Root Cause Analysis Understand Failures, Exceptions and Nonconformances

Held Aug. 31, 2011

Learn what the FDA doesn’t teach you ... about CAPA and “root cause” compliance.

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.

  • QA/QC managers
  • Regulatory affairs specialists
  • Facility managers and engineers
  • Operations/maintenance specialists
  • Reliability specialists
  • Environmental and safety officers
  • Design engineers

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Michele Piepoli, Managing Director of MHP Consultants, LLC, a consulting organization with emphasis in the pharmaceutical industry, Ms. Piepoli has led domestic and international projects ensuring completion of regulatory commitments. Areas of expertise include quality/compliance, laboratory operations and excellence, and process improvement. 

Skilled at developing and presenting compliance training seminars, conducting facility audits and playing a key role in the development and implementation of quality systems, she has been instrumental in providing recommendations and leading projects for the remediation of critical health authority findings.

Ms. Piepoli has led efforts to improve the quality of non-conformance/deviation (laboratory and nonlaboratory) investigations resulting in significant deviation reduction.

As Director of Shuster Laboratories, Inc., Pharmaceutical Division, Atlanta, Georgia, Ms. Piepoli was responsible for the fiscal and technical operations, as well as assuring full regulatory compliance of the Atlanta facility. Prior to joining Shuster, she served in positions of increasing responsibility in the contract laboratory industry.

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