CAPA for Medical Devices

  • Speaker:Susanne Manz
  • Date: 21st July 2017 10:00 AM PST | 01:00 PM EST
  • Duration:90Min
  • Product Code:GRC-90141

$189

25

DAYS
Left to Register

refer

Refer Friend's


Live Session - How it works

  • Username and Password will be sent to you 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be mailed to you.
  • Login to the session using the username and password provided to you.
  • Get answer to your queries through interactive Q&A sessions via chat.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve.
  • Get certification of attendance.

Recorded Session - How it works

  • Login Information with Password to view the webinar, 24 hours after the Live webinar (link valid for 6 months).
  • A link will be provided to you upon purchase of the recorded session.
  • Please click on the link to access the session.
  • Presentation handouts in pdf format will be mailed to you.
  • Get certification of attendance.

Training CD - How it works

  • Free shipment within 72 Hours, from the date of webinar completion.

(More about our products contact +1- 248-233-2049)

This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you.

We’ll discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls. We’ll discuss best practices so you can start off on the right foot and always be prepared for an inspection.

Why You Should Attend:

Corrective and Preventive Action (CAPA) is the cornerstone of a strong Quality Management System. And yet, many medical device manufacturers struggle to establish and maintain and effective CAPA process. An ineffective CAPA process leads to disastrous consequences like complaints, recalls, 483s, and warning letters. Additionally, an inefficient CAPA system leads to wasted time and resources.

Objectives:
  • Understand the regulatory requirements
  • Creating an efficient and effective process
  • Linkages to your Quality Management System
  • Myths, Challenges, and Best Practices
  • Inspection preparedness

Topics:

This 90-minute webinar will focus on how to improve your CAPA process to optimize efficiency and effectiveness.

Topics to be covered include:
  • FDA and NB expectations for CAPA
  • Lessons Learned from 483s and warning letters
  • Common problems CAPA
  • How to structure your CAPA process
  • How to use IT tools to monitor and maintain your CAPAs
  • Metrics to ensure your CAPAs are timely and effective
  • A toolkit for CAPA
  • Best Practices
Instructor 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. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance. For more information, visit www.ManzConsultingInc.net.

Write a review

Note: HTML is not translated!
    Bad           Good

Available Options

Live Webinar

$189
For one participant.

Corporate Webinar Offer 1

$539
Group - Max 5 Participants from any Location.

With this purchase you'll get a 10% discount on same purchase.

Corporate Webinar Offer 2

$1,409
Group - Max 10 Participants from any Location.

With this purchase you'll get a 20% discount on same purchase.

Recorded Webinar

$209
Login information will be shared within 48 hours after the completion of Live webinar. Valid for 6 months with up to date materials.

Get CD/DVD

$339
Free shipment within 4 working days, from the date of webinar completion.

With this purchase you'll get a 20% discount on same purchase.

Super Combo Offer 1

$489
For One participant Live and Recorded webinar Only!

Super Combo Offer 2

$519
For One participant Live and Training CD Only!

Live Corporate Webinar

Group - Max 15 Participants from any Location.
(For more details on Pricing or to add additional members contact support)