Course offering number:0711-717
Course ID:
2132
Complaint Systems - The Essential Requirements
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/Operations, 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
Complaint Systems have 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 the essential requirements
of a Complaint System including setting-up, operating, and managing the system for today’s FDA regulated industry
environment. Further, this course provides “content understanding” so important when auditing Complaint Systems.
Module 1:
Background-Regulatory Requirements
Key Definitions: what is a complaint, anyway?
What needs to be in my complaint procedure?
Module 2:
Complaint Receipt
Complaint Review: Is it an MDR?
Complaint Investigations; so, why did it fail anyway?
Module 3:
Do I need to take Corrective Action?
Can I close this complaint already?
What is Complaint Trending and why do I need to do it?
Resources, Record-keeping, and other Essentials