Setting up a Quality Management System (QMS)
Elizabeth E Bodi
60 Min
Product Id: 701126
This Quality management training will cover principles of QMS that will help your organization implement a QMS that is repeatable and efficient.
'Preventive Action' - the often ignored side of CAPA: Use FMEA to build preventive action into your CAPA program
Holly Duckworth
60 Min
Product Id: 701152
This Quality management training will show you how to use methods you probably already have in place to create effective preventive action. Linking these on-going tools to your CAPA program will increase the benefit. Many organizations focus on improving root cause problem solving and tracking issues and corrective actions. That’s a good beginning to a CAPA program. But many organizations don’t effectively implement Preventive Action.
Quality Risk Management Using Failure Modes, Effects and Criticality Analysis
Diane G Kulisek
60 Min
Product Id: 701066
This webinar will provide valuable assistance to all FDA-regulated organizations seeking to implement Risk Management through effective FMECA efforts. Diane will also provide internet links to valuable on-line FMECA and Risk Management references as well as to downloadable FMEA templates for use with MS Excel in association with this presentation.
How to Establish Quality Objectives that Produce Results
Diane Bove
90 Min
Product Id: 700965
The webinar provides a comprehensive and logical way to think about performance goals, metrics and the evaluation of goal progress.
The Kaizen Event and how it can help improve your Quality Program
Brad Snyder
Product Id: 700977
Kaizen Events are an extremely efficient way to quickly improve process efficiencies and effectiveness.
CAPA - Root cause and risk management
Dr. Norman Howe
40 Min
Product Id: 700997
Participants will learn how to write CA reports that will be used as written & how a well maintained CAPA system will save the company time and money. This course summarizes the cGMP requirements for Corrective Action Preventive Action (CAPA) and prepares participants to complete CAPA investigations on their own.
How to Apply Lean Practices to the Production Process
Thomas Gray
60 Min
Product Id: 700979
This presentation will give organization information as to how to organize itself and create a Lean Project Plan to roll-out the various lean techniques. This Webinar will provide valuable assistance to all companies looking to identify and remove waste in processes and value streams.
Effective CAPA Management: How to Implement a Risk-based Approach to Improve Your Quality System
Ken Peterson
Product Id: 700994
In this course, we will introduce you to a new method of managing your CAPA system, The Gateway: A Risk-based Filter. This webinar is geared toward professionals in the QA/AC and CAPA discipline and is appropriate for individuals who are regularly called upon to resolve problems, or whose input would aid in preventing problems.
Designing an Effective and Efficient Internal Audit Process for Your Quality Management System
Michael A Mathe
60 Min
Product Id: 700170
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.
Security Standards ISO 27001 and 27002: What they are and how to use them
Diana Kelley,Ed Moyle
Product Id: 700868
In this webinar, ISO certified lead auditor for 27001, Ed Moyle, and Diana Kelley, Partner at Security Curve, will explain how organizations can use the ISO standards as a baseline for their security and risk management program. This webinar will provide valuable assistance to all companies are building and maintaining information security management systems.
Conducting Process Audits within both ISO 9001 and ISO 13485
Diane Bove
90 Min
Product Id: 700962
Emphasis is placed on conducting effective process auditing through an internal audit program within a company’s quality management system. This webinar is intended to review the requirements for determining if a company has its processes under control, with reviews of the requirements and description of the methods to determine which processes are expected to be audited.
ISO 17025 - The elements of good management system for the competence of testing and calibration in laboratories
Lawrence Mucha
60 Min
Product Id: 700919
This presentation will cover sections 4 and 5. These contain the requirements for accreditation. ISO 17025 “describes” the elements of a good management system for a laboratory. It also details the principles for a laboratory to ensure technical competence.
Process Mapping: A tool to generate process improvements
Sharon Gregory
60 Min
Product Id: 700917
The process mapping tool is presented to the participants in a clear and effective manner complemented by an array of relevant examples. This webinar will be valuable for any member of any industry desiring process improvements.
Problem Solving Using a Combination of Lean, Six Sigma and ISO 9001:2000 Tools
Michael A Mathe
60 Min
Product Id: 700330
Direct your organizations decision on whether to follow the ISO certification path or a Lean The purpose of this webinar will be to present how Lean - Six Sigma and quality management system problem
The CAPA Trap or Common Problems and Pitfalls
Jeff Phillips
60 Min
Product Id: 700914
The following webinar will cover common CAPA problems across industries and how to avoid them. This webinar will provide valuable assistance to all regulated companies that need to have CAPA systems as mandated by the FDA.
Six Sigma Methodology for Process Validation
Lawrence Mucha
90 Min
Product Id: 700340
This webinar will provide valuable assistance to all regulated companies that need to validate their systems The series will deal with Operational Qualification (OQ), Performance Qualification (PQ), and maintaining a state of validation using statistical methods associated with Six Sigma
Designing an Effective Audit Program
Deborah Donaldson
60 Min
Product Id: 700780
This webinar will provide valuable assistance to all regulated companies that need to audit any department, process or procedure, financial records, assets, etc. This program will look at the formation and interpretation of the ICQs, narratives, flowcharts, as well as the proper design for the audit steps.
'Performing effective supplier audits: a coming FDA compliance focus'
Dennis Moore
60 Min
Product Id: 700436
his presentation will cover auditing and management techniques in relation to purchasing control compliance. Real supplier auditing processes and other management tools associated with purchasing controls will be discussed Many firms feel that they are adequately auditing and managing suppliers, yet find they are having myriads of quality issues. FDA and other auditing organizations are going to focus on supplier auditing compliance in 2007-2008
Suggestions for individuals to check and safeguard confidential data
Deborah Donaldson
60 Min
Product Id: 700634
This webinar focuses on the regulatory requirements surrounding this issue, steps that a company can take to mitigate the risk of loss or exposure, and ways that consumers can participate in the protection of their own information. This webinar will provide valuable assistance to all regulated companies that need to safeguard confidential customer data.
Developing a Robust CAPA System
Ronald Schoengold
60 Min
Product Id: 700550
In this webinar instructor will explain what are essential elements of CAPA system to meet current regulatory requirement and how to achieve it The basic CAPA procedure should clearly define the fundamental elements for developing CAPA files which address significant quality system non-conformances







