This presentation by Ginette Collazo will discuss key topics including content development and formats designed for human error reduction due to procedures. Procedures are important for both execution and audits. These should be written for users without missing important information for regulators. Usually, procedures have weaknesses that harm productivity, quality, and regulatory standing.
WHY SHOULD YOU ATTEND?
One of the major causes for incurring quality and production losses in many industries is human error. Although it is unlikely that human error can ever be totally abolished, many human performance problems could be prevented. Human errors begin at the design stage. Procedures play a vital role in human reliability. Nevertheless, it is extremely necessary to understand human behavior and the psychology of error as well as understand exactly where the instruction's weaknesses are, so procedures can be human-engineered, improved, and/or fixed.
AREA COVERED
- SOP writing outline
- Content development
- The rationale for procedure use
- Regulatory compliance background
- Universal purpose of procedures
- The human perspective
- Human error as a root cause
- The thinking and reading process
- Common mistakes and causes
- How to create and maintain a procedure
- Goals of a procedure
- Good procedure writing practices (Terminology, formats, layouts, mixed cases, steps content, common words, references, branching, conditional steps, the use of precautions, warnings, and Cautions)
- Procedure styles
- Use of electronic information networks for procedure access
LEARNING OBJECTIVES
- Understand the importance of procedures
- Learn why people refuse to use procedures
- Learn the best formats and content elements for SOPs
- Learn document hierarchy and different types of procedures based on their use
- Understand the common Human Errors and deviations related to the use of procedures
- Understand the reading and writing processes and how people may impact the processes
WHO WILL BENEFIT?
- QA/QC directors and managers
- Process improvement/excellence professionals
- Training directors and managers
- Plant engineering
- Compliance officers
- Regulatory professionals
- Executive management
- Manufacturing operations directors
- Human factors professionals
One of the major causes for incurring quality and production losses in many industries is human error. Although it is unlikely that human error can ever be totally abolished, many human performance problems could be prevented. Human errors begin at the design stage. Procedures play a vital role in human reliability. Nevertheless, it is extremely necessary to understand human behavior and the psychology of error as well as understand exactly where the instruction's weaknesses are, so procedures can be human-engineered, improved, and/or fixed.
- SOP writing outline
- Content development
- The rationale for procedure use
- Regulatory compliance background
- Universal purpose of procedures
- The human perspective
- Human error as a root cause
- The thinking and reading process
- Common mistakes and causes
- How to create and maintain a procedure
- Goals of a procedure
- Good procedure writing practices (Terminology, formats, layouts, mixed cases, steps content, common words, references, branching, conditional steps, the use of precautions, warnings, and Cautions)
- Procedure styles
- Use of electronic information networks for procedure access
- Understand the importance of procedures
- Learn why people refuse to use procedures
- Learn the best formats and content elements for SOPs
- Learn document hierarchy and different types of procedures based on their use
- Understand the common Human Errors and deviations related to the use of procedures
- Understand the reading and writing processes and how people may impact the processes
- QA/QC directors and managers
- Process improvement/excellence professionals
- Training directors and managers
- Plant engineering
- Compliance officers
- Regulatory professionals
- Executive management
- Manufacturing operations directors
- Human factors professionals
Speaker Profile

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 …
Upcoming Webinars

Female to Female Hostility @Workplace: All you Need to Know

Maximizing Productivity with ChatGPT: AI Solutions for HR, …



2-Hour Virtual Seminar on Empowering Presentations with Pow…

Pivot tables beginner to advanced + 20 advanced Pivot table…

Understanding Artificial Intelligence (AI) & using Chat GPT

Creating Loyal Customers Through Excellent Customer Service

Understanding and Communication New Immigration Policies (2…

Navigating Talent Management and Retention Strategies.

HIPAA is Unsettled – Safe Compliance Strategies

Project Management for Non-Project Managers - Scheduling yo…

How to Prepare For and Host a FDA Inspection and Respond to…

Empowering Conflict Resolution: Letting Go to Gain Control

Onboarding Best Practices for 2025: Proven Strategies to Po…

Navigating 2025 Employment Laws: What Every Employer Needs …


Managing Toxic Employees: Strategies For Leaders To Effecti…

How to Conduct Exit Interviews - Implementing and Enhancing…

Adapting to Change: Strategies for Personal & Team Resilien…

Introduction to Excels Built-In Solver – Advanced Decision-…

How to Manage the Legal Landmine of the FMLA, ADA and Worke…

FDA Technology Modernization Action Plan (TMAP) and Impact …

Design Control for Medical Devices Including Verification/V…

Stress, Change And Team Resilience Through Humor: An Intera…


Developing and Implementing Quality Culture in the Organiza…

GROUPBY and PIVOTBY functions. Pivot table killers?


Negotiating Skills For Professional Results - Winning Strat…

Use the power of AI to turbocharge your MS Excel


Trust in Leadership: Building and Maintaining Trust as a Le…

Conquer Toxic People - Learn To Protect Yourself And Get Yo…

Excel - Pivot Tables - The Key To Modern Data Analysis and …

AI and Human Resources: The Great Opportunity!

Tools and Tactics for Grieving, Surviving, and Thriving in …

Bootcamp for New Managers and Supervisors: Develop These Es…

How To Conduct An Internal Harassment And Bullying Investig…

How Generative AI can be used in Banking Risk and Compliance

Creating Employee Handbooks that Protect You and Support th…

Excel Power Skills: Master Functions, Formulas, and Macros …

Emotional Intelligence: Mastering the Emotions of Great Lea…

Managing Toxic & Other Employees Who Have Attitude Issues


The Five Cs Of Commercial Credit: The Basic Elements Of Cre…

SOPs - How to Write Them to Satisfy those Inspectors

Improving Employee Engagement & Retention Through Stay Inte…


How to Give Corrective Feedback: The CARE Model - Eliminati…