ComplianceOnline

Dr. Ginette Collazo — a 20-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.

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 Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. To work with these challenges, it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed.

This course offers practical approaches to address human performance issues in GMP related environments by using a specific methodology to investigate, correct, prevent and avoid re-occurrence of these issues.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

We will discuss human error categories, near root causes and root causes for these events. We will discuss latest trends in human error issues in the industry.

Register now and get below documents for FREE:
  • RCDT - Root Cause Determination Tool
  • Interview Guide
  • HE Assessment Template
  • Introduction of Tools Material
  • Additional material

Areas Covered :

  • Background on Human Error Phenomena
  • Importance of Human Error Prevention/reduction
  • Training and human error
  • Facts about human error
  • Human Error as the Root Cause
  • What is Human Error
  • How is Human Error controlled?
    • Types of error
    • Human error rates and measurement
    • Trending and tracking
    • Prediction
    • CAPA effectiveness
  • Common mistakes:
    • Memory failures
    • Overconfidence
    • We believe we are above average
    • Visual Detection, Vigilance Effectiveness

Who Will Benefit:

  • Training managers, personnel
  • coordinators
  • Operations
  • Manufacturing
  • Plant engineering
  • QA/QC
  • Process excellence/ improvement professionals
  • Industrial/process engineers
  • Compliance officers
  • Regulatory/legislative affairs professionals
  • General/corporate counsel
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • Lecture 1: Understanding the Basics of Human Error in Manufacturing
    • 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
  • Break
  • Lecture 2: Human Error and Human Factors
    • 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
    • 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
  • Lunch
  • Lecture 3: Psychology and Human Error
    • 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
  • Break
  • Lecture 4: 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 02(8:30 AM - 4:30 PM)
  • Lecture 5: 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.
  • Break
  • Lecture 6: Human Error Investigation
    • 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
  • Lunch
  • Lecture 7: Root Cause Analysis Tools
    • A brief review of common tools used in determining root cause
    • Hierarchy and use of the root cause determination tool for human error investigations
    • How to perform a cognitive load assessment
    • The interview process and interview techniques for human error root cause analysis.
    • When and how to use the human error prediction tool
    • When to perform a process vs. procedure analysis and why it is so important to do so before establishing procedure revision as a CAPA for human error
  • Break
  • Lecture 8: Metrics and Human Error
    • KPI’s
    • Human error rate
    • 1st time pass rate
    • Overall equipment effectiveness (OEE)
    • Trending
    • Tracking
  • Lecture 9: Review and Key Insights Materials
    • Copies of the presentations
    • Pertinent guidance documents
    • Articles on human error
    • Manual tools
    • Interviewing guide
    • Report example
    • Root Cause Determination Tool
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Ginette M Collazo

Ginette M Collazo
Organizational Psychologist, Ginette M Collazo Inc

Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity.

She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry.

Nine years ago, Dr. Collazo established Human Error Solutions (HES), a Florida based boutique consulting firm, where she has been able to position herself as one of the few Human Error Reduction Experts in the world. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development and effectiveness that has been implemented and proven amongst different industries globally. This scientific method has been applied in critical quality situations and workplace accidents.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

$1,299.00

Seminar One Registration

April 23-24, 2019, Boston, MA
(Registrations till February 25, 2019 - $1299)
(Registrations After February 25, 2019 - $1499)




Early bird seats are limited and based on first-come, first-serve.

The registration fee includes: the workshop; all related course materials; morning tea/coffee on both days.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 E. Bayshore Road Suite 260
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Location:

Boston, MA
(Venue to be announced shortly)

April 23-24, 2019

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We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

Benefits of becoming a Sponsor/Exhibitor/Media Partner:

  • Logo on website, marketing email, branding materials & the registration booth
  • Exhibit Space
  • Free event pass
  • Speaking opportunity
  • Social media campaign

For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

Media Partner:

Media Partner

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Local Attractions of Boston, MA

Boston Public Garden

Boston Public Garden

This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.

Boston Public Library

Boston Public Library

The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).

Fenway Park

Fenway Park

Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.

Museum of Fine Arts

Museum of Fine Arts

Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.

Museum of Science

Museum of Science

The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.

North End

North End

This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.

Old North Church

Old North Church

The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.

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