Pre-Recorded CD Webinar
Approximately 90 minutes in length, Self Examination and Answer Key Included
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.
- Section 1:
- Background-Regulatory Requirements
- Why do I need to qualify equipment?
- What is equipment qualification?
- Section 2:
- Qualification Basics
- Protocol Basics
- Section 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?
Order On-Line to Own This CD Webinar: $195.00