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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
Combination Products - The FDA's New Codifications of the cGMP Requirements Applicable to Combination Products

Combination Products - The FDA's New Codifications of the cGMP Requirements Applicable to Combination Products

  • Speaker: Angela Dunston
  • Product ID: 704623
  • Duration: 120 Min
This training program will analyze the general considerations for cGMP compliance and review the cGMP requirements in 21 CFR 4.4(b). The program will also discuss applications of cGMP requirements for specific types of combination products.
CD/Recorded
$0
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Recorded/CD
Single-Use Systems and Technologies

Single-Use Systems and Technologies

  • Speaker: Mark Trotter
  • Product ID: 704609
  • Duration: 90 Min
This training program will examine the many facets of disposable bioprocessing systems that incorporate a wide scope of polymeric single-use products. Single-use disposable technologies, from upstream to downstream processes, will be reviewed as related to the use of polymeric devices. Specific attention will be given to the related applications used in the production of biopharmaceuticals and pharmaceuticals.
CD/Recorded
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Recorded/CD
2 Ways to Look at Vulnerability Assessments - Part 1 and Part 2

2 Ways to Look at Vulnerability Assessments - Part 1 and Part 2

  • Speaker: Ned Mitenius
  • Product ID: 704471
  • Duration: 60 Min
This training program is designed for food defense and food safety practitioners who are preparing for implementation of the Intentional Adulteration rule. Those who have existing Food Defense Plans should understand how the vulnerability assessment requirements may go beyond most existing food defense plans and what considerations will be needed to comply with the rule. Operations which have relied on the FDA supplied Food Defense Plan Builder software tool should know the limitations of the existing tool, and how to overcome them, and who is qualified to do so.
CD/Recorded
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Recorded/CD
Technology Transfer and Validation for Medical Devices and Pharmaceuticals: The Link between Development, Validation and Commercial Production

Technology Transfer and Validation for Medical Devices and Pharmaceuticals: The Link between Development, Validation and Commercial Production

  • Speaker: Carlos Rodriguez Garcia
  • Product ID: 704248
  • Duration: 60 Min
The parallel requirements for medical devices and pharmaceuticals are incorporated into this comprehensive webinar that delineates the foundation for technology transfer and validation, encompassing regulatory requirements and voluntary guidance.
CD/Recorded
$279
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Recorded/CD
FDA Vs Health Canada

FDA Vs Health Canada

  • Speaker: Angela Dunston
  • Product ID: 703970
  • Duration: 60 Min
This training program will elucidate the similarities and differences between the FDA and Health Canada promulgations of regulations impact preparation. The course will also offer a review of the background and history behind the FDA and Health Canada.
CD/Recorded
$249
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Recorded/CD
Successful Deviation Investigations

Successful Deviation Investigations

  • Speaker: Danielle DeLucy
  • Product ID: 704596
  • Duration: 60 Min
This training program will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. This webinar will focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Attendees will learn how to identify and avoid potential pitfalls during deviation investigations.
CD/Recorded
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Recorded/CD
Best Practices in Being ‘On Call’ for FDA Submission Audits in the CDISC Programming Environment

Best Practices in Being ‘On Call’ for FDA Submission Audits in the CDISC Programming Environment

  • Speaker: Sunil Gupta
  • Product ID: 704594
  • Duration: 75 Min
This training program will assist anyone directly or indirectly responsible for the creation, content or validation of SDTMs, ADaMs, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. It will help attendees in determining how well your company is positioned to defend your FDA submission.
CD/Recorded
$0
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Recorded/CD
Creating FDA-compliant cGMP Training Program

Creating FDA-compliant cGMP Training Program

  • Speaker: Henry Urbach
  • Product ID: 703401
  • Duration: 60 Min
This webinar will explain how to implement an effective and FDA compliant GMP training program. It will discuss regulatory requirements and expectations for a well-trained workforce.
CD/Recorded
$179
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Recorded/CD
Pre-Market Submission Implications of FDA’s Human Factors Guidance and Device Priority List

Pre-Market Submission Implications of FDA’s Human Factors Guidance and Device Priority List

  • Speaker: Robert A North
  • Product ID: 704551
  • Duration: 90 Min
This training program will explore why human factors has become a vital part of the FDA’s medical device pre-market approval/clearance process. The FDA Center for Devices and Radiological Health (CDRH) recently issued two guidance documents on human factors that are key elements in determining pre-market submission strategies for manufacturers. In this webinar, attendees will learn how to provide clear and complete human factors submissions meeting the intent of these guidance.
CD/Recorded
$229
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Recorded/CD
Preparing for a UDI Implementation

Preparing for a UDI Implementation

  • Speaker: Lena Cordie Bancroft
  • Product ID: 704579
  • Duration: 90 Min
This training program will help attendees understand the requirements of the FDA UDI regulation and the labeling requirements of the UDI regulation. The program will also focus on data elements that make up a UDI compliant barcode and GUDID data attributes and submission process.
CD/Recorded
$0
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Recorded/CD
Implementation of Rapid Microbial Methods for Air and Water Monitoring in Pharmaceutical Industry

Implementation of Rapid Microbial Methods for Air and Water Monitoring in Pharmaceutical Industry

  • Speaker: Igor Gorsky
  • Product ID: 704560
  • Duration: 2 hrs
This training program will dispel mistaken paradigms regarding the risk based approach to introduction of rapid microbial detection systems for water systems. Attendees will understand how to validate and transfer LIF method and how to validate LIF instrument against currently used methods.
CD/Recorded
$0
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Recorded/CD
Biological Facility Design: Design for Compliance

Biological Facility Design: Design for Compliance

  • Speaker: Erich Bozenhardt
  • Product ID: 704576
  • Duration: 60 Min
This training program will explore the ABCs of facilities enhancement – compliance-driven actions that get results. It will also discuss devising and implementing a bullet-proof plan to reach goals, set expectations, and lower costs.
CD/Recorded
$229
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Recorded/CD
Food Defense - Is your organization safe?

Food Defense - Is your organization safe?

  • Speaker: Jason Teliszczak
  • Product ID: 703271
  • Duration: 60 Min
This food defense webinar will detail what an organization needs to have in place in order to safely manufacture, package, and or handle food products. It will cover a broad range of production types, facilities, and the transportation of goods. This webinar will highlight key areas of the organization that need to be controlled to ensure that intentional contaminants do not enter the product by potential threats.
CD/Recorded
$199
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Recorded/CD
Risk Based Design Control

Risk Based Design Control

  • Speaker: Edwin Waldbusser
  • Product ID: 704548
  • Duration: 60 Min
This training program will explain how to manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. The program will also help in getting projects completed on time and within budget.
CD/Recorded
$0
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Recorded/CD
Extractables and Leachables Testing for Polymeric Materials Used in Pharmaceutical Industry: An Introduction and Strategies in Current Practice

Extractables and Leachables Testing for Polymeric Materials Used in Pharmaceutical Industry: An Introduction and Strategies in Current Practice

  • Speaker: Armin Hauk
  • Product ID: 704340
  • Duration: 60 Min
This training program will offer participants an understanding of the concept of E&L (Extractables and Leachables) studies and about developing an E&L study in a reasonable and pragmatic way - based on regulatory requirements, guidelines and recommendations.
CD/Recorded
$169
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Recorded/CD
US, EU, Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

US, EU, Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

  • Speaker: Robert J Russell
  • Product ID: 704587
  • Duration: 90 Min
This 90-minute webinar will help you gain a comprehensive understanding of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will prepare you for regulatory inspections in these countries.
CD/Recorded
$229
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Recorded/CD
Methods for Detecting Mycoplasma Contamination in the Manufacture of Pharmaceuticals and Biologics

Methods for Detecting Mycoplasma Contamination in the Manufacture of Pharmaceuticals and Biologics

  • Speaker: Michael Simonian
  • Product ID: 704185
  • Duration: 90 Min
This training program will help attendees understand the sources of mycoplasma contamination and how to minimize the occurrence of contamination. The regulatory standards for testing will be described as well as the methods of mycoplasma detection and the resources for testing. At the conclusion of this webinar, attendees will have knowledge of the importance of mycoplasma contamination testing and how to successfully perform the tests in their company’s setting.
CD/Recorded
$249
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Recorded/CD
Integration of ERP and Legacy FDA-Regulated Systems

Integration of ERP and Legacy FDA-Regulated Systems

  • Speaker: Carolyn Troiano
  • Product ID: 704547
  • Duration: 60 Min
This training program will assist those responsible for planning, executing or managing the integration of a business system with any laboratory system governed by FDA regulations. On completing the program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, and how they apply to any integrated business system.
CD/Recorded
$0
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Recorded/CD
Monitoring for the FSMA Proposed Rule on Intentional Contamination

Monitoring for the FSMA Proposed Rule on Intentional Contamination

  • Speaker: Ned Mitenius
  • Product ID: 704451
  • Duration: 60 Min
The program will discuss the practical development of an adequate monitoring program optimized to fit the Intentional Adulteration Rule. Attendees will learn the difference between monitoring, verification and validation. The program will review the existing Food Defense Plan Builder tool including its limitations and some possible changes. In the absence of a provided tool, the program participants will be shown how to create an effective monitoring program, and the documentation required to support it.
CD/Recorded
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Recorded/CD
Worksheets that Capture SOP Details and Are Compliant

Worksheets that Capture SOP Details and Are Compliant

  • Speaker: Edward O Connor
  • Product ID: 704532
  • Duration: 60 Min
This training program will focus on understanding the drivers and benefit of using worksheets not only as a prompt for recording details but also in reducing efforts of the analysts and auditors in a GLP/GCP bioanalytical lab.
CD/Recorded
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