Effective Risk-Based CAPA Investigations Based on the New GHTF Guidance Document

Having a solid understanding of the overall process and techniques used to support your organization’s corrective and preventive action (CAPA) system is important for regulatory compliance and business success.  This webinar addresses the industry’s need for further education on how to identify and investigate root causes and effectively implement solutions for corrective and preventive actions.

Program content includes an overview of the current regulatory requirements and the new draft Global Harmonization Task Force (GHTF) Guidance on corrective action and preventive action and related QMS processes.  There is a discussion on the systems your organization needs to have in place to satisfy FDA’s Quality System regulation.  The webinar also:

PROGRAM OBJECTIVES

The program illustrates straight-forward approaches to effective CAPA management and how to overcome the typical obstacles that stand in the way of an effective and efficient CAPA system.  Speakers go beyond the regulation to educate industry on how to apply these approaches within your organization’s everyday work.  Participants will learn what tools, techniques, and methodologies are important within a CAPA system.  At the conclusion of the webinar, participants will gain an appreciation of corrective and preventive action techniques used to support a quality system and be able to utilize these tools to add value to their organization.

  PROGRAM-AT-A-GLANCE
 
  • Planning
    • Establishing sources of quality data
    • Risk control and risk mitigation outputs
  • Measurement and Analysis of Data
    • Practical approach to escalating issues to CAPA
    • Measurement and analysis of data
  • A Phase-Based CAPA System
    • Advantages
    • Four phases described in the GHTF guidance
  • Investigation Process
    • Investigation of the reported nonconformity
    • In-depth root cause analysis
    • Identification of appropriate actions
    • Verification of identified actions
    • Implementation of actions
  • Determining the Effectiveness of your CAPAs
    • Eliminating recurrences and overcoming obstacles
    • Benefits of a strong CAPA system
  • Question & Answer Session

SPEAKERS

WHO SHOULD PURCHASE

The webinar is designed for quality and regulatory compliance experts, device risk managers, software developers, and validation professionals.

WEBINAR CD

Webinar CD — Includes pdf of handout materials and webinar recording on CD. 

Please note: Domestic and international shipping rates apply.

WAYS TO PURCHASE

  1. Phone - 1-800-373-3174 to order with a credit card.
  2. Fax - Select and download the order form and fax to 240-396-5781.
  3. Mail - Select and download the order form and mail with payment to:

    Webinar CD
    PO Box 0211
    Annapolis Junction, MD 20701-0211

QUESTIONS?
For questions about ordering the CD, please contact Publications at 1-877-249-8226 or 240-646-7031. For content questions, please contact Jeanine Beisel at 703-525-4890, ext. 1212.