Quality Management
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..
Validation Sampling Plans, Setting Acceptance Specifications and Statistical Process Control
This workshop will explore the topic of setting appropriate sampling plans and using those plans to set appropriate acceptance criteria for process validations. Using a 5 step method, the attendee will come away with a good understanding of sampling for validation including using risk to make sampling decisions. It will also explore using variance to set acceptance criteria for test method validation. Lastl..
Adaptive S & OP
Companies are facing an ever more increasingly complex environment coupled with increasing marketplace volatility. This is causing companies to strive to be more flexible and responsive by streamlining both planning and execution. In addition, companies are attempting to conserve the use of their valuable resources. Instead of investing in products prematurely that then creates an inventory that may not be ..
Artificial Intelligence and the Law
In this practical webinar, you will learn about the latest developments in Artificial Intelligence and get a glimpse into the future, as additional legal tasks get automated.Upon course completion, you will be able to:Define “machine learning”Describe how machine learning is already being used by law firmsEvaluate how Artificial Intelligence is changing legal jobsConsider the ethical implications of Artific..
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..
Audit2020: Evolving the Internal Audit Process
The internal audit profession is very similar to other professions; very resistant to change. When one of our profession’s main goals is to promote efficiency and effectiveness, we have to be more adept at adjusting and being open-minded to change. Audit2020 is a course that takes an in-depth look at the accepted practices inherent in internal audit and critically analyses each piece, identifying ways to en..
Best Practices for Using Your Quality Management System’s Quality Objectives and KPIs for Meaningful Process Improvement
Numbers, data, facts, perfect information all allow us to make more informed less risky decisions in every aspect of our lives. Due to the increased demands and business pressures to do more with fewer resources, decision-makers in every organization are tasked with making fast and informed decisions.Knowing how what to measure, how to measure it, what the data says where you are now, where you want to be i..
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..
From Training to Human Reliability In Manufacturing
Pharmaceutical manufacturing sites continuously compete, even within the same company to maintain production volumes and avoid closures. To attain a status of a high performing organization manufacturing sites are implementing strategies and practices like operational excellence and performance reliability. To achieve this goal, innovative approaches to traditional processes need to take place. This webinar..
How to Implement an Effective Human Error Investigation Program
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrenc..
How to Write SOP’s for Human Error Reduction
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Procedures play a vital role in human reliability. Nevertheless, it is essential to understand human behavior and the psychology of error as well as underst..
Improve Your IRS Compliance: Use Best Practices for TIN Solicitation
This IRS regulatory compliance training will explain the Best TIN Solicitation Best Practices. While TIN solicitation might sound too lascivious for the legitimate business world, it is critical that every organization take this task seriously. For if they don't, a very uncomfortable and costly audit with the IRS is likely to ensue.Areas CoveredIdentify all required TIN information you need to collectDesign..
Mediating Construction Disputes – How To Be Successful
Mediation is not new. Mediation was employed in ancient India as well as in the Islamic world. In more recent times mediation has been widely adopted in the U.S. construction industry as a form of Alternative Dispute Resolution (ADR). Mediation is often employed when claims negotiations fail to reach a resolution in lieu of arbitration or litigation. The webinar discusses mediation as a process and discusse..
Navigating The US Customs Regulations - Title 19 Code of Federal Regulations
Having a solid understanding of applicable regulations is not only legally required, but it can also offer your company tactical and strategic advantages. Preventing fines, penalties, and potential loss of import privileges will keep your business running smoothly, efficiently, and at the lowest cost of operation. Knowing, understanding, and applying the subtle areas of trade compliance and global trade man..
New National Bioengineered Food Disclosure Act (GMO Food Labeling)
The new rule is highly anticipated by industry and will hopefully bring clarity to the long-standing GMO questions, cover financial and risk impact to businesses as well as helping consumers with educated food choices based on science, in short session encapsulates everything industry needs to know on launching the (NBFDSA).Learning Objectives Background on US GMO (Genetically Modified Organism) LabelingBas..