Complaint Systems – The Essential Requirements 2013

Topics

• Key Definitions: what is a complaint, anyway?
• Background-Regulatory Requirements
• Complaint Receipt
• What needs to be in my complaint procedure?
• Complaint Investigations; so, why did it fail anyway?
• Complaint Review: Is it an Adverse Event?
• Can I close this complaint already?
• Do I need to take Corrective Action?
• Resources, Record-keeping, and other Essentials
• What is Complaint Trending and why do I need to do it?

Who should Attend

Professionals from

• Pharmaceutical
• Medical Device
• Biotechnology
• Human Tissue

involved in:

• Manufacturing/Operations
• QA/QC/RA
• Legal
• Research and Development