2-day In-person Seminar

Death by CAPA - Does your CAPA Program need a CAPA?

Director :
Susanne Manz

Date: April 18th & 19th, 2019
Time: 9:00 AM to 6:00 PM
Location: Boston, MA
Venue: Embassy Suites Boston Logan Airport
Download:  Seminar Brochure

use this promo code GCP50 to get 50% off.

1 attendee

  • $2,000.
  • Regular Price: $2000.
  • Register for 1 attendee

5 attendees

  • $10,000.
  • Regular Price: $10,000.
  • Register for 5 attendees

10 attendees

  • $20,000.
  • Regular Price: $20,000.
  • Register for 10 attendees
Course "Death by CAPA - Does your CAPA Program need a CAPA?" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

This 2-day seminar 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 seminar is for you.

We'll discuss regulatory 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.

This seminar will provide detailed lectures on all elements of a CAPA program and how they connect to other parts of your Quality Management System. You will learn how to create a CAPA program that results in improved product quality, reduction in compliance issues, and ultimately leads to improved business success.


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 an 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.

CAPA is so important that it is always emphasized in FDA inspections. It is consistently one of the top reasons for 483 and Warning Letter observations. It is critical that your company establishes a compliant, effective process. This seminar will also provide tools and checklists to ensure your program is inspection ready.


Objectives

  • Understand the regulatory requirements
  • Elements of creating an efficient and effective program
  • CAPA process, tools, and techniques
  • Linkages to your Quality Management System
  • Myths, Challenges, and Best Practices
  • Inspection preparedness

Who Will Benefit:

  • Quality Systems Specialists
  • Document Control Specialists
  • Quality and Compliance Specialists
  • Quality Engineers
  • Internal Auditors and Managers
  • Training Specialists
  • CAPA Specialists
  • CAPA Managers
  • Supplier Quality Engineers and Auditors
  • Quality/Compliance managers or directors for Medical Device companies
  • General Managers wanting to learn how to understand Quality System requirements

Day 1 Schedule


  • FDA expectations for CAPA
  • Lessons Learned from 483s and warning letters
  • Common problems with CAPA
  • Elements of a CAPA program
  • 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 CAPAs
  • Sources of Data
  • Analysis of Data
  • Failure Investigation
  • Root Cause Analysis

Day 2 Schedule


  • CAPA Project Management
  • Problem Solving and Improvement techniques
  • Effectiveness Checks
  • Control, Monitoring, Dissemination of Information
  • Connections within your Quality Management System
    • Non-conforming Product
    • Corrections and Removals
    • Change Control
    • Statistical Techniques
    • Risk Management
  • Bullet-proof Reports
  • Inspection Readiness and Checklists
  • Best Practices
Want to register by P.O/Check?

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Complete your registration in just a few easy steps

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Following this just send us your purchase order by fax at 302 288 6884

In case you wish to register by using check

In case you wish to register by using check, please make a check to NetZealous LLC DBA GlobalCompliancePanel.com and mail it to the below address.

NetZealous LLC,
DBA GlobalCompliancePanel,
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
Phone: 1800 447 9407
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Speaker

Susanne Manz

Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc.

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 worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. 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 is a CQA (Certified Quality Auditor) 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.

Susanne's new book on Medical Device Quality Management Systems - Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.

Location: Boston, MA
Hotel: Embassy Suites Boston Logan Airport, 207 Porter St, Boston, MA 02128, USA


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