Reduce Human Error on the Drug and Device Manufacturing Floor Assure Effective CAPAs

Held Oct. 25, 2011

Human error causes 80% of drug and device manufacturing failures, studies indicate.

To uncover the secrets of reducing human error, improving your products and fending off the FDA, read on ...

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.

Learn them yourself — in half an afternoon.

This is your invitation to log on Tuesday, Oct. 25, and discover the management science of human-error reduction in drug and device manufacturing.

Your webinar leader is Ginette Collazzo, Ph.D., an authority on industrial/organizational psychology boasting more than 10 years’ experience with major drugmakers, including Bristol-Myers Squibb, J&J, Schering-Plough and Wyeth.

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

And she’ll demonstrate a 5-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

You’ll 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!

The webinar is convenient to attend. All that’s required is that you be in front of a computer monitor at the appointed time, whether you’re at the office or telecommuting from your office-in-home.

Of course, Dr. Collazo 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 CAPA will benefit from taking part in this event — and they can do so at a cost that won’t break the budget. You pay a single low registration fee per facility, regardless of how many participate. So spread the word.

Forget the band-aid approach. Learn methods and models that are proven to cut human error by half — and even more. Sign up for Reduce Human Error on the Drug and Device Manufacturing Floor today.

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

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

Ginette Collazo, Ph.D. 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.

Order now!