If you work in the GMP-regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it. For example the CFR - Code of Federal Regulations Title 21 Subpart B_Organization and Personnel Sec. 211.22 talks about the “responsibilities of quality control unit” and it states that “(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred, or if errors have occurred, they have been fully investigated…”
Also, the European Commission reads, “Where a human error is suspected or identified as the cause; this should be justified having taken care to ensure that process, procedural or system-based errors or problems have not been overlooked if present. Appropriate corrective actions and/or preventative actions (CAPAs) should be identified and taken in response to investigations. The effectiveness of such actions should be monitored and assessed, in line with Quality Risk Management principles.” We, at Human Error Solutions (HES), have created the simplest and most effective human error reduction program, with 100% effectiveness when fully implemented in different organizations around the world. This valid scientific model combines qualitative and quantitative methodologies and provides practical tools that would assist your organization in achieving desired results.
WHY SHOULD YOU ATTEND?
This training will provide the steps that you will be able to implement in a human error reduction program at your site. It includes practical tools, the six steps for implementation, and how to measure effectiveness to continuously improve human reliability at your site.
AREA COVERED
- What is human error?
- How is human error controlled?
- The 6-step method for human error prevention
- Human error rates and measurement
- Trending and tracking
- Prediction
- Effectiveness
LEARNING OBJECTIVES
- Human error reduction System
- 6-step implementation process
- HES tools
- Human error program implementation
- Metrics and KPIs
WHO WILL BENEFIT?
- Training managers and coordinators
- Operations
- Manufacturing
- Plant engineering
- QA/QC staff
- Process excellence/improvement professionals
- Industrial/process engineers
- Compliance officers
- Regulatory/legislative affairs professionals
- General/corporate counsel
This training will provide the steps that you will be able to implement in a human error reduction program at your site. It includes practical tools, the six steps for implementation, and how to measure effectiveness to continuously improve human reliability at your site.
- What is human error?
- How is human error controlled?
- The 6-step method for human error prevention
- Human error rates and measurement
- Trending and tracking
- Prediction
- Effectiveness
- Human error reduction System
- 6-step implementation process
- HES tools
- Human error program implementation
- Metrics and KPIs
- Training managers and coordinators
- Operations
- Manufacturing
- Plant engineering
- QA/QC staff
- Process excellence/improvement professionals
- Industrial/process engineers
- Compliance officers
- Regulatory/legislative affairs professionals
- General/corporate counsel
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
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
Understanding the incredible uses and fallbacks of ChatGPT
Project Management for administrative professionals
Accounting For Non Accountants : Debit, Credits And Financi…
Coaching At Work- Improving Employee Engagement And Perform…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Onboarding is Not Orientation: How to Improve Your New Hire…
Using High-Performance Coaching for Managers to Address Per…
21 CFR Part 11 - Compliance for Electronic Records and Sign…
California Meal and Rest Breaks: What You Dont Know Can Cos…
Writing Techniques for Auditors and Risk Management Profess…
Responding to EEOC Discrimination Charges-What's Your Busin…
When Employees Travel: Wage and Expense Rules Employers Mus…
Conflict Resolution - Prevent, De-escalate, Resolve
Female to Female Hostility @Workplace: All you Need to Know
Implementing an Effective Human Error Reduction Program
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Form 1099-MISC and 1099-NEC Compliance Update 2024
Validation Statistics for Non-Statisticians
The Totally Organized Professional Is All About Outcomes
Project Management for Non-Project Managers - Scheduling yo…
Why EBITDA Doesn't Spell Cash Flow and What Does
GAMP5, Second Edition and Alignment with Computer Software …
Sunshine Act Reporting - Clarification for Clinical Research
Understanding the Math of HR… So You Can Show How HR Impact…
I-9 Audits: Strengthening Your Immigration Compliance Strat…
FFIEC BSA/AML Examination Manual: What Compliance Officers …
How to Address ISO's New Climate Change Requirements
Re-imagine Finance & Accounting Made Simple. Three Webinars…
Stay Interviews: A Powerful and Low-Cost Employee Engagemen…
How To Conduct An Internal Harassment And Bullying Investig…
Effective Onboarding: How to Welcome, Engage, and Retain Ne…
Managing Toxic & Other Employees Who Have Attitude Issues
Analytical Method Validation Under Good Laboratory Practic…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Onboarding New Hires: Leverage the Potential of Artificial …
Do's and Don'ts of Giving Effective Feedback for Performanc…
Understanding the Artificial Intelligence Landscape
Marketing to Medicare or Medicaid Beneficiaries - What You …
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Principles & Practices for the Cybersecurity of Legacy Medi…
Independent Contractor vs. Employee New Rule Issued by The …