Course offering number:1202-703
Course ID:
2492
Equipment Qualification 1.0
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This online training will benefit professionals in the following industries: Pharmaceutical, Biotechnology, and Medical Device.
In departments such as:
QA/QC/RA, Manufacturing/Operation, Research and Development, Legal, Engineering
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 and is undergoing a significant change by the application of
the Quality Risk Management principles described in ICH Q9. This 90-minute accredited online training course will examine the new
industry/FDA QRM 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 conduct and document qualification (verification), handle deviations, prepare summary reports
and “maintain the qualified state”.
Further, this course provides “content understanding” so important for auditing qualification activities as required in today’s FDA QRM regulated
industry environment.
Review of Learning Objectives
Module 1:
• Background-Regulatory Requirements
• Why do I need to qualify equipment?
• What is equipment qualification?
Module 2:
• Qualification Basics; QRM based approaches
• Execution and Documentation Basics
Module 3:
• Handling Deviations
• Summary Reports
• When do I need to do all this?
• How do I “maintain the qualified state?” and lifecycle
implications
Question and Answer Session