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
HIPAA Compliance in 2026 — Practical Strategies for Breach …
Launch Your Career: The Ultimate Guide for Emerging Profess…
Moving From an Operational Manager to a Strategic Leader
Discover how Emotional Intelligence turns AI from a technic…
Dealing With Difficult People: At Work & In Life
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Empowering Conflict Resolution: Letting Go to Gain Control
The 60 Minutes Introduction to DAX
The 6 Most Common Problems in FDA Software Validation and V…
High-Impact Performance Management: Tools, Tactics & Coachi…
AI Across the Business: Practical Use Cases for Founders an…
Faster, Better Talent Acquisition: Leveraging AI & ChatGPT …
The Anti-Kickback Statute: Enforcement and Recent Updates
Do's and Don'ts of Giving Effective Feedback for Performanc…
Emotional Intelligence: Mastering the Emotions of Great Lea…
Copilot and HR: An Introduction for HR Professionals
Goal Mastery: From Resolutions to Results in 2026
Your AI Advantage: How HR Professionals Can Use Claude to S…
Human Error Reduction Techniques for Floor Supervisors
Validation of FDA-Regulated Medical Device and SaMD Product…
Human Factors Usability Studies Following ISO 62366 and FDA…
Managing Toxic & Other Employees Who Have Attitude Issues
I-9 Enforcement & Compliance: A 5-Step Plan for Employers t…
Major cGMP Issues: FDA Concerns in 2026
4-Hour Virtual Seminar on Transformational Leadership - The…
Understanding EBITDA – Definition, Formula & Calculation
DOL Reverses Course on Independent Contractor Rule for 2026…
Managing Toxic Employees: Strategies For Leaders To Effecti…
ChatGPT and Project Management: Leveraging AI for Project M…
Navigating HR Like A Pro: What Every Small Business & New H…
HPLC Analytical Method Development and Validation
Negotiating Skills For Professional Results - Winning Strat…
Managing Projects When AI Joins the Team: Human Judgment, A…
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Paying and Receiving Payments for Referrals: You Can Go to …
Ten Red Flags that Signal Financial Distress in Business Cu…
The Age-Inclusive Workplace: How to Lead and Work Across Ge…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Fatal Errors Employers Make When Updating Employee Handbook…
AI Fundamentals for All Leaders and Managers: How to Work S…