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 …
Upcoming Webinars
Managing Toxic & Other Employees Who Have Attitude Issues
Effective Onboarding: How to Welcome, Engage, and Retain Ne…
Analytical Method Validation Under Good Laboratory Practic…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Sunshine Act Reporting - Clarification for Clinical Research
Onboarding New Hires: Leverage the Potential of Artificial …
Do's and Don'ts of Giving Effective Feedback for Performanc…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Using Behavior Based Interviewing for Finding the Best Matc…
How to Document Employee Discussions and Why it is Important
Project Management for HR, Administrative Professionals, an…
Stressed Out: How to Handle Conflict, Difficult People and …
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Marketing to Medicare or Medicaid Beneficiaries - What You …
Understanding the Artificial Intelligence Landscape
Best Practices for Working With Vendors and Suppliers
Accounting For Non Accountants : Debit, Credits And Financi…
Principles & Practices for the Cybersecurity of Legacy Medi…
Independent Contractor vs. Employee New Rule Issued by The …
The Top Ten Excel Functions Everyone Should Know
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Clinical Trial Systems: The Trial Master File (TMF) and Ele…
Dealing With Difficult People In Life & Work
Improving Employee Engagement & Retention Through Stay Inte…
Fair Lending in Q2 2024: new regulations, examinations, and…
FDA Regulation of Artificial Intelligence/ Machine Learning
Form 1099 Update 2024: Latest Forms, Rules and Reporting Re…
Coming Soon - New Minimum Salary Levels for Exempt Employee…
Beyond ‘Illegal’ Interview Questions: What Recruiters & Hir…
Bootcamp for New Managers and Supervisors: Avoid These 7 Mi…
Writing Techniques for Auditors and Risk Management Profess…
Coaching & Retaining Your Talent – Putting the WOW into Qua…
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Emotional Intelligence: Mastering the Emotions of Great Lea…
Building Fair Chance Hiring Policies in 2024
Effectively Handle Toxic People for Better Productivity and…
Third-Party Relationships: Risk Management: What All Bankin…
HR 101 - Bootcamp Basics for New Human Resource Professiona…
How to Manage and Resolve Conflict in the Workplace
Impact Assessments For Supplier Change Notices
Performance Management with Bottom-Line Results
How to Give Corrective Feedback: The CARE Model - Eliminati…
Human Error Reduction Techniques for Floor Supervisors
Credit Risk Discipline Tools - Implementing 14 Tools for Cr…
FDA Compliance And Laboratory Computer System Validation