Description
<strong>Course Schedule - Pre-recorded Course</strong><br/><br/>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.
<br><br>
<b>Module 1:</b><ul><li>
Background-Regulatory Requirements</li>
<li>Key Definitions: what is a complaint, anyway?</li>
<li>What needs to be in my complaint procedure?</li></ul>
<b>Module 2:</b><ul><li>
Complaint Receipt</li>
<li>Complaint Review: Is it an MDR?</li>
<li>Complaint Investigations; so, why did it fail anyway?</li></ul>
<b>Module 3:</b><ul><li>
Do I need to take Corrective Action?</li>
<li>Can I close this complaint already?</li>
<li>What is Complaint Trending and why do I need to do it?</li>
<li>Resources, Record-keeping, and other Essentials</li></ul>
01/13/2009
To
01/01/0001
Training Company
The Center for Professional Advancement (CfPA)
Industry
Biotech
Course Category
Brochure Name
http://www.cfpa.com/PDF/2007/2132,C7-048,0704-409.pdf
Address
AN ONLINE TRAINING FORMAT On-Demand Training