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 1. Home
 2. Services - Live Events
 3. Virtual Seminar on Death by CAPA - Does your CAPA Program need a CAPA?


VIRTUAL SEMINAR ON DEATH BY CAPA - DOES YOUR CAPA PROGRAM NEED A CAPA?


4-HOUR VIRTUAL SEMINAR

January 27, 2023- Online

 * Event InformationInformation
 * SpeakersSpeakers
 * AgendaAgenda
 * TicketsTickets

This 4-hour virtual 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 expectations, 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 virtual seminar provides 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.



LEARNING 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

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.


The full agenda is not yet available for this event.
Follow this event to receive an alert when the agenda becomes available.

--------------------------------------------------------------------------------

Time: 08:00 AM PST | 11:00 AM EST


Using lecture, discussion, case studies, and break-out groups, this 2-day
seminar will provide you with the tools to create an effective and efficient
CAPA program.  Topics to be covered include:

 * 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
 * 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 Checklist
 * Best Practices

--------------------------------------------------------------------------------


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Available in the same serie
 * On Demand from previous editions (1)

Event details Organizer :Global Compliance Panel Event type :Training Course
Attendance :Online Event Reference :ASDE-24122 EventStatus :active


AVAILABLE IN THE SAME SERIE

Recorded Event: October 20, 2021 - Online Event



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