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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
Stability and Shelf Life of Medical Devices

Stability and Shelf Life of Medical Devices

  • Speaker: Stephanie Cooke
  • Product ID: 705485
  • Duration: 90 Min
This webinar will cover all relevant regulatory requirements (CFR, FDA, ISO, ASTM and European) for establishing the stability and determining the shelf-life of medical devices. Attendees will gain a better understanding of the design control process for designing medical devices.
CD/Recorded
$0
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Recorded/CD
How to Conduct a Human Factors Validation Following ISO 62366 and the 2016 FDA Guidance

How to Conduct a Human Factors Validation Following ISO 62366 and the 2016 FDA Guidance

  • Speaker: Edwin Waldbusser
  • Product ID: 705057
  • Duration: 60 Min
This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA guidance document.
CD/Recorded
$249
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Recorded/CD
Develop a Device Master Record that can assist with Device History Record Review

Develop a Device Master Record that can assist with Device History Record Review

  • Speaker: Mary Nunnally
  • Product ID: 705328
  • Duration: 60 Min
This webinar provides a basic understanding of the records required to fulfill requirements of both US FDA 21CFR 820 and ISO 13485:2016 for establishment and maintenance of a Device Master Record. It will further discuss the responsibilities of various development team members such as R&D/engineering, operations, quality assurance, project management and executive management.
CD/Recorded
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Recorded/CD
Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance

Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance

  • Speaker: Sarah Fowler Dixon
  • Product ID: 705451
  • Duration: 60 Min
This webinar will provide an understanding of the data integrity and data lifecycle within the GxP environment. Attendees will learn best practices to comply with the current regulations and industry standards for electronic data integrity throughout the data lifecycle.
CD/Recorded
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Recorded/CD
3.5-Hr Virtual Training: Introduction to Measurement Systems Assessment

3.5-Hr Virtual Training: Introduction to Measurement Systems Assessment

  • Speaker: Steven Wachs
  • Product ID: 704839
  • Duration: 3.5 hrs
This training program will offer an introduction to measurement systems, and cover implementation of Gage R&R studies, linearity assessment, attribute measurement systems, and non-replicable systems.
CD/Recorded
$449
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Recorded/CD
Laboratory Accreditation and Quality Management Systems Part 2: Technical Concerns

Laboratory Accreditation and Quality Management Systems Part 2: Technical Concerns

  • Speaker: Michael Brodsky
  • Product ID: 705299
  • Duration: 60 Min
This laboratory accreditation training program will focus on technical components of Quality Management System (QMS) including accommodation and environmental conditions, test and calibration methods, equipment, measurement traceability, sampling and much more.
CD/Recorded
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Recorded/CD
Drug Product Performance, In Vivo: Bioavailability and Bioequivalence

Drug Product Performance, In Vivo: Bioavailability and Bioequivalence

  • Speaker: Leon Shargel
  • Product ID: 705461
  • Duration: 90 Min
This webinar will discuss the basic concepts of bioavailability and bioequivalence and their relationship to drug product performance, in vivo. It will also provide practical examples to show how bioavailability and bioequivalence studies can be applied to drug product development.
CD/Recorded
$249
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Recorded/CD
Novel Foods Regulation in the European

Novel Foods Regulation in the European

  • Speaker: Vicente Rodriguez
  • Product ID: 705495
  • Duration: 60 Min
Learn what foods or food ingredients are considered 'Novel Foods'. Learn about novel foods applications, pre-marketing authorization procedures and the assessments required to demonstrate safety.
CD/Recorded
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Recorded/CD
Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs)

Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs)

  • Speaker: Stephanie Cooke
  • Product ID: 705486
  • Duration: 90 Min
This webinar will cover ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (API). Attendees will gain a deeper understanding of the importance of GMPs for APIs, apply these principles in their current roles in order to better manage quality, make improvements, solve problems and make decisions.
CD/Recorded
$179
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Recorded/CD
Issues related to informed consent in clinical trials

Issues related to informed consent in clinical trials

  • Speaker: Sarah Fowler Dixon
  • Product ID: 705453
  • Duration: 60 Min
This webinar will discuss some common literacy trends, issues with consent documents and tips to enhance the consent process.
CD/Recorded
$0
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Recorded/CD
3.5-Hr Virtual Training: Predicting Product Life Using Reliability Analysis

3.5-Hr Virtual Training: Predicting Product Life Using Reliability Analysis

  • Speaker: Steven Wachs
  • Product ID: 704830
  • Duration: 3.5 hrs
In this training program, participants will gain awareness of the overall methodology for setting reliability targets, estimating product reliability from test data and/or field data, and determining whether or not reliability targets are achieved. Participants will also learn how to calculate sample sizes for reliability testing.
CD/Recorded
$449
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Recorded/CD
Using Records to Identify Root Causes of Non-Compliance

Using Records to Identify Root Causes of Non-Compliance

  • Speaker: John Fetzer
  • Product ID: 705345
  • Duration: 60 Min
This webinar will discuss the use of records to identify root causes of non-compliance in GLP or ISO 17025 compliant laboratory.
CD/Recorded
$0
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Recorded/CD
Qualification of the Dissolution Apparatus

Qualification of the Dissolution Apparatus

  • Speaker: Gregory Martin
  • Product ID: 705342
  • Duration: 90 Min
This webinar will focus on the USP and FDA requirements for qualification of the dissolution apparatus including guidelines for USP Performance Verification Test and FDA Advanced Mechanical Calibration. It will also provide an overview of USP General Chapters <1058> and <711>.
CD/Recorded
$0
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Recorded/CD
Legal Imperative for Regulatory Compliance

Legal Imperative for Regulatory Compliance

  • Speaker: Darin Detwiler
  • Product ID: 705418
  • Duration: 60 Min
This webinar will provide participants with competitive insight into causes and true costs of food recalls and outbreak events for the industry and trends in federal prosecution relating to food industry.
CD/Recorded
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Recorded/CD
Making the Connection between FSMA and GFSI Requirements

Making the Connection between FSMA and GFSI Requirements

  • Speaker: Miranda Peguese
  • Product ID: 705061
  • Duration: 90 Min
This webinar will explore the complex relationship between GFSI and FSMA and will outline how GFSI certification can help manufacturers reach regulatory compliance.
CD/Recorded
$229
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Recorded/CD
The Latest in CLIA Compliance for Clinical Labs

The Latest in CLIA Compliance for Clinical Labs

  • Speaker: Dennis Weissman
  • Product ID: 705374
  • Duration: 90 Min
This webinar will cover in detail the regulatory requirements of Clinical Laboratory Improvement Amendments (CLIA). It will also discuss major lab quality standards such as facility administration, general laboratory systems, personnel qualifications & responsibilities, proficiency testing and more.
CD/Recorded
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Recorded/CD
Laboratory Accreditation and Quality Management Systems Part 1: Management Concerns

Laboratory Accreditation and Quality Management Systems Part 1: Management Concerns

  • Speaker: Michael Brodsky
  • Product ID: 705298
  • Duration: 90 Min
This training program will cover the requirements of ISO/IEC 17025 laboratory accreditation standard. It will focus on management components of QMS including document control, quality system, service to customer, internal audits and much more.
CD/Recorded
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Recorded/CD
Risk Based Approach in cGMP - Quality Risk Management (QRM)

Risk Based Approach in cGMP - Quality Risk Management (QRM)

  • Speaker: Shana Dressel
  • Product ID: 705412
  • Duration: 60 Min
This webinar will cover FDA’s current thinking on QRM and Guidance for Industry - Q9 Quality Risk Management, provide information to help understanding of QRM concepts, and applications. In addition, brief review of how ICH Q8, Q9, and Q10 work in coherence throughout product lifecycle.
CD/Recorded
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Recorded/CD
FDA Inspections: What Regulations Expect

FDA Inspections: What Regulations Expect

  • Speaker: Joy McElroy
  • Product ID: 705346
  • Duration: 90 Min
Attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. It will provide an in-depth understanding of how to prepare for unannounced FDA audits and inspections.
CD/Recorded
$179
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Recorded/CD
Pharmacokinetics of Oral Absorption

Pharmacokinetics of Oral Absorption

  • Speaker: Leon Shargel
  • Product ID: 705458
  • Duration: 90 Min
This webinar will discuss pharmacokinetic principles of systemic drug absorption and its applications to the development of oral dosage forms. It will also provide practical examples to show how pharmacokinetics of oral absorption can be applied to drug product development.
CD/Recorded
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