Quality Management

$199.00
Understanding and Implementing a Quality by Design Program

 March 28 2024
 01 : 00 PM EST    
 60 Minutes
Understanding and Implementing a Quality by Design Program

The benefits of applying the QbD principles in the pharmaceutical industry have been well advertised. Most important are the direct benefits to our primary customer; the patient. Per Janet Woodcock M.D. Director, Center for Drug Evaluation and Research (CDER), Food and Drug Administration “All products are designed and developed to be of high quality; QbD provides a structured framework for developing, docu..

$199.00
 Issues in Calibrations and Accuracy in Method Validation

 April 17 2024
 01 : 00 PM EST    
 60 Minutes
Issues in Calibrations and Accuracy in Method Validation

Accuracy, the ability for a methodology to give results within acceptable limits when compared to known values, is a fundamental and key requirement. Calibration is the most common approach to obtain accuracy.Accuracy requires a comparison to a validated material. The level of confidence depends on traceability, a chain connecting the samples of interest all the way to the specific metric standards. This ca..

$199.00
Continues Improvements using 7 Basic Quality Tools

 April 22 2024
 03 : 00 PM EST    
 60 Minutes
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..

$199.00
Process, Process management and KPIs

 April 26 2024
 01 : 00 PM EST    
 90 Minutes
Process, Process management and KPIs

This webinar gives a fundamental knowledge of the process and its characteristics as a crucial step to increase the effectiveness and efficiency of your process and hence the overall business so you can increase the satisfaction level of your internal and external customers.After this webinar, participants will be able to define the boundaries of their processes, link them with pre and post-processes, and d..

$199.00
Validation Sampling Plans, Setting Acceptance Specifications and Statistical Process Control

 April 29 2024
 12 : 00 PM EST    
 60 Minutes
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..

$200.00
5S or 7S Lean Manufacturing and Workplace Organization – What Happened to 6S?

 Recorded Webinar
 60 Minutes
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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..

$200.00
Corrective and Preventive Action (CAPA) and Root Cause Analysis

 Recorded Webinar
 90 Minutes
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Corrective and Preventive Action (CAPA) and Root Cause Analysis

Recognize that CAPA is arguably the most important process in the quality management system because so much else depends on it. CAPA is used to handle not only poor quality (the traditional application) but also audit findings, customer complaints, and outputs of the management review. It can even be deployed against the other six Toyota production system wastes by treating them as "nonconformances" or, mor..

$200.00
Adaptive S & OP

 Recorded Webinar
 90 Minutes
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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 ..

$200.00
Artificial Intelligence and the Law

 Recorded Webinar
 60 Minutes
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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..

$200.00
Audit Trail Generation and Review

 Recorded Webinar
 90 Minutes
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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..

$200.00
Audit2020: Evolving the Internal Audit Process

 Recorded Webinar
 120 Minutes
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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..

$200.00
Best Practices for Using Your Quality Management System’s Quality Objectives and KPIs for Meaningful Process Improvement

 Recorded Webinar
 60 Minutes
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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..

$200.00
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

 Recorded Webinar
 90 Minutes
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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..

$200.00
Designing an Effective and Efficient Internal Audit Process for Your Quality Management System

 Recorded Webinar
 60 Minutes
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Designing an Effective and Efficient Internal Audit Process for Your Quality Management System

This webinar will focus on designing a thorough internal audit set of process tools, accurately captured in your internal audit procedure that will provide many years of payback and dividends for your organization. Areas CoveredUtilizing PDCA before your internal audits9.2.1 internal audit (general requirements)9.2.2 internal audit scope9.2.2 internal audit frequency9.2.2 internal audit methodsInternal Audi..

$200.00
Drafting Document Retention Policies

 Recorded Webinar
 60 Minutes
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Drafting Document Retention Policies

The presentation reviews the basic approach of Information Governance and the importance of getting the relevant stakeholders at the table when drafting a document retention policy. We discuss the importance of document destruction and how to develop a policy that balances the interests of the various stakeholders.Areas CoveredInformation GovernanceObjectivesPolicies and ProceduresRecords Retention and Dest..

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