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Home › Online Training ›  QA/QC

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.
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Recorded/CD
FDA Inspection Preparedness

FDA Inspection Preparedness

  • Speaker: Susan Muhr Leister
  • Product ID: 704221
  • Duration: 60 Min
This training program will discuss key terms and responsibilities related to FDA inspections and the purpose of the BIMO inspection program. It will also review the general purpose and overall process of an FDA inspection and enhance your inspection preparation strategies.
CD/Recorded
$229
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Recorded/CD
FDA’s New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices

FDA’s New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices

  • Speaker: Angela Dunston
  • Product ID: 704431
  • Duration: 90 Min
This training program will provide a review of the current testing requirements and discuss what happened to the old 87/91 LAL Guidance for Industry proposed guidance. The program will also discuss how to transition from one bacterial endotoxin test to another—understanding the RPT (Rabbit Pyrogen Test). Participants will also gain a clearer perspective of the Monocyte Activation Test (MAT).
CD/Recorded
$179
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Recorded/CD
Creating Proper User Requirement Specifications (URS) for Computer Systems Validation (CSV) - Ensuring Overall Regulatory Compliance

Creating Proper User Requirement Specifications (URS) for Computer Systems Validation (CSV) - Ensuring Overall Regulatory Compliance

  • Speaker: Gaurav Walia
  • Product ID: 704370
  • Duration: 75 Min
This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.
CD/Recorded
$229
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Recorded/CD
Process Robustness: The New FDA Paradigm

Process Robustness: The New FDA Paradigm

  • Speaker: Angela Dunston
  • Product ID: 703990
  • Duration: 90 Min
In this training program, attendees will learn how process robustness tools and metrics can be utilized to enhance process understanding and control. The new FDA paradigm is shifting to the expectation that organizations certified by other standards such as ISO and EFfCI demonstrate process robustness. It is the obligation of the primary pharmaceutical provider to ensure process robustness throughout the supply chain.
CD/Recorded
$229
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Recorded/CD
Using Analysis of Variance - A Practical Approach

Using Analysis of Variance - A Practical Approach

  • Speaker: Daniel O Leary
  • Product ID: 703824
  • Duration: 60 Min
This training program will illustrate the underlying idea that makes ANOVA work. It will also offer an understanding of the data collection issues you should plan and how to get access to ANOVA in Excel.
CD/Recorded
$229
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Recorded/CD
How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment

How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment

  • Speaker: Michael Levin
  • Product ID: 704274
  • Duration: 60 Min
Among other key topics, this training program will focus on what can be monitored in mixing operations, wet granulation operations, dry granulation operations, compaction operations, and coating operations.
CD/Recorded
$229
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Recorded/CD
Preparing for FDA's Unique Device Identification Rule

Preparing for FDA's Unique Device Identification Rule

  • Speaker: Daniel O Leary
  • Product ID: 702594
  • Duration: 90 Min
This 90-minute webinar will review FDA's draft regulations for UDI and describe the new requirements for labeling medical devices. It covers the new regulations in 21 CFR Part 830, the changes to Part 820, the Quality System Regulation; Part 801, Labeling; Part 803, Medical Device Reporting; Part 806 Corrections and Removals; and other regulations.
CD/Recorded
$229
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Recorded/CD
Making Sense of BSCs, Hoods, Isolators, RABs

Making Sense of BSCs, Hoods, Isolators, RABs

  • Speaker: Joseph Winslow
  • Product ID: 704361
  • Duration: 60 Min
Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.
CD/Recorded
$229
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Recorded/CD
Critical Role of Quality Audit in GxP Compliance & Improvement

Critical Role of Quality Audit in GxP Compliance & Improvement

  • Speaker: David Dills
  • Product ID: 700982
  • Duration: 62 Min
This Webinar will address the key elements on being an effective auditor for your company covering the different types of audits, what do audits measure and how are audit results measured and certainly why perform audits to begin with. Learn the basic skills required and how to apply them and the knowledge in becoming more effective.
CD/Recorded
$299
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Recorded/CD
Record Keeping for a food Recall: Keeping Records to Minimize the Affect of a Recall

Record Keeping for a food Recall: Keeping Records to Minimize the Affect of a Recall

  • Speaker: Craig Nelson
  • Product ID: 701119
  • Duration: 60 Min
This Food safety training will provide valuable guidance to management, supervision, and quality staff that are involved with record keeping for product and ingredient traceability and recall.
CD/Recorded
$199
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Recorded/CD
Aerospace - transitioning to AS9100 Rev.C - Effect of Addition of Risk Management requirements

Aerospace - transitioning to AS9100 Rev.C - Effect of Addition of Risk Management requirements

  • Speaker: Rick Saldivar
  • Product ID: 701299
  • Duration: 75 Min
This AS9100 Rev.C training will cover the changes made in Rev.C and how it might impact your organization including the additional requirements associated with Risk Management.
CD/Recorded
$199
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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
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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
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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
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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
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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
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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
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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
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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
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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
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