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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
3-Hour Virtual Training: Lean Leadership, Quality and the Customer

3-Hour Virtual Training: Lean Leadership, Quality and the Customer

  • Speaker: Charles H Paul
  • Product ID: 705109
  • Duration: 180 Min
Lean is not a quick fix for doing more with less and doing it in half the time – it is not something you undertake to realize short-term improvements – it is on the other hand, a new way of thinking about your business and a new way of executing business activities. This virtual training and the others in the series will lead you through the journey of lean from its inception through complete implementation.
CD/Recorded
$449
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Recorded/CD
Contamination Control in Pharmaceutical, Biotech and Medical Device Cleanroom

Contamination Control in Pharmaceutical, Biotech and Medical Device Cleanroom

  • Speaker: Jim Polarine
  • Product ID: 705078
  • Duration: 90 Min
This 90-minute webinar will cover general considerations for microbial control for non-sterile manufacturing areas, including attributes of an effective cleaning and disinfection program. Points to consider specifically aimed at oral solid dose (OSD) manufacturers will also be presented, including cleaning and disinfection of both product contact and non-product contact surfaces.
CD/Recorded
$0
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Recorded/CD
Pasteurization Instruments and Records in a Food Processing Facility

Pasteurization Instruments and Records in a Food Processing Facility

  • Speaker: Thomas Perkins
  • Product ID: 704914
  • Duration: 60 Min
The webinar will address the various records required by government agencies in the commercial conversion and packaging of food production. This webinar is designed to allow field level management to competently represent the local process and records as they are intended to satisfy the regulation.
CD/Recorded
$199
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Recorded/CD
Linear Regression Analysis for Medical Device Manufacturing

Linear Regression Analysis for Medical Device Manufacturing

  • Speaker: Daniel O Leary
  • Product ID: 705108
  • Duration: 90 Min
Analyzing processes to understand their operation and implementing improvement is a necessary element in any quality system, but is especially important in medical devices. One of the more important tools is linear regression. Using Excel, you can get the information you need for process improvement.
CD/Recorded
$0
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Recorded/CD
Use of SPC in the Biopharmaceutical industry: use and implementation

Use of SPC in the Biopharmaceutical industry: use and implementation

  • Speaker: Jeffrey Staecker
  • Product ID: 705074
  • Duration: 60 Min
The webinar will describe application of SPC in manufacturing and QC and how to integrate SPC into the Quality System.
CD/Recorded
$0
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Recorded/CD
Introduction to FDA and EU Medical Device Submission

Introduction to FDA and EU Medical Device Submission

  • Speaker: Charles H Paul
  • Product ID: 705065
  • Duration: 60 Min
This webinar will overview each critical aspect of the FDA submissions process to include 510(k) and PMA) and contrast those key steps to those of the EU Medical Device Directives Submissions process.
CD/Recorded
$0
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Recorded/CD
Quality Control for Microbiological Media and Reagents

Quality Control for Microbiological Media and Reagents

  • Speaker: Todd Graham
  • Product ID: 705060
  • Duration: 60 Min
This webinar will give you the tools you need to maintain a quality supply of media and reagents in a variety of microbiology laboratories. A thorough understanding of the variety of challenges necessary in maintain quality media and reagents will be brought to the fore. This will allow you to perform microbiology testing with confidence.
CD/Recorded
$169
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Recorded/CD
Performing an Effective Out-of-Specification Result Investigation

Performing an Effective Out-of-Specification Result Investigation

  • Speaker: Charity Ogunsanya
  • Product ID: 705064
  • Duration: 90 Min
This webinar will provide the basic understanding of how to conduct a compliant and effective out-of-specification (OOS) result investigation which is critical in preventing product recalls, voluntary and involuntary plant shut down, and FDA 483 findings or warning letter. It will also provide a basic mainframe for the Quality Assurance unit in the final disposition of the affected finished product as well as provide guidance for the different types of OOS investigational systems.
CD/Recorded
$0
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Recorded/CD
Subcontractor auditing (cGMP/Pharma/Med device industries)

Subcontractor auditing (cGMP/Pharma/Med device industries)

  • Speaker: Jan Warner
  • Product ID: 705063
  • Duration: 90 Min
This course will describe the basic principles and requirements for building a supplier audit program. This webinar will provide a framework on which to build your subcontractor auditing program.
CD/Recorded
$0
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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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