Live Webinar How to Write Error Free and FDA Compliant Procedures
01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes
Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar
"Hear By Dr. Ginette Collazo — a 15 year veteran of helping drug, biologic and device firms reduce manufacturing errors"
This course offers practical approaches and tools to address human performance issues in GMP related environments
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. When working with these challenges, it is imperative to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are so that they can be improved and fixed. This course offers practical approaches and tools to address human performance issues in GMP related environments by using a particular methodology to correct, prevent and avoid reoccurrence of these matters.
• Background on Human Error Phenomena and Measurement.
• The importance of Human Error Prevention/reduction.
• Quantitative and qualitative information gathering.
• Why do we need tools for human error reduction programs?
• Training as a tool and human error.
• Facts about human error and training.
• Human Error as the Root Cause: what to do and how to measure it.
o Root Cause Analysis
o Cognitive load assessment
o Systems available
o Human error rate
o Floor checklist
o Interview questions
• Human error rates and other metrics
• Trending and Tracking
• Metrics and Human Error
o Human Error rate
o 1st-time pass rate
o Overall equipment effectiveness (OEE)
o Trending /Tracking
Key Learning Objectives of your Topic:
• Understand human error: factors and causes.
• Understand the importance: regulatory and business.
• Define the process to manage Human Error deviations.
• Learn about human error measurement.
• Learn about tools for measurement.
• Establish Key Performance Indicators.
• Define and measure human error rate, cognitive load, and CAPA effectiveness
• Identify what I can do to support human reliability.
Who will Benefit
• Training managers and coordinators
• Plant Engineering
• QA/QC staff
• Process excellence/improvement professionals
• Industrial/process engineers
• Compliance officers
• Regulatory/legislative affairs professionals
• General/corporate counsel
• Executive management
Industries who can attend
This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.