Why Understanding How to Manage Human Error and Apply Human Factors is Critical to Achieving Effective Corrective Actions/Preventive Actions (CAPA)

Duration: 90 Minutes
Ineffective CAPA(s) results from a continued use of misleading approaches to conducting investigations, such as, root cause analysis instead of Causal Analysis. Causal Analysis provides an understanding of all contributing factors to a deviation. There is never just one cause for a deviation; therefore, root cause analysis doesn't provide the necessary data for a deviation to determine all needed CAPA(s). Furthermore, to ensure effective CAPA(s) are implemented requires understanding the science behind human system interaction, how to human factor systems and manage human error and a formal process to measure CAPA effectiveness must be a part of a quality system.
How to Manage Human Error
Instructor: Amy M. Peterson
Product ID: 501349
Failure is the "gold mine" for the opportunity to learn and improve. Consider what I heard in a presentation by a Duke University, Civil Engineer professor on the benefits of failure, "If the Titanic had gone a little slower or faster and hadn't hit the iceberg, causing such a tragedy, how many more steel ships would have been built with the same structural flaw?"

Objectives of the Presentation
  • Be able to use a proven risk and science based approach to complete causal analysis
  • Ways to mitigate human error through understanding human-system interaction (Human Factors)
  • What types of changes need to be made to quality systems to complete causal analysis, implement and monitor CAPA effectiveness
  • How to evaluate aspects of culture that are preventing the opportunity to learn from failure so CAPA effectiveness is achieved
  • How do quality system process changes to achieve effective CAPA impact quality system software changes
  • Create a shared responsibility culture that supports learning from failure in order to advance quality
Why Should you Attend
Ineffective Corrective Action/Preventive Action (CAPA) systems have been noted repeatedly by regulatory agencies, particularly by the FDA as a significant quality system weakness.
Ineffective CAPA leads to:
  • Poor quality; repetitive quality deviations
  • Product Recalls: Product Complaints
  • Inefficiency
  • Financial loss
  • Employee frustration/reduced morale
  • Employee turnover
Areas Covered
Key effective CAPA components:
  • Regulatory compliant system
  • Electronically compliant system with ability to monitor adverse trends (accessing data is crucial because you can't fix what you don't know about)
  • Data / interview process of investigation (timing, culture)
  • Risk assessment
  • Human error management: understand conditions that promote human error / error prevention techniques
  • Human Factors: human-system interaction (equipment, standard operating procedures (SOP), Forms and more)
  • Causal Analysis (not Root Cause Analysis)
Who can Benefit
  • CEO
  • Quality President
  • Quality Vice President
  • FDA Auditor
  • Quality Auditor
  • Sr. Quality Director
  • Quality Director
  • Compliance Officer
  • Quality Manager
  • Quality Specialist (any level)
  • HR Director
  • HR Manager
  • Quality System Software Validation Director
  • Software Validation Director
$300
Recorded Session for one participant
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Instructor Profile:
Amy M. Peterson, MS is a quality leader with 22 years of experience, designing, enhancing, remediating, implementing and managing award-winning robust, risk-based Food and Drug Administration (FDA) compliant quality systems in pharmaceutical, biotechnology, and medical device industries.

GOAL:
She is dedicated to relentlessly influencing and educating industry leaders and regulators on understanding how to raise quality standards to ensure consumers receive quality products.

RELATED EXPERIENCE:
Experienced at integrating proven techniques and tools from different industries into quality systems to achieve tremendous continuous improvement results; multi-billion dollar cost savings:
  • Implementing effective corrective action(s) and preventive action(s) (CAPA)
  • Increasing process efficiencies by >26%
  • Decreasing deviation rates by >86%
  • Deploying concepts, tools and techniques to manage human error, which have been proven successful for 20+ years in North America Commercial Nuclear
  • Human factoring controlled documents and processes
  • Training and implementing proven methodology to achieve procedural (SOP) adherence
EDUCATION:
  • Bachelors in Chemistry from North Carolina State University (NCSU)
  • Masters in Human Nutrition from East Carolina University (ECU)
  • CURRENTLY earning Masters in Regulatory Science from Johns Hopkins University (JHU) [2016 to 2018]
Masters in Regulatory Science
The MS in Regulatory Science from Johns Hopkins University (JHU); curriculum developed through collaboration with the Food and Drug Administration (FDA) and includes lectures by both esteemed JHU professors and FDA staff.

AUTHOR/PHILANTHROPIC WORK:
Additionally, she is embarking on a personal and professional journey, authoring a book:
"I Have What?" A True Story of Being Diagnosed with a Rare Disease
In memory of my late and dearest best friend, whose wish was for her experience to be shared with others to raise awareness about how and where to get help when diagnosed with a rare disease.
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