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FDA Compliance

Webinar: “Reducing Human Error on the Manufacturing Floor”

Proven systematic best practices and strategies

Published: Monday, November 23, 2009 - 10:00

(FDAnews: Falls Church, VA) -- Human error causes 80 percent of drug manufacturing failures, studies indicate. Discover secrets of reducing human error, improving your products, and fending off the Food and Drug Administration (FDA)  by attending the FDAnews webinar, “Reducing Human Error on the Manufacturing Floor—Assuring Effective CAPAs,” on Tuesday, Dec. 8, from 1:30 p.m. to 3 p.m. EST. 

Register here. Please mention priority code 09N13 when registering.
To register multiple sites for one dial-in fee, call (888) 838-5578 in the United States or (703) 538-7600 globally, and learn about the special multisite discount.
What causes drug manufacturing failures and recalls? Human error. Time after time, Corrective and preventive action (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.

Your instructor

Your guide for this webinar is Ginette Collazzo, Ph.D., an authority on industrial/organizational psychology. She has spent more than 10 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.

She'll map four best practices for determining the scope of problems:

Diagnosis. How to re-analyze failure investigations for the preceding 12 months
Categorize and code. How to sort investigations into four levels
Quantify. How to determine which level to tackle first and which can wait
Plan based on priorities: gravity, urgency, and tendancy (GUT). Taking the GUT check to set training priorities

And she'll demonstrate a five-point method for improving staff training and reducing human error:

  1. Changing the focus of training from learning to reliability
  2. Challenging training methods constantly
  3. Creating interdisciplinary groups to tackle training problems
  4. Improving specific training—human behavior, instructions development, training methods, investigation processes
  5. Enhancing the depth and breadth of courses and skills aimed at managers and employees

Webinar specifics

  • How to start an error-reduction program, then measure its effectiveness
  • Identifying the relationship between CAPA and human reliability and performance expectations
  • Five 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

It’s a lot of ground to cover in only 90 minutes, but don’t worry—not only will you gain a new perspective on error reduction, but you’ll get answers to all your questions, too. This webinar is totally interactive, with the presenter fielding your questions via e-mail. Now’s the time to start drawing up your list.

Who will benefit

Training managers and coordinators 
Plant engineering
QA/QC staff
Compliance officers
Regulatory/legislative affairs professionals
General/corporate counsel
Executive management


About The Author

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FDA News

FDAnews offers a variety of webinars and audio conferences to keep you and your staff current on today’s most important regulatory, legislative, and business issues. To view a complete list of the topics available, visit www.fdanews.com .