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Corrective and preventive action (CAPA) is required by ISO 9001:2015 and is also common sense; we don't want to have to solve the same problem more than once. The automotive IATF 16949:2016 standard adds...
Data integrity refers to the accuracy, completeness, and consistency of data over its entire lifecycle. Data integrity is crucial for any organization as it ensures that the data they rely on to make deci...
Everyone in a laboratory under compliance knows about 3-sigma out-of-control issues. Can the operation be monitored to avoid these? How? This webinar will cover the basic statistics of compliance and non-...
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 Manu...
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 c...
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 qu...
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...
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...
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 Federa...