Root Cause Analysis - Webinar CD/Transcript
Root Cause Analysis: Right the First Time
Under the FDA’s risk-based requirements, every company doing business in the medical products industry, including suppliers, must have a corrective and preventive action (CAPA) program. The most essential component of which is a documented system for discovering the root cause of system failures, nonconformances, product complaints, and inspection findings.
The bottom line is that your root cause analysis should identify why things go wrong…then make sure they don’t happen again.
But the FDA doesn’t teach you how to do this — you’re on your own to figure out the answers to such questions as:
- When is a root cause analysis necessary?
- What data should you gather, and whose help do you need?
- How do you check that your changes are effective?
- How will you prove it to regulators?
Join industry expert Ronald Schoengold as he provides the answers to those questions and more. He’ll provide you with root cause analysis tools like forms, checklists, and progress charts, along with practical examples to illustrate the process.
In 90 minutes you’ll learn about roles and responsibilities, how to gain management support, and how to prevent 483s, warning letters, and recalls — information which is essential for solving problems and safeguarding your bottom line.
At the end of this presentation you’ll be able to minimize difficulties in fixing problems so that you’ll get it right the first time and to the FDA’s satisfaction. Otherwise you’ll lose time, money and your reputation.