Training Doyens

Human error is known to be the primary cause of quality and production losses in many industries and it’s important to understand exactly where the instruction weaknesses are so that procedures can be human engineered, improved and fixed. Our upcoming webinar discusses how to create and maintain a procedure, starting from content development to formats designed for human error reduction due to procedures. The webinar covers the following key areas: ·          SOP writing rules and regulatory compliance background ·          The thinking and reading process, and common mistakes and causes ·          Use of electronic information networks for procedure access LEARNING OBJECTIVES We will discuss how to create and maintain a procedure, starting from content development to formats designed for human error reduction due to procedures. WHO WILL BENEFIT ...

OVERVIEW 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. Procedures play a vital role in human reliability. Nevertheless, it is essential to understand why people don't follow procedures, based on human behavior and the psychology of error. It’s also important to understand exactly where the instructions weaknesses are so that procedures can be human engineered, improved and fixed. WHY SHOULD YOU ATTEND Procedures are essential for both execution and audits. These should be written for users without missing relevant information for regulators. Usually, procedures have weaknesses that harm productivity, quality, and regulatory standing. By attending the webinar you’ll understand why people don't follow procedures and techniques for human error reduction and prev...

To reduce human errors it is imperative to understand human behavior, human error metrics 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. Our upcoming boot camp discusses practical approaches and tools for human error reduction and prevention in GMP related environments and methodologies for human error assessments, correction, prevention and avoidance of reoccurrence of these matters. The boot camp covers the following key areas: ·          Understand human error: factors and causes ·          Define and measure human error rate, cognitive load, and CAPA effectiveness ·          Define the process to manage human error deviations ·          Establish Key Performance Indicators ·        ...

A ddressing human error deviations in the GMP regulated industry is important not only because they are an inconvenience but also because the regulation requires it. Our upcoming webinar discusses how to implement a human error reduction program at your site and how to measure its effectiveness. The webinar covers the following key areas: ·          6 step method for human error prevention ·          Human error rates and measurement ·          Trending, tracking, prediction, and effectiveness LEARNING OBJECTIVES • Human error reduction System • 6-step implementation process • HES tools • Human error program implementation • Metrics and KPI’s WHO WILL BENEFIT • Training managers and coordinators • Operations • Manufacturing • Plant engineering • QA/QC staff • Process excellence/improvement professionals • Industrial/process eng...

OVERVIEW 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, that they have been fully investigated…” Also, the European Commission reads “Where 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 o...

OVERVIEW 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. To work with these challenges, it is essential 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/or fixed. This course offers practical approaches and models to address human performance issues in  GMP  related environments by using a particular methodology to correct, prevent and avoid reoccurrence of these matters. WHY SHOULD YOU ATTEND This human error prevention training would provide tools that can be implemented and used after this eve...

OVERVIEW This course offers practical approaches and tools for human error reduction and prevention in GMP related environments by using a particular methodology for human error assessments, correction, prevention and avoidance of reoccurrence of these matters. WHY SHOULD YOU ATTEND 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, human error metrics 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. AREAS COVERED Background on h...