Root Cause Analysis Understand Failures, Exceptions and Nonconformances
Product Details
The FDA requires you to comply with risk-based CAPA by creating documented systems for discovering the root cause of system failures, process exceptions and nonconformances.
Your root cause analysis should identify why things go wrong … then make sure they don’t happen again.
But the FDA doesn’t teach youhow to do a root cause analysis.
That’s where we come in.
Now you can learn the fundamentals from a veteran consultant who has reviewed hundreds of failure investigations. Michele Piepoli, president of MHP Consultants, walks you through:
- Steps to contain and assess product risk
- How to determine when a root cause analysis is necessary
- Who should be on your investigation team
- 3 tools for performing root cause analyses
- Avoiding the most common errors in root cause analysis
- Which data to gather (and which are not important)
- Tracking and trending “document and correct” errors
- Documenting investigation results and recommendations
- And much more
In 90 information-packed minutes, you’ll participate in a hands-on training on how to investigate training deficiencies, and take away proven root cause analysis methods including:
- The “5 Whys” Technique
- Kepner Tregoe (KT) Techniques
- Cause and Effect (Fishbone) Diagram
This is the perfect opportunity for you to learn from your failures and nonconformances — all in this interactive 90-minute session.
A Treasure-Trove of Free Bonuses
Each registered site will also receive:
- A high-level root cause and CAPA process flow diagram
- Four categories of product impact risk chart
- “4 M” Fishbone Diagram to guide investigation questions
and ensure all possible causes are explored
The Root Cause Analysis webinar is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you’re at the office or telecommuting from your office-in-home.
Of course, Ms. Piepoli will be on hand to answer all of your questions. Simply submit your questions via email, and you’ll have answers by the time the session ends.
Everyone in your organization with a role in root cause analysis will benefit from taking part in this event — and they can do so at a cost that won’t break your budget. You pay a single low registration fee per facility, regardless of how many participate. So spread the word.