Course offering number:0711-720
Course ID:
2135
Equipment Qualification in a Nutshell
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/Operation, 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
Equipment Qualification has 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 planning and preparing for equipment qualification and includes a discussion of how to write qualification protocols, handle deviations, report qualification reports and “maintain the qualified state”.
Further, this course provides “content understanding” so important for auditing qualification activities as
required in today’s FDA regulated industry environment.
Module 1:
Background-Regulatory Requirements
Why do I need to qualify equipment?
What is equipment qualification?
Module 2:
Qualification Basics
Protocol Basics
Module 3:
Handling Deviations
Qualification Reports
When do I need to do all this?
How do I “maintain the qualified state” and what does that mean, anyway?