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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
Packaging and Labeling for Commercial and Clinical Products

Packaging and Labeling for Commercial and Clinical Products

  • Speaker: Peggy Berry
  • Product ID: 704378
  • Duration: 90 Min
This training program will discuss optimizing your packaging design for commercial and clinical products and translating a protocol into effective packaging design. Attendees will learn how to implement an effective artwork change management system. Real-life case studies and dos/don’ts for packaging and labeling for commercial and clinical products will also be discussed.
CD/Recorded
$279
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Recorded/CD
Strategies to Conduct a Successful Method Transfer according to FDA Expectations

Strategies to Conduct a Successful Method Transfer according to FDA Expectations

  • Speaker: Kim Huynh-Ba
  • Product ID: 705059
  • Duration: 90 Min
This webinar discusses how to execute meaningful Method Transfers by selecting appropriate analytical performance characteristics and acceptance criteria, documentation of the transfer process and how to avoid failures.
CD/Recorded
$0
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Recorded/CD
Implementing a Modern Pharmaceutical Quality System

Implementing a Modern Pharmaceutical Quality System

  • Speaker: Steven Laurenz
  • Product ID: 705055
  • Duration: 60 Min
This presentation explores the basic concepts making up an ICH Q10 Quality System approach and steps to properly implement the concepts.
CD/Recorded
$0
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Recorded/CD
Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

  • Speaker: Henry Urbach
  • Product ID: 705072
  • Duration: 90 Min
This webinar you will discuss how to help your organization get a better handle on what is an “objectionable microorganism, ” exactly how “objectionable” it really is and what you can do to minimize the risk if you find one in your process or product.
CD/Recorded
$249
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Recorded/CD
Risk-based Approach to Biopharmaceutical Method Transfers

Risk-based Approach to Biopharmaceutical Method Transfers

  • Speaker: Jeffrey Staecker
  • Product ID: 705049
  • Duration: 60 Min
This Webinar will discuss how non-compendial biopharmaceutical analytical method transfers can leverage a risk-based approach to address Quality and Regulator concerns. Method transfers using a statistical equivalence approach with tight criteria as frequently suggested by regulators makes it difficult to transfer methods and can result in a high transfer failure rate.
CD/Recorded
$0
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Recorded/CD
Compliance with Brexit's Impact on the Global Pharmaceutical industry

Compliance with Brexit's Impact on the Global Pharmaceutical industry

  • Speaker: Laura Brown
  • Product ID: 705047
  • Duration: 60 Min
Pharmaceutical companies will need to develop strategies for their drug programmes to deal with Brexit. This webinar will provide an essential understanding to help develop a strategy for managing Brexit.
CD/Recorded
$0
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Recorded/CD
Quality by Design

Quality by Design

  • Speaker: Heath Rushing
  • Product ID: 705051
  • Duration: 60 Min
This training program will guide attendees in implementing QbD principles from discovery through product discontinuation. It will also illustrate applying statistics to set specifications and validate measurement systems (assays) and discuss utilizing risk management tools to identify and prioritize potential critical process parameters.
CD/Recorded
$0
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Recorded/CD
Reimbursement Requirements for Designing Innovative Devices

Reimbursement Requirements for Designing Innovative Devices

  • Speaker: Tom Kramer
  • Product ID: 704625
  • Duration: 60 Min
This training program will highlight key metrics needed to convince reimbursement panels of design compliance and discuss how best to implement practices in your development process that ensure acceptance by reimbursement groups.
CD/Recorded
$0
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Recorded/CD
Audits - Seven reasons they don't work

Audits - Seven reasons they don't work

  • Speaker: Susanne Manz
  • Product ID: 705042
  • Duration: 90 Min
Continuous Improvement starts with awareness of issues and opportunities. And without an effective internal audit program, management lacks awareness of the issues within their quality system. Management is blind to the gaps in the quality system and the risk that poses for the company. Even worse, management is blind to the impact on product quality and risk to the customer. This webinar will highlight red-flags and ways reduce compliance and quality risk.
CD/Recorded
$0
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Recorded/CD
Phase I First-in-Man Studies: What is Special About How and Where These Trials are Conducted?

Phase I First-in-Man Studies: What is Special About How and Where These Trials are Conducted?

  • Speaker: Charles H Pierce
  • Product ID: 704842
  • Duration: 90 Min
This webinar will discuss the expectations of Phase 1 'First-in-Man' clinical studies, contrast the testing of pharmacokinetics and pharmacodynamics, differentiate safety testing in Phase 1 and 3 and describe the process of establishing the starting dose.
CD/Recorded
$50
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Recorded/CD
Perceptions of The Health Risks of Cosmetics, and What it means to Their Regulation

Perceptions of The Health Risks of Cosmetics, and What it means to Their Regulation

  • Speaker: Rob Ross Fichtner
  • Product ID: 704955
  • Duration: 90 Min
This webinar will discuss some of the major issues in the regulation of cosmetics. Upon completion of the session attendees will learn how regulators regulate cosmetics compared to other categories, fine line between cosmetics and drugs, and future directions for cosmetic regulations.
CD/Recorded
$179
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Recorded/CD
How the Food Safety Modernization Act Affects USDA Regulated Facilities

How the Food Safety Modernization Act Affects USDA Regulated Facilities

  • Speaker: Derrick Swint
  • Product ID: 705032
  • Duration: 90 Min
This FSMA webinar will outline key objectives for the meat and poultry industry to better understand what steps must be taken by food producers in this sector to meet, and preferably exceed, all relevant standards and regulations of the Food Safety Modernization Act (FSMA).
CD/Recorded
$0
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Recorded/CD
Basic Concepts of Sterility Assurance

Basic Concepts of Sterility Assurance

  • Speaker: Mark Seybold
  • Product ID: 705046
  • Duration: 90 Min
This course will provide a foundation for developing your technical skills related to sterility assurance.
CD/Recorded
$0
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Recorded/CD
Designing an Effective and Compliant Standard Operating Procedure (SOP) and Standard Test Method (STM)

Designing an Effective and Compliant Standard Operating Procedure (SOP) and Standard Test Method (STM)

  • Speaker: Charity Ogunsanya
  • Product ID: 705018
  • Duration: 90 Min
This webinar training will benefit manufacturers of manufactured products to achieve an effective, robust and compliant SOP and STM which will result in a cost effective and efficient manufacturing and testing of products. A well planned and written SOP or STM will reduce the incidence of out-of-specification (OOS) results, failure, product non-conformances, deviation and invalid assay investigations.
CD/Recorded
$0
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Recorded/CD
Compliance with the New EU Clinical Trial Regulation

Compliance with the New EU Clinical Trial Regulation

  • Speaker: Laura Brown
  • Product ID: 705007
  • Duration: 60 Min
This webinar will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU.
CD/Recorded
$0
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Recorded/CD
Project Risk Management

Project Risk Management

  • Speaker: Mario Mosse
  • Product ID: 705015
  • Duration: 90 Min
Project risk management includes the processes of conducting risk management planning, identification, analysis, action planning, and controlling risk on a project. This training program will analyze the objectives of project risk management - to increase the likelihood and impact of positive outcomes while decreasing the likelihood and impact of negative events affecting the success of the project.
CD/Recorded
$229
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Recorded/CD
Metrics and Dashboards for Quality and Compliance

Metrics and Dashboards for Quality and Compliance

  • Speaker: Susanne Manz
  • Product ID: 703928
  • Duration: 90 Min
This training program will discuss the challenges faced by medical device companies amid close scrutiny by industry regulators. It will also offer best practices for combating lack of transparency in quality/compliance data.
CD/Recorded
$50
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Recorded/CD
Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?

Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?

  • Speaker: Henry Urbach
  • Product ID: 703058
  • Duration: 90 Min
This webinar on biopharmaceutical raw material testing will discuss how to implement processes for the control of microbial contamination, establish microbial limits and mitigate the risk of contamination.
CD/Recorded
$199
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Recorded/CD
Navigating the variations in state food regulatory structure

Navigating the variations in state food regulatory structure

  • Speaker: Darin Detwiler
  • Product ID: 705006
  • Duration: 90 Min
This course is designed to bring food industry leaders up to speed with the latest research in states’ food regulatory characteristics. The goal is to enable industry leaders to better understand and navigate through the state-by-state nuances.
CD/Recorded
$0
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Recorded/CD
Project Management Essentials: The 8 Keys to Successfully Completing Every Project On-Time and On Budget

Project Management Essentials: The 8 Keys to Successfully Completing Every Project On-Time and On Budget

  • Speaker: Christopher R DeVany
  • Product ID: 705013
  • Duration: 90 Min
This training program will help attendees grasp the essentials of project management and plan effectively for identifying project needs. It will also discuss practices for keeping content, process, and structure on track to produce positive outcomes.
CD/Recorded
$0
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