Course Description:

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 behaviour CAN be manipulated reducing the likelihood of these occurrences. To work with these challenges it is really important to understand human behaviour 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 correct, prevent and avoid re-occurrence of these issues.

Learning Objectives:

  • Understand human error: factors and causes.
  • Understand the importance: regulatory and business.
  • Define the process to manage Human Error deviations.
  • Identify Root Causes associated to human error deviations.
  • Identify what I can do to support human reliability.

Seminar Fee Includes:

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

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?
  • Common mistakes: Memory failures, Overconfidence, We believe we are above average, Visual Detection, Vigilance Effectiveness.
  • Types of error
  • Human error rates and measurement
  • Trending and tracking
  • Prediction
  • CAPA effectiveness

Who will Benefit:

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

Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:00 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

9:00 a.m. – 10:00 a.m. How to write error free procedures.

  • Introduction.
  • Human error basics.
  • Background and best practices in other industries.
  • Human error vision, error types and initial classification.
  • Human error taxonomy, framework and methodology.
  • Human error cause categories.
  • Performance shaping factors associated to procedures

10:00 a.m. – 10:15 a.m. BREAK

10:15 a.m. – 12:00 p.m.
Procedures and regulations- The importance for human error prevention, training and other uses.

  • The purpose of procedures and the importance for human error prevention.
  • Regulatory compliance background and agencies’ expectations for procedures. Importance of procedures.
  • Universal purpose of procedures: training, execution, and troubleshooting.
  • The Human perspective and instructions writing: how do we understand written instructions?
  • Procedures as a root cause: when, how and why do we categorize procedures as a root cause? Why resistance to procedures?
  • Documentation hierarchy: from policies to record documents, documentation levels and level of detail.

12:00 p.m. – 1:00 p.m. LUNCH

1:00 p.m. – 2:30 p.m. The Human perspective

  • The thinking and reading process.
  • The human brain and errors of interpretation.
  • Cognitive process and impact in manufacturing execution.
  • Perception and understanding.
  • Brain function and instructions development.
  • Human thinking model: how we react to stimuli and process information.
  • Rule based behavior and skill based behavior: impact on execution.
  • Common mistakes and causes found in the industry.

2:30 p.m. – 4:30 p.m. How to create and maintain procedures.

  • Facts about effective procedures.
  • How to accomplish procedures main goal?
  • Six step process:
    • plan,
    • investigate,
    • organize,
    • draft,
    • draft revision,
    • validation (field test),
    • Maintenance

8:30 a.m. – 10:00 a.m. Human Engineering Procedures

  • Discussion of insights from Day 1
  • Writing rules and content development.
  • Writing steps, sub-steps, and conditional statements.
  • Page format: Font size, spacing, use of white space, title structure, control features, and other requirements.

Practice writing steps, sub-steps and conditional statements.

10:00 a.m. – 10:15 a.m. BREAK

10:15 a.m. – 12:00 p.m. Human Engineering Procedures (cont.)

  • Procedure styles
  • Format styles: when to use which?
  • Making sure procedures are complete: what-if analysis and FMEA.
  • Electronic vs. Paper based procedures: advantages and disadvantages.
  • Validation and field testing steps.
  • Procedure maintenance and change management.
  • Document configuration and control system

Practice: evaluate your procedure and suggest changes. Group discussion.

12:00 p.m. – 1:00 p.m. LUNCH

1:00 p.m. – 2:30 p.m. Human error deviations related to procedures.

  • Root cause analysis.
  • Procedure related near root causes and root causes.
  • CA-PA and procedures: be very careful.
  • Process vs. procedure assessment.
  • 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.
  • How to avoid deviations related to procedures.

2:30 p.m. – 2:45 p.m. BREAK

2:45 p.m. – 3:45 p.m Writing recommendations and final thought on metrics.

  • High end and low end recommendations.
  • KPI’s
  • Human error rate
  • 1st time pass rate
  • Trending
  • Tracking

3:45 p.m. – 4:00 p.m. Review and Key Insights Materials

Meet Your Instructor

Ginette M Collazo
Industrial/Organizational Psychologist at Ginette M. Collazo

GINETTE COLLAZO, PH.D is a human error and human behavior expert. She has spent more than 15 years in technical training, organizational development and human reliability areas. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth, and has been a consultant with major firms like Abbott, Johnson & Johnson, Perrigo, among many others. Also has implemented human error reduction programs and technology in 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.

Register Now

Online using Credit card

Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]

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),
6201 America Center Drive Suite 240
San Jose, CA 95002

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 @ [email protected]

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.

Media Partners


Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.

Media Partner To Do
  • Banner (min 728x90 or 468x60) on the media partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the magazine and/or website.
  • Dedicated email blast to media partner’s subscribers.
  • Article on the magazine and/or website after the conference.

Local Attractions

The New Jersey Performing Arts Center (NJPAC) has garnered national attention during its first 11 seasons, serving as a model for programming, audience diversity, education initiatives and the catalytic role it has played in returning nightlife and economic activity to NJ's largest urban community.

The facility, initially served the needs of the New Jersey Symphony Orchestra, the New Jersey State Opera and other state dance and theater companies. In addition to that, NJPAC routinely hosts national and international performers plus touring companies and has become a world-class entertainment destination.

The Newark Museum in Newark, the state's largest city, offers outstanding collections, exhibitions, programs and educational resources in its multibuilding campus in the heart of Newark’s Downtown/Arts District.

Founded in 1909, the Newark Museum underwent an extensive four-year, $23 million renovation and expansion program, which was completed in 1989. The design, by world-famous architect Michael Graves, garnered the American Institute of Architects’ Honor Award. The museum complex weaves together 80 galleries of art and science, a miniature zoo, planetarium, gift shops, café, auditorium, sculpture garden, schoolhouse and the Ballantine House, a restored 1885 mansion that is a National Historic Landmark.

Dining defines The Ironbound District as a culinary experience par excellence. It's an adventure enriched by quality service, cultural authenticity and delicious infinite variety. Visitors can choose from the District's more than 170 restaurants and eateries that serve lunch or dinner in an excursion into world-class international cuisine.

Predominantly Portuguese, Spanish and Brazilian, flavored by Mexican and Central and South American influences, the district also offers an abundance of fresh seafood, a scintillating selection of meat and chicken dishes and regional favorites are served up in generous portions and at affordable prices.

French Gothic cathedral famous for its stained glass. Organ recitals.

The park's more than 2,000 cherry trees exceed both the variety and number found in Washington, D.C., Each spring, the park is home to the annual Cherry Blossom Festival. Branch Brook Park is the first county park to be opened for public use in the United States.

We need below information to serve you better



6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube


Copyright © 2023 MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method