FDA looks at CAPA corrective action and complaint problems, these companies oftentimes fail to manage inspections to reduce the risk of adverse findings. After the inspection, they fail to address key issues in response to fda 483s and Warning Letters. Here is your chance to better understand how FDA thinks and operates in managing these key inspection systems from a former medical device compliance insider.
Areas Covered in the Session:
CAPAs and complaints are key focus areas having GMP guidelines and this webinar will review the ins and outs of how to manage these systems and effectively address questions FDA will likely raise during inspections.
Learning Objectives:
• Why CAPAs and complaints are so important to FDA
• How to be prepared for an FDA inspection of these areas
• How FDA uses data from inspections
• How to avoid or reduce risk in managing product experience data of this sort
Who Will Benefit:
• VP’s in Quality Assurance
• Directors in Quality Assurance
• Quality Managers
• Quality Professionals
• Small Business Owners
Level:
Beginner
For more detail please click on this below link:
https://www.complianceglobal.us/product/700088
Email: [email protected]
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515