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)
If you want to enroll please send an email to firstname.lastname@example.org. Once we have the names we will send you a registration form for payment. We accept credit card, ATH and checks.
Ginette M Collazo, LLC.
Metro Office Park, Conference Room
Metro Parque 7, Street 1
Guaynabo, San Juan, 00968
$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.
> 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
- Human error rate
- 1st time pass rate
- Overall equipment effectiveness (OEE)
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