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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
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
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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
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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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Recorded/CD
Biological Indicators for Sterilization Performance Qualification

Biological Indicators for Sterilization Performance Qualification

  • Speaker: Aaron Mertens
  • Product ID: 704879
  • Duration: 90 Min
This webinar will focus on biological indicator usage for sterilization performance qualification in the pharmaceutical and biotech industry. Biological indicator preparation, including population and D-value resistance determination, is presented in depth. Understanding these details is critical to successfully choose a biological indicator and qualify a sterilization process.
CD/Recorded
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Recorded/CD
Preventing Product Liability Lawsuits and Recalls - New Product Development

Preventing Product Liability Lawsuits and Recalls - New Product Development

  • Speaker: Randall Goodden
  • Product ID: 704780
  • Duration: 60 Min
The largest cause of recalls which will normally lead to product liability lawsuits is “Defects in Design.” The product’s design specification was defective right from the start, which wasn’t caught or handled properly, and then manufacturing management made sure all the products were manufactured per that [defective] specification. This training program will briefly cover all the procedures that need to be in place and followed during new product development.
CD/Recorded
$249
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Recorded/CD
Objections to Agile and what you can do about them?

Objections to Agile and what you can do about them?

  • Speaker: Brian Shoemaker,Nancy Van Schooenderwoert
  • Product ID: 704872
  • Duration: 60 Min
This webinar will review the classic objections to Agile practices and explain how to overcome them. We will discuss real-world examples of medical device companies currently employing Agile approaches and understand how you or your company can gain similar benefits.
CD/Recorded
$229
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Recorded/CD
Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing

Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing

  • Speaker: Henry Urbach
  • Product ID: 702634
  • Duration: 60 Min
This 60-minute webinar will show how you can design a robust microbiological audit program for pharmaceutical and biopharmaceutical product manufacturing, that effectively assesses your facility and that of your supplier to ensure your facilities and products are free from microbial contamination.
CD/Recorded
$229
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Recorded/CD
Steam Sterilization Microbiology and Autoclave Performance Qualification

Steam Sterilization Microbiology and Autoclave Performance Qualification

  • Speaker: Aaron Mertens
  • Product ID: 704850
  • Duration: 90 Min
This webinar will discuss the regulatory and GMP requirements for steam sterilization and the mechanism as it relates to bacterial cells and endospores. The training will cover autoclave performance qualification studies and the tools to be used.
CD/Recorded
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Recorded/CD
FDA Regulation, 3D Printing and Medical Devices

FDA Regulation, 3D Printing and Medical Devices

  • Speaker: Rachelle D Souza
  • Product ID: 704846
  • Duration: 75 Min
This webinar on 3D printing will cover FDA's expectations regarding the design, manufacture, testing and approval of 3D printed medical devices.
CD/Recorded
$229
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Recorded/CD
Extractables and Leachables - Biopharma Polymeric Devices

Extractables and Leachables - Biopharma Polymeric Devices

  • Speaker: Mark Trotter
  • Product ID: 704798
  • Duration: 90 Min
This webinar training will examine the key topics concerning the use of polymeric single-use products in biopharm processes. It will offer a basic understanding of industry standards and regulatory compliance. The training program is designed for the experienced as well as those new to biopharmaceutical processes and need to know current requirements for determination of extractables and leachables in biopharm processes.
CD/Recorded
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Recorded/CD
Managing SOP Compliance per FDA Regulations

Managing SOP Compliance per FDA Regulations

  • Speaker: Danielle DeLucy
  • Product ID: 704797
  • Duration: 60 Min
This training program will discuss formatting SOPs, FDA expectations for written documents and regulatory requirements, and the roles and responsibilities of authors and reviewers of SOPs. The program will also overview how to ensure a system for the control, archival, and disposal of written procedures.
CD/Recorded
$0
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Recorded/CD
FSMA Gives FDA Fee Collection Authority for Certain Violations

FSMA Gives FDA Fee Collection Authority for Certain Violations

  • Speaker: Ralph A Simmons
  • Product ID: 704787
  • Duration: 90 Min
FSMA has modified the traditional position that FDA would not collect fees from food companies to allow collection of the agency’s costs of remedying certain violations of food law. This training program will offer a background on FDA imposition of fees on food producers, the fee amount, and how it applies to small businesses.
CD/Recorded
$199
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Recorded/CD
Overview of Life Cycle of an Analytical Method in Development and Manufacture of Biologics

Overview of Life Cycle of an Analytical Method in Development and Manufacture of Biologics

  • Speaker: Rajesh Gupta
  • Product ID: 704755
  • Duration: 60 Min
This training program will offer an understanding of analytical method life cycle and regulatory expectations and requirements for the methods during product development. The webinar will also analyze risks and inherent variability of analytical methods.
CD/Recorded
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Recorded/CD
Renovation of Aging Aseptic and Biological Facilities

Renovation of Aging Aseptic and Biological Facilities

  • Speaker: Erich Bozenhardt
  • Product ID: 704789
  • Duration: 60 Min
In this training program, attendees will explore modern technologies, process changes and smart architectural design that can extend the useful life of manufacturers' aseptic and biologic facilities by 10 to 20 years. These upgrades can also make facilities more compliant, cut down on operating risks, and improve performance.
CD/Recorded
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Recorded/CD
Preparation for GMP Inspections by Regulatory Agencies

Preparation for GMP Inspections by Regulatory Agencies

  • Speaker: Peggy Berry
  • Product ID: 704843
  • Duration: 90 Min
This GMP inspections webinar will review what to expect during the agency inspection and how to successfully and efficiently streamline and manage the inspection, including adequate follow-up during and after the inspection.
CD/Recorded
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Recorded/CD
Comparing the Pharmaceutical and Medical Device Product Lifecycles

Comparing the Pharmaceutical and Medical Device Product Lifecycles

  • Speaker: Howard Cooper
  • Product ID: 704853
  • Duration: 120 Min
This webinar will help you gain a greater understanding of regulatory and compliance requirements and how the early product lifecycle requirements establish the basic groundwork as a foundation from product development to commercialization continuing to out commercialization and product discontinuation.
CD/Recorded
$249
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Recorded/CD
Understanding the Full Realm of Product Liability

Understanding the Full Realm of Product Liability

  • Speaker: Randall Goodden
  • Product ID: 704743
  • Duration: 60 Min
This training program will highlight all the key areas that need to be under control or can lead to product recalls, product liability lawsuits, and the causes of these economic disasters for manufacturing corporations.
CD/Recorded
$0
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Recorded/CD
Lyophilization: What you Need to Know, Validation and Regulatory Approaches

Lyophilization: What you Need to Know, Validation and Regulatory Approaches

  • Speaker: John R Godshalk
  • Product ID: 704845
  • Duration: 60 Min
In this webinar, attendees will learn how lyophilization cycles are developed, how lyophilizers work and how they are controlled and what is important to FDA and other regulatory bodies in the inspection of lyophilizers and in the validation process.
CD/Recorded
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Recorded/CD
ISO 9001:2015 Transition Overview

ISO 9001:2015 Transition Overview

  • Speaker: Kevin Gholston
  • Product ID: 704781
  • Duration: 90 Min
The new ISO 9001:2015 requires companies to establish context of the organization and utilize this perspective along with the new High Level Structure (HLS) Clauses. This webinar is designed for quality assurance managers, management representatives, ISO 9001 implementation teams, and quality management system auditors. With the release of ISO 9001:2015 in September 23, 2015, now is the time to prepare. This 9001-2015 Transition Overview course will highlight the changes from the ISO 9001:2008 revision.
CD/Recorded
$249
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