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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
Compliance with the New ICH GCP revised 2 Guidelines

Compliance with the New ICH GCP revised 2 Guidelines

  • Speaker: Laura Brown
  • Product ID: 704989
  • Duration: 60 Min
This New ICH GCP E6 Revision 2 changes will cover those new requirements for running clinical trials, evaluate the changes and discuss how to implement these for sponsors, CROs and study sites. This session will enable you to meet the new international GCP standard to ensure the acceptance of clinical trial data by the regulatory authorities internationally including the European Union (EU), Japan, the United States, Canada and Switzerland.
CD/Recorded
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Understanding the Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program

Understanding the Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program

  • Speaker: Charity Ogunsanya
  • Product ID: 705008
  • Duration: 90 Min
This webinar will help the attendee gain an understanding of the requirements of current USP <85> Bacterial Endotoxin Test (BET), European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia (General Tests, No. 4.01). The webinar will provide the attendee the ability to understand the different LAL testing methodologies, choosing the best test method applicable to the product type, criticality of the BET test result as it applies to the release of a cGMP manufactured product.
CD/Recorded
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Recorded/CD
Data Analysis in QSR

Data Analysis in QSR

  • Speaker: Daniel O Leary
  • Product ID: 704990
  • Duration: 90 Min
Data analysis is one of the most powerful improvement tools because it can lead to cost reductions and preventive action. To use these techniques you need to know both the regulatory requirements and the analysis framework. This webinar gives you the tools and techniques to implement an effective data analysis program.
CD/Recorded
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Recorded/CD
You Found an Objectionable Microorganism, Now What? Risk of presence of Objectionable Microorganisms in Biopharmaceuticals

You Found an Objectionable Microorganism, Now What? Risk of presence of Objectionable Microorganisms in Biopharmaceuticals

  • Speaker: Henry Urbach
  • Product ID: 702964
  • Duration: 60 Min
This webinar on objectionable microorganisms will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.
CD/Recorded
$229
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Recorded/CD
Selection and Management of Contract Vendors

Selection and Management of Contract Vendors

  • Speaker: Peggy Berry
  • Product ID: 704884
  • Duration: 90 Min
This webinar will discuss approaches to selecting vendors to perform manufacturing and testing activities as well as clinical study activities. The information obtained will enable implementation of an effective vendor selection program and a comprehensive vendor management and oversight program. The webinar will address aspects of requesting bids, performing audits, evaluating risks, and preparing plans and agreements for effective oversight and management.
CD/Recorded
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Recorded/CD
Mission to Mitigate: Preventing recalls and outbreaks by design

Mission to Mitigate: Preventing recalls and outbreaks by design

  • Speaker: Darin Detwiler
  • Product ID: 704966
  • Duration: 90 Min
This course is designed to bring food industry leaders up to speed with the latest in related policy characteristics. The goal is to enable industry leaders to better understand the food policy landscape.
CD/Recorded
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Recorded/CD
Life Cycle Risk Management for 21 CFR 820 and ISO 13485

Life Cycle Risk Management for 21 CFR 820 and ISO 13485

  • Speaker: Russell Pizzuto
  • Product ID: 704964
  • Duration: 90 Min
This webinar will present a Lifecycle Risk Management System that meets FDA and ISO requirements. That risk management system (based on ISO 14971) creates a closed loop system that identifies risks, and uses field use feedback to adjust risks and to improve designs and processes. The objective evidence produced by a Lifecycle Risk Management Systems can be used to demonstrate risk management compliance to 21 CFR Part 820 and ISO 13485.
CD/Recorded
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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.
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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
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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
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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
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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
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
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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.
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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
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