Quality Management
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..
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..
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..
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..
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..
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..
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 Set up an Internal Audit Program
An overview of how to set up an internal audit program to address quality management system standards, government regulations, risk management as well as usage for continuous improvement.This is especially useful for small to medium-sized medical device companies and start-up companies to ensure that all of the applicable regulatory requirements are incorporated into the system to ensure compliance with all..