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BEST-SELLER : How to implement an effective Human Error Reduction Program
If you work in the GMP-regulated industry, you not only need to address human error deviations because they are an inconvenience, but you must also 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 the quality control unit.” and it states that “(a) There shall be a qualit..
Contract Manufacturing: Responsibility and Accountability
This course dives deep into the critical aspects of overseeing contract manufacturing to guarantee quality, compliance, and accountability. Participants will explore strategies for effective oversight, risk mitigation, and best practices to ensure reliable and high-quality production outputs from third-party manufacturers. The curriculum covers essential legal and regulatory frameworks for managing contract..
Human Error Reduction Techniques for Floor Supervisors
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, and communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allow it. To work with these challenges, it is essential to understand human behavior and the psychology of error as well as understand exactly where ..
5S or 7S Lean Manufacturing and Workplace Organization – What Happened to 6S?
5S began as part of the Toyota Production System (TPS), the manufacturing method begun by leaders at the Toyota Motor Company in the early and mid-20th century. This system, often referred to as Lean Manufacturing in the West, aims to increase the value of products or services for customers. This is often accomplished by finding and eliminating waste from production processes. The term 5S comes from five Ja..
How to Address ISO's New Climate Change Requirements?
ISO 9001:2015's successor, and other ISO standards, will soon include clauses related to climate change. The good news is that, if your organization already has a process to address risks to continuity of operations, including risks associated with climate-driven weather events, it is probably doing most if not all of what it needs to do to meet the new requirements. It is however important to not divert su..
Human error reduction in GMP manufacturing/floor
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. 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 h..
Production Control Principles and Practices
This program is a introduction to the tools needed to perform Production Control principles/practices. It will explain the resources needed to accomplish the schedules and budgetary limits established for satisfying customer needs.Understanding the different operating environments (Engineer to Order, Make to Order, Make to Stock, and others) will provide the responsible leadership and operating personnel wi..
Seeing the Waste: Henry Ford's Lean Success Secret
Enormous waste (muda) can hide in plain sight for years or even longer because everybody in the workplace takes it for granted, and is used to living with it or working around it. This waste can however consist of up to 95 percent of the labor, and a large portion of materials and energy as well. Henry Ford, whose success speaks for itself, identified three key performance indicators (KPIs) for waste that e..
Ten Keys for Maximizing the Benefits of your SPC Program
Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to “listen” to their processes so that potentially harmful changes will be quickly detected and rectified. However, not all SPC programs deliver to their highest capability as there are many elements to get right to achieve maximum utility. Highly effective SPC programs combin..
Audit Trail Generation and Review
Computerized systems are used throughout the life sciences industry to support various regulated activities, which in turn generate many types of electronic records. These electronic records must be maintained according to regulatory requirements contained within FDA’s 21 CFR Part 11 for US jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions.One of the requirements for such compliance is the g..
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
Analysis of investigation reports reveals that human error is one of the top root causes for deviations, discrepancies and quality incidents in pharmaceutical manufacturing. And when you examine the CAPA's that are developed from these, retraining and rewrite of SOP is top the list. Yet on further re-examination, you find that these problems keep resurfacing again and again. Put in another way, the CAPA's a..
Device and Software Changes and The 510(k)
This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results-driven 510(k) / change analysis activities, based on the U.S. FDA has its current two recent “Final Guidance for Industry and FDA Staff”: “Deciding When to Submit a 510(k) for a Change to an Existing Device”; and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device..
Generation of Controlled Documents and Related Training
This presentation is intended to provide the needed documentation practices associated with documentation creation, document approval, handwritten entries, copies of documents, document maintenance and document modification. This document details the minimum documentation requirements for MEDIn still personnel, contractors and consultants completing cGMP documents. Specific operational procedures using more..
Human Error Reduction Techniques For Floor Supervisors
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allow it. To work with these challenges, it is essential to understand human behavior and the psychology of error as well as understand exactly where the ..
Product Development and Manufacturing
Conceptualizing, designing, creating, and developing, manufacturing and growing products from start to finish is a time-consuming, arduous endeavor. To increase your chance of success, we will review in depth the following nine steps to take your idea from conception to launch.1. Discover/ Validate an Innovative Product (with a Purpose)New product innovation begins with a problem or inspiration. What needs ..