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/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"
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 results 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.