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 M. Collazo
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
How to Write Procedures to Avoid Human Errors
Recruiting Top Talent in a Digital Era
Copilot and HR: An Introduction for HR Professionals
The Importance of the first 5 seconds when presenting
Microsoft Excel - Data Validation Techniques
Using Claude in Excel for Productivity, Automation & Data A…
AI for Excel Professionals: Enhancing Productivity with Cha…
Leadership: Strategic Planning and Decision Making
2026 Form I-9 Changes & New ICE Penalties: What Every Emplo…
Human Factors Usability Studies Following ISO 62366 and FDA…
FDA Compliance for Regulated Systems using COTS, Cloud, and…
Implementing an Effective Succession Plan to Identify, Deve…
Boost Financial Analysis with Claude in Excel
ChatGPT for HR - Build HR Policy Framework and Strategy
Wage & Hour Laws: Ensuring Compliance with the Fair Labor S…
Emotional Intelligence: Mastering the Emotions of Great Lea…
I-9 Enforcement & Compliance: A 5-Step Plan for Employers t…
The Anti-Kickback Statute: Enforcement and Recent Updates
Expense Reimbursements 2026 - Proper Recordkeeping and Acco…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Dealing With Difficult People: At Work & In Life
Construction Lending And Real Credit Administration: Evalua…
Claude AI For CPAs & Finance Professionals: Best Practices …
Mastering the Prompt: How Every Professional Can Use AI to …
Secrets Of The Staffing Fix - Solving The Employee Training…
Using Copilot to Format Legal Documents in Microsoft Word
Setting SMART Goals & Leveraging Storytelling for Reporting
Eliminate Harmful And Unproductive Drama In The Workplace
Discover how Emotional Intelligence turns AI from a technic…
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Major cGMP Issues: FDA Concerns in 2026
Elevate Your Workplace Wellness: 10 Critical Wellness Facto…
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
Managers/Supervisors: New Role, Same Team - How to Lead Wit…