The Center for Professional Advancement, Your Computer
September 6, 2007
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
|
|