Manufacturing
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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..
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..
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..
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..
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..
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..