Boston Professional Events List


3-Hour Virtual Seminar on CAPA for Medical Devices


Date
Sep 18, 2019 - 01:00 PM - 04:00 PM
Organizer
WCS
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4 ,Hollywood, FL 33021,

Hollywood,
FL,
US,
ZIP: 33021
Phone: 844-267-7299 | 954-947-5671  

Session Session Highlights

  • FDA and NB expectations for CAPA

  • Lessons Learned from 483s and warning letters

  • CAPA Process

  • Common problems CAPA

  • How to structure your CAPA process for effectiveness and efficiency

  • 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

Why should you Attend

CAPA is the cornerstone of an effective Quality Management System. Yet, it frequently perceived as a burdensome and bureaucratic exercise. Many companies struggle to establish and maintain a CAPA program that is efficient and effective. An ineffective CAPA System leads to disastrous consequences such as medical device reports, recalls, 483s, and warning letters. And an inefficient CAPA program results in wasted time, money, and missed opportunities. In this webinar, we'll discuss the fundamentals of a CAPA program and how you can make your CAPA program more efficient and more effective.

Learning Objectives:

  • Understand the regulatory requirements

  • Creating an efficient and effective process

  • 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

  • Internal Auditors and Managers

  • Training Specialists

  • CAPA Specialists

  • 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

    Overview

    This 180-minute webinar will focus on how to improve your CAPA process to optimize efficiency and effectiveness, 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.

    CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. This 3-hour webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. Learn how to avoid common problems and establish an efficient and effective CAPA 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. In this 3-hour webinar, 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.

     



Speaker Details


Speaker Profile

Susanne Manz ,MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma.

Wcs Seminars
Registration Details
(Contact us : 844-267-7299 | 954-947-5671  
Don't wait. Register TODAY or  Email  US [email protected]
 


Event Categories
Keywords: pharmaceutical




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