Deviation Management - Investigations to Root Cause Analysis

Why Should You Attend:

This webinar will teach you how to perform a good investigation, how to perform good root cause analysis, develop appropriate actions to eliminate each root cause, and the steps to perform to implement the identified actions.

Topics will include investigational tools such as interviewing (it’s not interrogation), record review (what am I looking for?), inspection, observation, and simulations, various root cause analysis tools – what are they and when do I use them. Topics will also include tools for identifying and implementing actions to eliminate the root cause.

Ultimately, you also need to assemble the documentation to tell your story. This webinar will conclude with some key pointers in telling the story.

Failures in investigations and root cause analysis have been in the top five of compliance observations for over thirty years. Fundamental in these observations are that companies have failed to uncover the true root cause of problems encountered, too often settling on symptoms, such as human error. The net result is that problems continue to recur, products are released to the field with one of more issues and patients are put at risk. Additionally, businesses are adversely impacted due to responding to warning letters, managing complaints and product recalls.

Although there are numerous seminars available, most focus on root cause investigations – investigating to get to root cause. More often than not, this approach does nothing more than reinforce preexisting opinions on what we think is going on, rather than gathering facts of what specifically happened in this instance. This presentation describes the tools and techniques for performing good investigations, identifying true root causes and for implementing corrective actions.

Areas Covered in the Webinar:

• Investigation Steps
• Interviewing
• Record Review
• Product/Material inspection
• Equipment / Facility Inspection
• Operation Observation
• Simulations
• Root Cause analysis tools
• Brainstorm
• Cause and Effect Diagrams
• 5 Whys
• Comparison
• Corrective action tools
• Nominal Voting
• Matrix Analysis
• Affinity Diagram
• Implementation

Who Will Benefit:

• All personnel engaged in managing and executing deviation investigations. Also appropriate for new students who have basic familiarity with the regulations related to deviations and CAPA.
• All members of regulated industry involved in managing deviations and ensuring problems are fixed such that they do not recur.

David Husman
President and Principal Consultant, David Husman Consulting LLC

Over 30 years of diverse international industry experience in Quality Assurance, Quality Control and Regulatory Affairs. Last 18 years as a consultant to biopharma, pharma and device industries.

Experience has spanned from R&D to Commercial Manufacture

Background includes, but not limited to, parenteral products, human tissue products, blood products, biotech products, solid dosage, vaccines, implantable devices, and in vitro diagnostic products for both human and animal species.

Extensive experience in laboratory operations including but not limited to auditing, development of laboratory system procedures, implementation of laboratory at a new site and forensic data integrity investigations.

Experience in all parts of the manufacturing operation from warehousing to packaging, from facilities and utilities to laboratories to computer systems, from regulatory to quality control.

Expert level in Compliance and Quality System development.

Executed numerous Data Integrity assessments and remediation projects worldwide.

Ph.D. in Biochemistry, Certified as a GMP expert and in Regulatory Affairs.

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