Reducing Human Error in GMP Environments: Assure compliance with regulators expectations

 2-day Course. 

This is an exclusive event in Puerto Rico and there will be only 10 spaces available.

DATE & TIME:
September 15 -16
9:00am – 4:00pm (with lunch break at 12:00)

REGISTRATION:
If you want to enroll please send an email to marisol@ginettemcollazo.com. Once we have the names we will send you a registration form for payment. We accept credit card, ATH and checks.

LOCATION:
Ginette M Collazo, LLC.
Metro Office Park, Conference Room
Metro Parque 7, Street 1
Suite 204
Guaynabo, San Juan, 00968

COST:
$1,500.00 per person: Includes electronic material, parking, breaks and lunch.

TERMS AND CONDITIONS:
– Training course registrations will not be confirmed until registration is complete and payment is received in full or a PO is received.
– Cancellations will have a 250.00 fee.
– No shows will be charged in full.
– We accept all credit cards.

AGENDA:
> Day 1

Understanding the Basics of Human Error On the Manufacturing Floor

  • How human errors intersect with manufacturing regulations.
  • Examples of applicable FDA requirements and what the FDA expects companies to be complying with.
  • A review of other industry standards that apply to drug and device manufacturing.
  • What FDA investigators look for during inspections and the most common violations found in Form 483s and Warning Letters.
  • Which violations tied to human errors and manufacturing are trending up.
  • The various types of human errors commonly found on manufacturing floors.
  • How we got here — why human error reduction is such an important topic.

Human Error in Context — What Are the Factors That Drive Human Errors? 

  •  The taxonomy of human error; how and why drug and device companies need to focus on this in their investigation processes.
  •  Why administrative and management systems factor so prominently into deviations and nonconformance.
  •  The role of innovative operational controls and their role in reducing human errors.
  •  Simple procedures that prevent human error — how they should be described and presented to maximize human error reduction.
  •  Common examples of poor human factors, engineering and workplace conditions that contribute to human error.
  •  When training is appropriate and when we should stop.
  •  Learn how common day-to-day communication gaps contribute to human error.
  •  How supervision can be one of the best human error reduction strategies at your site.
  •  When is individual performance responsible for human error and when does it become a root cause.
  •  How to address cognition, attention, and memory failures at your site.

Internal vs. External Factors

  •  How our biology affects our thinking process and individual performance?
  •  Understanding the latest on cognitive load and attention, memory, and decision making errors — how they commonly occur on the manufacturing floor.
  •  How our senses control how we react — it’s more important that you think.
  •  Best practices for controlling human factors for optimum people performance.
  •  How to create an organizational environment that supports human error reduction initiatives — from senior management to floor level staff.
  •  Why our culture with regards to human error has to change; it’s not an easy process but vitally necessary for drug and device companies.

Corrective and Preventive Action (CAPA) — FDA’s #1 Manufacturing Compliance Problem

  •  How to develop corrective actions that make sense —what’s working and not working.
  •  Creating preventive actions that truly prevent; how to stop errors that have not yet happened.
  •  Understanding the human error prediction process and tools.
  •  Prevention and human error control: proven ways to measure improvement and on-going trend analysis.
  •  When to use detection mechanisms instead of preventive mechanisms — the pros and cons of each.
  •  Human error detection and recovery rate — are you really uncovering all the errors within your facilities?
  •  Assuring the FDA your CAPA program is effective and you’ve adequately focused on human error.

> Day 1

Human Error Reduction Techniques

  •  Discussion of insights from Day 1.
  •  When is human error a human resources issue?
  •  How and when to apply engineering controls to correct and prevent human error deviations.
  •  What to do when individual performance is the major contributor.
  •  Human error and documentation: from design, construction, change management and implementation.
  •  Additional contributors for human errors will be discussed.

Human Error Investigations

  •  Human error investigation process defined from beginning to end.
  •  How to gather data in the human error investigation process.
  •  How to perform an effective interview.
  •  Important steps for effective human error investigations.
  •  How to report issues to make sure management listens.

Metrics and Human Error

  •  KPI’s
  •  Human error rate
  •  1st time pass rate
  •  Overall equipment effectiveness (OEE)
  •  Trending
  •  Tracking

Review and Key Insights Materials

  •  Copies of the presentations
  •  Current FDA regulations
  •  Pertinent guidance documents
  •  Articles on human error
  •  Manual tools
  •  Interviewing guide
  •  Report example
  •  Root Cause Determination Tool
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