Quality and Safety
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..
Continues Improvements using 7 Basic Quality Tools
The Seven Basic Quality Tools, also known as “The original seven” or “The basics for Quality job” or “Must-know Quality Tools” as well as the most frequently used Quality tools, were first promoted by Kaoru Ishikawa, a professor of engineering at Tokyo University and the father of "quality circles." These tools, while there can be slight variations, include a Cause-and-effect diagram (also called Ishikawa o..
Current Good Manufacturing Practices
Current Good Manufacturing Practices, which include current good documentation practices, and elements of continuous improvement are both a law (regulations) and the right thing to do for any manufacturing operations.During this webinar, we will focus on 15, basic-to-intermediate, practices, including what they mean, how they work together, and why they stimulate continuous improvement (and yes, they do not..
False Claims Act (or Whistleblower Act) and Hospital Fraud
A whistleblower or qui tam action can provide financial rewards to individuals who provide information that a company, hospital, or individual has defrauded the government. The primary statutes under which this relief may be sought are the federal and state False Claims Acts (“FCAs”). State and federal governments pay hundreds of billions of dollars each year for pharmaceutical drugs, medical devices, hospi..
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..
Good and Bad Practices in Risk Analysis
Selecting the most appropriate risk treatment option involves balancing the costs and efforts of implementation against the benefits derived, with regard to legal, regulatory, and other requirements such as social responsibility and the protection of the natural environment. A number of treatment options can be considered and applied either individually or in combination. Risk treatment itself can introduce..
How to Prepare for and Conduct a Regulatory Audit
This session will be highly interactive with audience members actively participating in an open discussion of their audit experience. Through discussion and examples, participants will gain an understanding of how to prepare for an audit, strategies to conduct and support a successful audit, and ways to respond to audit observations. Special consideration will be given to virtual audits as a result of the C..
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 ..
ISO 14001 Environmental Management Systems
ISO 14001 is an internationally agreed standard that sets the requirements for environmental management systems. It helps organizations improve their environmental performance through more efficient use of resources and reduction of waste, gaining a competitive advantage and the trust of stakeholders. ISO 14001 is suitable for any organization -- all types and sizes, be they private, not-for-profit or gover..
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 ..