The Center for Professional Advancement, Your Computer - (AN ONLINE TRAINING FORMAT)
August 2, 2007
Who Should Attend:
This online training will benefit professionals in the following industries: Medical Device, Pharmaceutical, Human Tissue, BiotechnologyIn 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-bystep 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?
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