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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
Integrating Pharmacovigilance and Technical Complaint Systems

Integrating Pharmacovigilance and Technical Complaint Systems

  • Speaker: David L Chesney
  • Product ID: 704956
  • Duration: 90 Min
This webinar will discuss the FDA requirements for pharmacovigilance and complaint evaluation under GMP
CD/Recorded
$0
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Recorded/CD
FDA & CFIA 2016 Regulatory Changes/Updates Since ACE | Make Sure Your Business is Updated

FDA & CFIA 2016 Regulatory Changes/Updates Since ACE | Make Sure Your Business is Updated

  • Speaker: Grant Smith
  • Product ID: 704621
  • Duration: 90 Min
This training program will cover the 2016 regulatory changes and updates for the FDA (US Food and Drug Administration) and the CFIA (Canadian Food Inspection Agency). The program will also discuss updated product code classifications, license requirements for SFCA/CFIA, Automated Import Reference System updates and latest product marking requirements.
CD/Recorded
$199
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Recorded/CD
Device Design and Risk Management

Device Design and Risk Management

  • Speaker: Daniel O Leary
  • Product ID: 704561
  • Duration: 90 Min
As medical device requirements and expectations increase, coupled with strengthened standards, the design project must seek every opportunity to leverage activities in the area to satisfy requirements in other areas. This reduces the total work and helps make these processes more efficient. By attending this presentation, you will learn techniques to improve your device design project.
CD/Recorded
$0
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Recorded/CD
Prove 21 CFR 820 Compliance Using Requirements Traceability

Prove 21 CFR 820 Compliance Using Requirements Traceability

  • Speaker: Russell Pizzuto
  • Product ID: 704935
  • Duration: 90 Min
This webinar will demonstrate how to use requirements tractability to systematically connect Engineering, Manufacturing and Risk Management processes, and how to systematically collect the objective evidence necessary to prove 21 CFR 820 compliance to the FDA.
CD/Recorded
$0
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Recorded/CD
Critical Elements of Quality Risk Management Relating to FDA Compliance

Critical Elements of Quality Risk Management Relating to FDA Compliance

  • Speaker: Danielle DeLucy
  • Product ID: 704829
  • Duration: 60 Min
This training program will discuss risk management and outline the requirements for applying risk management to the quality system. It will also discuss how to conduct and implement risk management practices at your firm and review communication techniques to highlight the benefits of risk management.
CD/Recorded
$0
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Recorded/CD
Providing DMFs in eCTD format

Providing DMFs in eCTD format

  • Speaker: Peggy Berry
  • Product ID: 704934
  • Duration: 90 Min
This webinar will review the CTD format and content requirements for the DMF. It will discuss the transition from other formats to the CTD/eCTD and technical requirements for eCTD submission.
CD/Recorded
$0
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Recorded/CD
Implementing the New Usability Engineering Standard

Implementing the New Usability Engineering Standard

  • Speaker: Daniel O Leary
  • Product ID: 704894
  • Duration: 90 Min
Usability Engineering has become a major topic. The current standard tightens the linkage to risk management. In addition, there are changes in the US and EU approach, all of which find a basis in this standard. Attending this presentation provides the information you need to prepare for these major changes.
CD/Recorded
$279
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Recorded/CD
Validation Master Planning - The Unstated Requirements

Validation Master Planning - The Unstated Requirements

  • Speaker: John E Lincoln
  • Product ID: 704292
  • Duration: 90 Min
This training program will focus on U.S. FDA and EU's MDD expect documented risk-based VMP planning, though the CGMPs mention little about it. The course will analyze product V&V versus process/ equipment V&V and how to use DQ, IQ, OQ, PQ, and ASTM E2500 equivalents.
CD/Recorded
$279
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Recorded/CD
Creating Effective SOPs for Regulatory Compliance

Creating Effective SOPs for Regulatory Compliance

  • Speaker: Henry Urbach
  • Product ID: 702999
  • Duration: 60 Min
This FDA documentation webinar will explain the regulatory expectations for, and the proper design and maintenance of effective and compliant standard operating procedures (SOPs).
CD/Recorded
$169
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Recorded/CD
4-hr Virtual Seminar: The Quality Manual Ensuring Regulatory Requirements

4-hr Virtual Seminar: The Quality Manual Ensuring Regulatory Requirements

  • Speaker: Howard Cooper
  • Product ID: 704915
  • Duration: 4 hrs
This 4-hr webinar will focus on product lifecycle concepts that are applicable to all of the FDA regulated industries. Learn the objectives, purpose and scope of the quality manual and how to can be adapted to each different business environment.
CD/Recorded
$0
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Recorded/CD
The FDA Compliance Enforcement Process

The FDA Compliance Enforcement Process

  • Speaker: David L Chesney
  • Product ID: 704913
  • Duration: 90 Min
This 90 mins webinar will provide a thorough understanding of the range of FDA enforcement options and the criteria the agency applies in deciding which to use.
CD/Recorded
$0
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Recorded/CD
Integrating ISO 14971 Risk Analysis into the Product Development Process

Integrating ISO 14971 Risk Analysis into the Product Development Process

  • Speaker: Russell Pizzuto
  • Product ID: 704926
  • Duration: 90 Min
This Webinar will present the best practices for integrating medical device risk analysis into a quality system. This integrated processes spans new product development, design change, production, and post market surveillance for the lifecycle of the device. Objective evidence produced by the integrated processes can be used to demonstrate risk analysis compliance to 21 CFR 820 and ISO 14971 during an audit.
CD/Recorded
$249
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Recorded/CD
Type 2 DMFs for Active Pharmaceutical Ingredients (APIs)

Type 2 DMFs for Active Pharmaceutical Ingredients (APIs)

  • Speaker: Peggy Berry
  • Product ID: 704882
  • Duration: 90 Min
This webinar will discuss approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in the Drug Master File – in support of Module 3 of a CTD application. The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. Both traditional and enhanced approaches are discussed.
CD/Recorded
$0
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Recorded/CD
USP Hot Topics: What's Hot Now and How to Track Coming Changes and Influence USP

USP Hot Topics: What's Hot Now and How to Track Coming Changes and Influence USP

  • Speaker: Gregory Martin
  • Product ID: 703521
  • Duration: 90 Min
This webinar will provide insight into some of the hottest topics at USP which will have the greatest impact on pharmaceutical laboratories. It will provide a comprehensive overview of the major changes in the USP that have been proposed or implemented in the last year and describe strategies for keeping abreast of coming changes and how you can influence them.
CD/Recorded
$249
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Recorded/CD
Overview of the Mexican Labeling Standards and the New Labeling Requirements

Overview of the Mexican Labeling Standards and the New Labeling Requirements

  • Speaker: Sergio Ernesto Gutierrez
  • Product ID: 704904
  • Duration: 90 Min
In this 90 minutes session, attendees will learn the Mexican labeling standard as well as and the new requirements regarding the use of Front of Pack icons and the voluntary nutritional quality seal.
CD/Recorded
$229
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Recorded/CD
Problem Solving using DMAIC

Problem Solving using DMAIC

  • Speaker: Mercedes Massana
  • Product ID: 704807
  • Duration: 60 Min
This webinar will provide an introduction into the DMAIC problem solving process and will show how DMAIC can be utilized to ensure that any process which requires an investigation to be performed can be thoroughly addressed and well documented.
CD/Recorded
$0
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Recorded/CD
Creating the ISO 14971:2007: Developing the Risk Management File

Creating the ISO 14971:2007: Developing the Risk Management File

  • Speaker: Daniel O Leary
  • Product ID: 704855
  • Duration: 90 Min
This presentation gives you the essential information you need to write a successful plan. Many companies try to implement Risk Management using an inadequate Risk Management Plan. They often leave out required items or add additional, but unnecessary information. The Risk Management Plan is key to an efficacious project to ensure your device is safe and meets the regulatory requirements.
CD/Recorded
$0
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Recorded/CD
Learning Design Controls through review of FDA 483 Observations

Learning Design Controls through review of FDA 483 Observations

  • Speaker: Mercedes Massana
  • Product ID: 704805
  • Duration: 75 Min
This webinar will provide participants with key knowledge of medical device design controls by analyzing FDA 483 observations and learning what the agency is looking for with respect to each design control element.
CD/Recorded
$229
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Recorded/CD
ISO 9001:2015 Risk Based Thinking Training

ISO 9001:2015 Risk Based Thinking Training

  • Speaker: Kevin Gholston
  • Product ID: 704801
  • Duration: 120 Min
With the release of ISO 9001:2015 September 23, 2015, now is the time to prepare. This 9001-2015 Risk Based Thinking training program will highlight the changes from the ISO 9001:2008 revision. A key change is the addition of risk based thinking, and the training includes group exercises to reinforce this new process.
CD/Recorded
$0
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Recorded/CD
Simulation and Monte Carlo Analysis

Simulation and Monte Carlo Analysis

  • Speaker: Daniel O Leary
  • Product ID: 704856
  • Duration: 90 Min
Simulations and Monte Carlo methods are powerful tools in quality improvement. They can help explore proposed changes to methods and processes and avoid potential problems. They can also help optimize QMS activities. In this presentation, attendees learn methods in Excel, which means that projects do not need special purpose and expensive software packages.
CD/Recorded
$249
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