Course offering number:0801-729
Course ID:
2124
CAPA - The Heart of Your Quality System
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This online training 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.
Module 1:
Background-Regulatory Requirements
Why do I need a CAPA System?
Why is CAPA the “Heart” of my Quality System?
Module 2:
What exactly is a CAPA System and what is it supposed to do?
What are the Essential Elements of an effective CAPA System?
Module 3:
How do I implement an effective CAPA System?
Why all these records; is there an easier way?
How can computer automation help?