Reduce Human Error on the Drug and Device Manufacturing Floor

Reduce Human Error on the Drug and Device Manufacturing Floor:
Framework and Tools to Assure Effective CAPAs
**FDAnews Webinar**
June 29, 2015 — 1:30 p.m. – 3:00 p.m. EDT

What causes drug and device manufacturing failures and recalls? Human error. Time after time, CAPA investigations single it out as the root cause of violations.

If there were a magic formula for ending human error, we’d share it. But here’s the next best thing, systematic best practices and strategies that have been proven to cut human error and boost success on the factory floor. In many cases, firms have seen error reductions of 50% in less than one year.

Learn them in half an afternoon. Log on Wednesday, June 29, and discover the new management science of human error reduction in drug, biologics and device manufacturing.

The webinar leader is Ginette Collazzo, Ph.D., an authority on industrial/organizational psychology boasting more than 15 years’ experience with major drug and device makers, including Bristol-Myers Squibb, J&J, Schering-Plough and Wyeth, Parexel, Perrigo, and Cephalon Pharma.

She has recently developed new tools to measure, explain and predict human error from both process and cognitive load perspectives. And she’ll demonstrate her newly created tools for improving systems and processes, staff training and reducing human error:

  •     Process-related prediction tool: This tool allows organizations to identify cracks and concerns that are based on their organizational processes. 80% of mistakes are caused by problems within these systemic areas:

o    Procedures
o    Human factors engineering
o    Training
o    Communication
o    Supervision

  •     Cognitive load assessment tool: Only 20% of mistakes occur due to human frailties. This tool examines best practices for restructuring training and processes to improve workers’ ability to perform as expected. The tool focuses on workers’:

o    Individual performance
o    Memory
o    Attention
o    Problem solving
o    Calculating
o    Reasoning
o    And decision making
Even more, she’ll map 4 best practices for determining the scope of problems:

1)    Diagnose — How to re-analyze failure investigations for the preceding
12 months
2)    Categorize and Code — How to sort investigations into 4 levels
3)    Quantify — How to determine which level to tackle first and which can wait
4)    Plan Based on Priorities — Taking the GUT check (Gravity, Urgency and Tendency) to set training priorities

Attendees will learn these specifics:

  •     How to start an error-reduction program, then measure its effectiveness
  •     Identifying the relationship between CAPA and human reliability and performance expectations
  •     5 key elements of an effective human error CAPA system — essential system safeguards
  •     Unlocking the mystery of root cause analysis and human error
  •     Revealing destructive human behavior factors and creating effective recommendations to modify them
  •     Why existing practices fail, “correctives” that don’t correct, “preventives” that don’t prevent
  •     Trending and tracking, assuring that improvement is by design, not chance
  •     And more!

Forget the band-aid approach. Learn methods and models that are proven to cut human error by half and even more.

Who Will Benefit:

  •     Training managers and coordinators
  •     Operations
  •     Manufacturing
  •     Plant engineering
  •     QA/QC staff
  •     Process excellence/improvement professionals
  •     Industrial/process engineers
  •     Compliance officers
  •     Regulatory/legislative affairs professionals
  •     General/corporate counsel
  •     Executive management

Meet the Instructor:
Ginette Collazo Ph.D. has spent more than 15 years in technical training, organizational development and human reliability for Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough and Wyeth. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics.

Conference Details:
Reduce Human Error on the Drug and Device Manufacturing Floor:
Framework and Tools to Assure Effective CAPAs
**FDAnews Webinar**
June 29, 2015 — 1:30 p.m. – 3:00 p.m. EDT

$287 per site

Easy Ways to Register:
Online: http://
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.


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