SPONSORED BY:  FDAnews and Ginette M Collazo, Inc.

DATE:  September 16 and 17, 2014

TIME:  Day 1–8:30 am – 4:30 pm; Day 2–8:30 am – 5:00 pm

Location:  Marriott Raleigh Crabtree Valley, 4500 Marriott Drive, Raleigh, NC  27612

Cost:  $1,797 per person (Team Discounts Available) includes the 2-day workshop, all workshop materials, continental breakfast and lunch each day.  ASQ Raleigh members will receive a 15% DISCOUNT off the full registration price if they use the Promotional Code ASQ1113.

Online Registration Link:  DrugDeviceErrors


FDAnews  and Dr. Ginette Collazo — a 15 year veteran of helping drug, biologic and device firms reduce manufacturing errors by 50 percent or more — will conduct a one-of-a-kind workshop that teaches quality managers and manufacturing excellence professionals how to reduce errors and improve quality metrics.

Next Tuesday and Wednesday (Sept. 16-17) join us at the Marriott Raleigh Crabtree Valley as you’ll learn how small improvements in both manufacturing systems and improved employee training can deliver big results.  Dr. Collazo recently worked with a drug manufacturer that had a baseline rate of 4.7 errors per thousand units manufactured. But with effective human error reduction strategies, the error rate was reduced to 1.9.  A 60% reduction achieved in just 10 months.

ASQ Raleigh members will receive a 15% discount off the full registration price if they use the Promotional Code ASQ1113.

Limited seating available at this time.  Act now.

This 2-day interactive workshop you will teach you:

  • How to understand the implications of human error events — how they affect product quality, business operations and regulatory compliance
  • Best practices for diagnosing your error tolerance, how to get an error reduction program started and how to measure its effectiveness
  • How to identify the relationship between CAPA and human reliability and performance expectations
  • Destructive human behavior factors and how to create the effective recommendations to modify them
  • 5 key elements of an effective human error CAPA system — strategies to address essential system safeguards that must be put in place to prevent and correct problems
  • How to unlock the mystery of root cause analysis and human error
  • How to understand key obstacles in existing practices — why correctives don’t correct, and preventives don’t prevent
  • Trending and tracking — how to assure that improvement is not by chance but by design
  • Insights into how to leap past hurdles and predict errors

GINETTE COLLAZO, PH.D., has spent more than 15 years in technical training, organizational development and human reliability. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth and Medtronic, and many more small and mid-sized drug and device companies. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics.


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