ComplianceOnline

Quality Assurance and Quality Controls Training - Live Webinars, Recordings & CDs

Whether you are a quality assurance or a quality control professional, you know how the rapid transformations in regulatory requirements and technology are changing the nature of your work. We understand this challenge and have put together quality assurance and quality control courses to help you make your role robust-proof. Browse for the many courses, standards, and tools of specific interest to you.

Recorded/CD
How to Internal Audit to ISO 9001:2008

How to Internal Audit to ISO 9001:2008

  • Speaker: Rick Saldivar
  • Product ID: 701167
  • Duration: 60 Min
This ISO 9001:2008 training will provide an understanding of the changes and requirements that Internal Auditors in ISO 9001 certified organizations will need to address to be compliant to the new ISO 9001:2008 revision.
CD/Recorded
$199
Recorded/CD
Lean Six Sigma and Supply Chain: Convergence

Lean Six Sigma and Supply Chain: Convergence

  • Speaker: Ron Crabtree
  • Product ID: 701247
  • Duration: 90 Min
In this Lean six sigma training we will explore what early adopters are doing – and what is on the horizon and a brief history of the evolution both LSS (Lean Six Sigma) in SCM (Supply Chain Management).
CD/Recorded
$50
Recorded/CD
Aerospace -Transitioning to AS9100 Rev.C

Aerospace -Transitioning to AS9100 Rev.C

  • Speaker: Rick Saldivar
  • Product ID: 701166
  • Duration: 60 Min
This AS9100 compliance training will provide an understanding of the changes and requirements AS 9100 certified organizations will need to address to be compliant to the new AS9100 Revision C Standard.
CD/Recorded
$199
Recorded/CD
Critical Control Points (CCP’s). Where are they? Why? When?

Critical Control Points (CCP’s). Where are they? Why? When?

  • Speaker: Irwin Pronk
  • Product ID: 701180
  • Duration: 60 Min
This Food safety compliance training will explain the CCP Decision Tree and help you understand the principles behind each question. We will review various food processing steps in a variety of situations to determine whether they are CCP’s. What is the thought process in determining a CCP? Can it be done consistently? What criteria are used? Are some processing steps always CCP's e.g. heating? If not, why? One thing to remember is the importance of analyzing the hazards at each step very carefully. The more clearly the hazards are described (including equipment failures, personnel errors etc) the easier it will be to find the CCP.
CD/Recorded
$199
Recorded/CD
Setting up a Quality Management System (QMS)

Setting up a Quality Management System (QMS)

  • Speaker: Elizabeth E Bodi
  • Product ID: 701126
  • Duration: 60 Min
This Quality management training will cover principles of QMS that will help your organization implement a QMS that is repeatable and efficient.
CD/Recorded
$199
Recorded/CD
'Preventive Action' - the often ignored side of CAPA: Use FMEA to build preventive action into your CAPA program

'Preventive Action' - the often ignored side of CAPA: Use FMEA to build preventive action into your CAPA program

  • Speaker: Holly Duckworth
  • Product ID: 701152
  • Duration: 60 Min
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.
CD/Recorded
$199
Recorded/CD
Gage R & R - Improving the Reliability and Reducing the Variation of Your Measurement System

Gage R & R - Improving the Reliability and Reducing the Variation of Your Measurement System

  • Speaker: Vinny Sastri
  • Product ID: 701084
  • Duration: 60 Min
This Webinar will provide a basic and practical understanding of the method and will include both continuous and attribute test methods. All measurements have variation. Identifying the root causes and sources of this variation and finding ways to minimize the variation will result in test methods that one can use with high confidence to test and release acceptable products to the end-user. One of the most common methods used to assess a measurement system’s capability is the Gage Repeatability and Reproducibility (Gage R&R). It focuses on identifying and reducing the variation in the measurement system.
CD/Recorded
$299
Recorded/CD
Quality Expectations for Drugs and Biologics during Early Development: Phase 3 and NDA

Quality Expectations for Drugs and Biologics during Early Development: Phase 3 and NDA

  • Speaker: Steven S Kuwahara
  • Product ID: 701011
  • Duration: 75 Min
This presentation will discuss the quality-related activities that are expected for Phase 3 products used in clinical studies and the needs of the key demonstration lots that will be submitted with the NDA. This presentation will be aimed at helping Regulatory, Quality Assurance and Quality Control personnel to understand the varying levels of quality activities that accompany early stages of Product development.
CD/Recorded
$299
Recorded/CD
Quality Risk Management Using Failure Modes, Effects and Criticality Analysis

Quality Risk Management Using Failure Modes, Effects and Criticality Analysis

  • Speaker: Diane G Kulisek
  • Product ID: 701066
  • Duration: 60 Min
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.
CD/Recorded
$249
Recorded/CD
Quality Expectations for Drugs and Biologics during Early Development: Phase 2

Quality Expectations for Drugs and Biologics during Early Development: Phase 2

  • Speaker: Steven S Kuwahara
  • Product ID: 701010
  • Duration: 75 Min
This presentation will be aimed at helping Regulatory, Quality Assurance and Quality Control personnel to understand the varying levels of quality activities that accompany early stages of Product development. Emphasis will be placed on the transition into full GMP work as clinical trials proceed, but the requirements for NDAs (or BLAs) will be discussed.
CD/Recorded
$299
Recorded/CD
The Kaizen Event and how it can help improve your Quality Program

The Kaizen Event and how it can help improve your Quality Program

  • Speaker: Brad Snyder
  • Product ID: 700977
  • Duration:
Kaizen Events are an extremely efficient way to quickly improve process efficiencies and effectiveness.
CD/Recorded
$249
Recorded/CD
CAPA - Root cause and risk management

CAPA - Root cause and risk management

  • Speaker: Dr. Norman Howe
  • Product ID: 700997
  • Duration: 40 Min
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.
CD/Recorded
$149
Recorded/CD
CAPA Management and Compliance with Regulatory Requirements

CAPA Management and Compliance with Regulatory Requirements

  • Speaker: Bernice Russell Bond
  • Product ID: 700943
  • Duration: 75 Min
This regulatory training will provide benefits to companies’ required to have a process for collecting, assessing and documenting deviation and complaints and ensuring that corrective and preventive actions are compliant with GXP requirements.
CD/Recorded
$249
Recorded/CD
Effective CAPA Management: How to Implement a Risk-based Approach to Improve Your Quality System

Effective CAPA Management: How to Implement a Risk-based Approach to Improve Your Quality System

  • Speaker: Ken Peterson
  • Product ID: 700994
  • Duration:
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.
CD/Recorded
$249
Recorded/CD
Introduction to Process Capability (Cp, CpK, Pp, Ppk)

Introduction to Process Capability (Cp, CpK, Pp, Ppk)

  • Speaker: Lawrence Mucha
  • Product ID: 700342
  • Duration: 60 Min
This webinar will provide valuable assistance to all regulated companies that need to validate their systems In this session we will introduce basic control charting and statistical methods to determine if a process is capable of consistently producing product within specifications and how to make it capable if it is not
CD/Recorded
$299
Recorded/CD
Validation Requirements Based on ICH Q9

Validation Requirements Based on ICH Q9

  • Speaker: Jamie Jamshidi
  • Product ID: 700932
  • Duration: 90 Min
This program is specially designed for personnel in the Pharmaceutical and Biotechnology industries. This guidance provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.
CD/Recorded
$249
Recorded/CD
Quality Expectations for Product Development CMC Activities: R & D, GLP or GMP

Quality Expectations for Product Development CMC Activities: R & D, GLP or GMP

  • Speaker: Steven S Kuwahara
  • Product ID: 700949
  • Duration: 75 Min
This presentation will discuss the quality-related activities that are expected for different stages of the product development process. Emphasis will be placed on the transition into full GMP work as clinical trials proceed, but the requirements for DMFs and NDAs (or BLAs) will be discussed.
CD/Recorded
$299
Recorded/CD
Quality by Design: what the FDA wants, what you must do, how you can deliver to their expectations and what relief you can expect

Quality by Design: what the FDA wants, what you must do, how you can deliver to their expectations and what relief you can expect

  • Speaker: Peter Calcott
  • Product ID: 700893
  • Duration: 60 Min
This webinar will describe the origins and rationale for the QbD program. It will describe the successes in the generic and drug areas and the opportunities in the biologics areas. The fruits of the program can bring a higher success rate in the commercial operations with its impact on cost of goods, reduced reporting requirements or at least a reduction in the level of reporting for supplements and less complex or stressful inspections.
CD/Recorded
$249
Recorded/CD
The CAPA Trap or Common Problems and Pitfalls

The CAPA Trap or Common Problems and Pitfalls

  • Speaker: Jeff Phillips
  • Product ID: 700914
  • Duration: 60 Min
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.
CD/Recorded
$249
Recorded/CD
Lean Documents and Document Control

Lean Documents and Document Control

  • Speaker: Jose Mora
  • Product ID: 700331
  • Duration: 90 Min
This webinar presents key concepts on introducing lean principles, while maintaining a state of control and regulatory compliance Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents
CD/Recorded
$249
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