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/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”
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.
- Section 1:
- Background-Regulatory Requirements
- Key Definitions: what is a complaint, anyway?
- What needs to be in my complaint procedure?
- Section 2:
- Complaint Receipt
- Complaint Review: Is it an Adverse Event?
- Complaint Investigations; so, why did it fail anyway?
- Section 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
Complaint Systems – The Essential Requirements