Manufacturing
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Grok the Muda
Robert A. Heinlein's Stranger in a Strange Land defines "Grok" as "To understand so thoroughly that the observer becomes a part of the observed" A parts changer follows the instruction manual; a mechanic groks the machine. Taiichi Ohno wrote, "To implement the Toyota production system in your own business, there must be a total understanding of waste". The purpose of this webinar is to teach attendees to id..
Lose the Luddites
Luddism is the (usually) dysfunctional belief that automation eliminates jobs and results in unemployment. The truth is that automation and productivity improvements protect jobs by reducing the cost of the product or service to keep it competitive. Henry Ford, for example, made automobiles affordable to the middle class which actually created far more automotive jobs and jobs in supporting industries. It i..
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..
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 Rebuild American Manufacturing
Ms.Nash-Hoff’s presentation will cover how new trends and technologies are contributing to rebuilding American manufacturing and what government policies and legislation have benefited rebuilding American Manufacturing. She will discuss how the trend of returning manufacturing to America (reshoring) is increasing manufacturing output in the U.S. and how the increased desire of consumers to buy Made in..
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..
Variation: Enemy of Productivity
Luck (variation) is no lady and Kismet (fortune) is no gentleman, at least not in product and service realization activities. Variation is a form of what General Carl von Clausewitz called friction: "the force that makes the apparently easy so difficult," and "countless minor incidents, combine to lower the general level of performance so that one always falls short of the intended goal." Variation can wrea..
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..
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 ..