CAPA – The Heart of Your Quality System

Pre-Recorded CD Webinar
Approximately 90 minutes in length, Self Examination and Answer Key Included

Who Will Benefit
This training solution will benefit professionals in the following industries:

“Medical Device, Pharmaceutical, Human Tissue, Biotechnology”

In departments such as:
“QA/QC/RA, Manufacturing/Operations, Research and Development, Legal”

With job functions:
“Department managers and supervisors, QA/QC/RA specialists and engineers, Manufacturing and R&D engineers, chemists, scientists, formulators, documentation specialists, auditors, technicians”

Description
CAPA systems have come under intense scrutiny by the FDA in recent years. This course will examine the current industry-FDA environment and will give you tools for survival; it will provide a step-by-step guide to the setting-up, operation, management and auditing of a CAPA system for today’s FDA regulated industry environment.

  • Section 1:
    • Background-Regulatory Requirements
    • Why do I need a CAPA System?
    • Why is CAPA the “Heart” of my Quality System?
  • Section 2:
    • What exactly is a CAPA System and what is it supposed to do?
    • What are the Essential Elements of an effective CAPA System?
  • Section 3:
    • How do I implement an effective CAPA System?
    • Why all these records; is there an easier way?
    • How can computer automation help?


Order On-Line to Own This CD Webinar: $195.00