Instructor :
Ginette Collazo

Webinar ID:
11798

• • Is Your GMP Compliance at Risk from Hidden Errors?
  • Are Disorganized Workflows Quietly Driving Your Error Rates Up?
  • Could Supervisory Gaps Be Repeating Costly Mistakes?
  • Is Your Training Program Failing to Stop Human Errors?
  • Are You Sure You’re Addressing the Root Causes of Errors?

Human error continues to be the primary cause of quality and production losses across regulated industries, particularly those overseen by the FDA. While eliminating human error entirely may be unrealistic, you have more control than you might think.

From the way procedures are designed to how training is delivered and how the workplace environment is structured, many factors influence human behavior and can be optimized to minimize errors.

In this series, we’ll dive into the psychology of human error, how it originates, and practical strategies for mitigating performance issues in GMP-related environments. By the end, you’ll have the tools to correct, prevent, and avoid recurring errors, significantly improving compliance and productivity.

This webinar series consists of the following 4 webinars: Total Duration : 6-hrs

• • Course 1: Optimizing Efficiency: A Comprehensive Guide to 5S Principles (Duration 90 mins)
  • Course 2: Supervising a Human Error-Free Environment: You Can Do a Lot More Than You Think (Duration 90 mins)
  • Course 3: Human Error Gen – Human Error Mitigation: Strategies for Enhanced Performance (Duration 90 mins)
  • Course 4: Building GMP Excellence: A Guide to Implementing Compliant Training Programs (Duration 90 mins)

 

PART 1: Optimizing Efficiency: A Comprehensive Guide to 5S Principles  on Oct. 29 (Tue) at 10 am PT, duration 90 mins.

Are you ready to transform your workspace into an efficient, organized, and error-resistant environment?

• • In this session, we’ll explore the 5S Methodology, a powerful system designed to help you create a workplace that is not only cleaner and safer but also more productive.
  • You’ll gain practical knowledge on how to implement the five pillars of Sort, Set in Order, Shine, Standardize, and Sustain to drive efficiency and reduce errors caused by clutter and disorganization.

By the end of this webinar, you will ….

• • Is Your GMP Compliance at Risk from Hidden Errors?
  • Are Disorganized Workflows Quietly Driving Your Error Rates Up?
  • Could Supervisory Gaps Be Repeating Costly Mistakes?
  • Is Your Training Program Failing to Stop Human Errors?
  • Are You Sure You’re Addressing the Root Causes of Errors?

Human error continues to be the primary cause of quality and production losses across regulated industries, particularly those overseen by the FDA. While eliminating human error entirely may be unrealistic, you have more control than you might think.

From the way procedures are designed to how training is delivered and how the workplace environment is structured, many factors influence human behavior and can be optimized to minimize errors.

In this series, we’ll dive into the psychology of human error, how it originates, and practical strategies for mitigating performance issues in GMP-related environments. By the end, you’ll have the tools to correct, prevent, and avoid recurring errors, significantly improving compliance and productivity.

This webinar series consists of the following 4 webinars: Total Duration : 6-hrs

• • Course 1: Optimizing Efficiency: A Comprehensive Guide to 5S Principles (Duration 90 mins)
  • Course 2: Supervising a Human Error-Free Environment: You Can Do a Lot More Than You Think (Duration 90 mins)
  • Course 3: Human Error Gen – Human Error Mitigation: Strategies for Enhanced Performance (Duration 90 mins)
  • Course 4: Building GMP Excellence: A Guide to Implementing Compliant Training Programs (Duration 90 mins)

 

PART 1: Optimizing Efficiency: A Comprehensive Guide to 5S Principles  on Oct. 29 (Tue) at 10 am PT, duration 90 mins.

Are you ready to transform your workspace into an efficient, organized, and error-resistant environment?

• • In this session, we’ll explore the 5S Methodology, a powerful system designed to help you create a workplace that is not only cleaner and safer but also more productive.
  • You’ll gain practical knowledge on how to implement the five pillars of Sort, Set in Order, Shine, Standardize, and Sustain to drive efficiency and reduce errors caused by clutter and disorganization.

By the end of this webinar, you will have actionable tools to create a well-organized and disciplined environment, setting your team up for success and minimizing human error that stems from poor workplace structure.

Key Takeaways:

• • Practical steps to implement 5S in your workspace.
  • How to eliminate inefficiencies that lead to human error.
  • Strategies to create a sustainable, error-free working environment.

PART 2: Supervising a Human Error-Free Workplace: Unleash Your Potential to Minimize Mistakes – On-demand, duration 90 mins.

As a supervisor, you hold the key to reducing human error in your team’s day-to-day operations. But how?

• • In this session, Dr. Ginette Collazo, an expert in human error reduction, will walk you through the essential strategies for creating a human error-free environment under your supervision.
  • You’ll learn how to identify and address supervision-related errors, delve into their root causes, and discover five proven elements that lead to error-free operations.

By the end of this session, you’ll have a clear framework to enhance your supervisory practices, making your team more aligned, compliant, and productive.

Key Takeaways:

• • How effective supervision can dramatically reduce human error.
  • Practical tools to identify and address root causes in real-time.
  • A roadmap for creating a culture of accountability and precision.

PART 3: Human Error Gen – Human Error Mitigation: Strategies for Enhanced Performance on Nov. 19 (Tue) at 10 am PT, duration 90 mins.

Human error doesn’t just “happen”—it starts at the design stage. From procedures and training to the overall work environment, many variables influence human behavior. The key is to control those variables effectively.

• • In this webinar, we’ll break down why human error is not the root cause but rather a symptom of deeper systemic issues.
  • We’ll explore strategies for mitigating human error, and how you can design processes, training, and environments that set your team up for success.
  • You’ll also learn how to align these strategies with the FDA’s expectations outlined in CFR Title 21.

Key Takeaways:

• • How to proactively control the variables that lead to human error.
  • Mitigation techniques that align with FDA regulations.
  • Designing systems that reduce human error from the outset.

PART 4: Building GMP Excellence: A Guide to Implementing Compliant Training Programs on Dec. 05 (Thu) at 10 am PT, duration 90 mins.

Training isn’t just a checkbox—it’s the foundation for compliance and performance. But for training programs to be effective, they need to go beyond the basics.

• • In this course, we’ll explore how to create and maintain a GMP-compliant training program that not only covers all the necessary elements but is also effective in preventing human error.
  • We’ll discuss everything from building the right curricula to managing training effectiveness and training management systems.

By the end of this session, you’ll have a robust framework for implementing compliant and effective training programs that can be ruled out as a root cause for human error, ensuring your team stays on track and compliant.

Key Takeaways:

• How to implement an error-proof GMP training program.
• Key components of effective training, including curricula and management systems.
• Ensuring training is a solution, not a root cause of human error.

This series offers a comprehensive set of strategies and practical tools to help you reduce human error, enhance compliance, and optimize productivity in your FDA-regulated environment.

With expert guidance and actionable insights, these webinars will provide the knowledge and skills needed to tackle your daily operational challenges.

Join Now!

Think your team is ready for the next FDA inspection? Surprise findings, often tied to minor human errors, have been triggering unexpected penalties and long-term disruptions.

The real danger lies in underestimating how minor lapses in training and oversight can lead to major compliance failures.

This training goes beyond surface-level solutions and dives into proven, practical strategies that you can implement immediately to reduce human error, ensure regulatory compliance, and enhance operational efficiency.

You’ll learn how to:

• • Identify root causes of errors before they spiral into bigger issues.
  • Gain access to actionable tools and methodologies that prevent mistakes from happening again.
  • Address both human behavior and system weaknesses, creating a comprehensive approach to error prevention.
  • Stay ahead of industry trends and FDA expectations, ensuring you’re always prepared for regulatory scrutiny.

By attending the full “2024 Human Error Prevention & GMP Training Courses” series, you’ll gain a comprehensive toolkit to not only address but proactively prevent human error at every level of your operations.

From supervisory strategies to workplace optimization, error mitigation techniques, and training program design, this series covers all the critical areas that impact both compliance and productivity in an FDA-regulated environment.

Attending all four webinars will position you to create a more efficient, compliant, and error-resistant organization, ensuring you’re always ahead of the curve in managing the challenges of today’s manufacturing industry.

This training isn’t just another checkbox for compliance—it’s the key to unlocking smoother, safer, and more efficient operations.

Enroll Now!

Think your team is ready for the next FDA inspection? Surprise findings, often tied to minor human errors, have been triggering unexpected penalties and long-term disruptions.

The real danger lies in underestimating how minor lapses in training and oversight can lead to major compliance failures.

This training goes beyond surface-level solutions and dives into proven, practical strategies that you can implement immediately to reduce human error, ensure regulatory compliance, and enhance operational efficiency.

You’ll learn how to:

• • Identify root causes of errors before they spiral into bigger issues.
  • Gain access to actionable tools and methodologies that prevent mistakes from happening again.
  • Address both human behavior and system weaknesses, creating a comprehensive approach to error prevention.
  • Stay ahead of industry trends and FDA expectations, ensuring you’re always prepared for regulatory scrutiny.

By attending the full “2024 Human Error Prevention & GMP Training Courses” series, you’ll gain a comprehensive toolkit to not only address but proactively prevent human error at every level of your operations.

From supervisory strategies to workplace optimization, error mitigation techniques, and training program design, this series covers all the critical areas that impact both compliance and productivity in an FDA-regulated environment.

Attending all four webinars will position you to create a more efficient, compliant, and error-resistant organization, ensuring you’re always ahead of the curve in managing the challenges of today’s manufacturing industry.

This training isn’t just another checkbox for compliance—it’s the key to unlocking smoother, safer, and more efficient operations.

Enroll Now!

PART 1: Optimizing Efficiency – A Comprehensive Guide to 5S Principles – Duration 90 mins.

1. 1. Understanding Human Error and Its Impact on Operations
   2. Types of Errors and the Psychology Behind Mistakes
   3. Introduction to the 5S Methodology
   4. Detailed Breakdown of the 5 Pillars:
      • Sort: Eliminate Unnecessary Items
      • Set in Order: Organize Tools and Materials
      • Shine: Cleanliness as a Part of Daily Work
      • Standardize: Establish Clear Standards
      • Sustain: Maintain the Gains and Discipline
   5. Benefits of 5S for Operators: Enhancing Daily Workflows
   6. Organizational Benefits of 5S: Efficiency, Safety, and Compliance
   7. Strategies to Support 5S Implementation
   8. Overcoming Common Challenges in 5S Adoption
   9. Final Conclusions and Next Steps

PART 2: Supervising a Human Error-Free Environment – Duration 90 mins.

1. 1. Introduction to Human Error: Definition and Overview
   2. Importance of Preventing and Reducing Human Error in GMP Settings
   3. Role of Supervision in Human Error Prevention
   4. Common Supervisory Errors and How to Avoid Them
   5. Understanding When Operator Error Is Truly the Root Cause
   6. How Supervision Controls and Reduces Human Error
   7. Common Mistakes: Memory Failures, Overconfidence, and Detection Gaps
   8. Tracking and Trending Human Error Rates and Supervision’s Role
   9. Implementing CAPA for Human Error: Effectiveness and Best Practices

PART 3: Human Error Mitigation – Strategies for Enhanced Performance – Duration 90 mins.

1. 1. Understanding the Psychology of Error and Human Behavior
   2. Regulatory Requirements for Managing Human Performance Deviations in GMP
   3. Root Cause Analysis and Investigation Techniques
   4. Tools for Root Cause Determination: Practical Applications
   5. Establishing Human Error Rates at Your Facility
   6. Implementing a Human Error Mitigation Program
   7. Metrics and Key Performance Indicators (KPIs) for Success
   8. Tracking Progress and Continuous Improvement
   9. Addressing Challenges in Human Error Mitigation Programs

PART 4: Building GMP Excellence – A Guide to Implementing Compliant Training Programs – Duration 90 mins.

1. 1. GMP Regulations Regarding Training Programs
   2. Regulatory Agencies’ Expectations for Effective Training
   3. General Aspects of Training in a GMP Environment
   4. Responsibilities of the Training Program Management
   5. Training Requirements for New Employees and Transferred Staff
   6. Managing Training for External Service Providers
   7. Designing and Conducting Training Events
   8. On-the-Job Training (OJT) and Skills Qualification Programs
   9. Assessing Training Effectiveness and Implementing Retraining
   10. Developing a Comprehensive Training Outline and Curriculum
   11. Technical Training, GMP-Specific Training, and Training Frequency
   12. Instructor Qualifications and Training Documentation Requirements
   13. Reviewing the Effectiveness of the Training System
   14. Addressing Deviations Related to Performance and Training Outcomes

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.
   3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.

PART 1: Optimizing Efficiency – A Comprehensive Guide to 5S Principles – Duration 90 mins.

1. 1. Understanding Human Error and Its Impact on Operations
   2. Types of Errors and the Psychology Behind Mistakes
   3. Introduction to the 5S Methodology
   4. Detailed Breakdown of the 5 Pillars:
      • Sort: Eliminate Unnecessary Items
      • Set in Order: Organize Tools and Materials
      • Shine: Cleanliness as a Part of Daily Work
      • Standardize: Establish Clear Standards
      • Sustain: Maintain the Gains and Discipline
   5. Benefits of 5S for Operators: Enhancing Daily Workflows
   6. Organizational Benefits of 5S: Efficiency, Safety, and Compliance
   7. Strategies to Support 5S Implementation
   8. Overcoming Common Challenges in 5S Adoption
   9. Final Conclusions and Next Steps

PART 2: Supervising a Human Error-Free Environment – Duration 90 mins.

1. 1. Introduction to Human Error: Definition and Overview
   2. Importance of Preventing and Reducing Human Error in GMP Settings
   3. Role of Supervision in Human Error Prevention
   4. Common Supervisory Errors and How to Avoid Them
   5. Understanding When Operator Error Is Truly the Root Cause
   6. How Supervision Controls and Reduces Human Error
   7. Common Mistakes: Memory Failures, Overconfidence, and Detection Gaps
   8. Tracking and Trending Human Error Rates and Supervision’s Role
   9. Implementing CAPA for Human Error: Effectiveness and Best Practices

PART 3: Human Error Mitigation – Strategies for Enhanced Performance – Duration 90 mins.

1. 1. Understanding the Psychology of Error and Human Behavior
   2. Regulatory Requirements for Managing Human Performance Deviations in GMP
   3. Root Cause Analysis and Investigation Techniques
   4. Tools for Root Cause Determination: Practical Applications
   5. Establishing Human Error Rates at Your Facility
   6. Implementing a Human Error Mitigation Program
   7. Metrics and Key Performance Indicators (KPIs) for Success
   8. Tracking Progress and Continuous Improvement
   9. Addressing Challenges in Human Error Mitigation Programs

PART 4: Building GMP Excellence – A Guide to Implementing Compliant Training Programs – Duration 90 mins.

1. 1. GMP Regulations Regarding Training Programs
   2. Regulatory Agencies’ Expectations for Effective Training
   3. General Aspects of Training in a GMP Environment
   4. Responsibilities of the Training Program Management
   5. Training Requirements for New Employees and Transferred Staff
   6. Managing Training for External Service Providers
   7. Designing and Conducting Training Events
   8. On-the-Job Training (OJT) and Skills Qualification Programs
   9. Assessing Training Effectiveness and Implementing Retraining
   10. Developing a Comprehensive Training Outline and Curriculum
   11. Technical Training, GMP-Specific Training, and Training Frequency
   12. Instructor Qualifications and Training Documentation Requirements
   13. Reviewing the Effectiveness of the Training System
   14. Addressing Deviations Related to Performance and Training Outcomes

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.
   3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.

Everybody Benefits from Watching This. Even Better When Done as a Group!

This series is designed for professionals in GMP-regulated manufacturing facilities including pharmaceuticals, medical devices, biologics, food, nutrition, and any other organization where employees are involved in activities that could lead to human error.

Key roles that will benefit include:

• • Training Managers and Coordinators
  • Operations and Manufacturing Personnel
  • Plant Engineering Teams
  • QA/QC Staff
  • Process Excellence/Improvement Professionals
  • Industrial and Process Engineers
  • Compliance Officers
  • Regulatory/Legislative Affairs Professionals
  • General and Corporate Counsel

Everybody Benefits from Watching This. Even Better When Done as a Group!

This series is designed for professionals in GMP-regulated manufacturing facilities including pharmaceuticals, medical devices, biologics, food, nutrition, and any other organization where employees are involved in activities that could lead to human error.

Key roles that will benefit include:

• • Training Managers and Coordinators
  • Operations and Manufacturing Personnel
  • Plant Engineering Teams
  • QA/QC Staff
  • Process Excellence/Improvement Professionals
  • Industrial and Process Engineers
  • Compliance Officers
  • Regulatory/Legislative Affairs Professionals
  • General and Corporate Counsel