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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
Discussion of Revisions Contained in ISO 13485:2016

Discussion of Revisions Contained in ISO 13485:2016

  • Speaker: Edward Kimmelman
  • Product ID: 704506
  • Duration: 90 Min
The training program will prepare attendees to better understand the revisions to this standard as they read its requirements in detail. For those organizations that have a QMS that's compliant with ISO 13485:2003, you will benefit from this program as it will help you assess your preparations.
CD/Recorded
$229
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Recorded/CD
4-Hour Virtual Training: FDA Regulations for Marketing and Labeling OTC Drugs in the U.S.

4-Hour Virtual Training: FDA Regulations for Marketing and Labeling OTC Drugs in the U.S.

  • Speaker: Norma Skolnik
  • Product ID: 704530
  • Duration: 4 hrs
The objective of this virtual training seminar is to assist attendees in understanding and being able to apply FDA regulations for OTC drugs and to label and market them successfully in the U.S. while avoiding regulatory problems. The program will also explore other verticals such as: OTC drug monographs and their importance to product marketing, a summary of OTC drug GMP regulations, FDA rules for adverse event reporting of OTC drugs, avoiding FDA Warning Letters, and more.
CD/Recorded
$0
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Recorded/CD
Emerging Issues in Food Safety - Locally, Nationally and Globally

Emerging Issues in Food Safety - Locally, Nationally and Globally

  • Speaker: Michael Brodsky
  • Product ID: 704518
  • Duration: 60 Min
This training program will focus on understanding and accepting our respective responsibilities to help ensure that our food supply is safe by pursuing a food safety culture locally, nationally and globally.
CD/Recorded
$0
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Recorded/CD
3D Printing for Manufacturing Regulated Products: FDA's Current Acceptance and Future Projections

3D Printing for Manufacturing Regulated Products: FDA's Current Acceptance and Future Projections

  • Speaker: Mukesh Kumar
  • Product ID: 703621
  • Duration: 60 Min
The webinar will discuss the current available regulatory pathways to develop FDA-regulated 3D printed products and also predictions on what to expect in the near future. 3D printing in personalized treatments will be discussed and attendees will be provided practical tips for pursuing approval with the FDA.
CD/Recorded
$229
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Recorded/CD
3-Hour Virtual Training: Russia Regulatory Compliance Requirements for Life Science Products

3-Hour Virtual Training: Russia Regulatory Compliance Requirements for Life Science Products

  • Speaker: Robert J Russell
  • Product ID: 704356
  • Duration: 3 hrs
This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.
CD/Recorded
$429
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Recorded/CD
Educating and Training Staff to Manage Regulatory Records

Educating and Training Staff to Manage Regulatory Records

  • Speaker: Charlie Sodano
  • Product ID: 704493
  • Duration: 60 Min
This training program will explore why planning and implementing an information management solution can be a daunting task. Composing policies and procedures is a good start, followed by testing in small groups. But a lot of people are resistant to changing their work practices, especially if they have been working for an organization for a long time. The worst thing that can happen is that staff appears to be compliant with the new plan, but has found a way to continue their prior practices under the radar. The solution to this problem is a comprehensive initial and continuing educational plan.
CD/Recorded
$229
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Recorded/CD
Performance Metrics

Performance Metrics

  • Speaker: Susan Muhr Leister
  • Product ID: 704184
  • Duration: 60 Min
This training program will discuss how to effectively create performance metrics and goals for your department or project. It will also discuss the key components of a metric and when to use different types of performance metrics.
CD/Recorded
$50
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Recorded/CD
Design Inputs Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration

Design Inputs Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration

  • Speaker: Jose Mora
  • Product ID: 703321
  • Duration: 60 Min
This webinar will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to these linked and cascading documents.
CD/Recorded
$179
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Recorded/CD
Microbiological Risk: Do I Really Need to Test Raw Materials for Microorganisms

Microbiological Risk: Do I Really Need to Test Raw Materials for Microorganisms

  • Speaker: Henry Urbach
  • Product ID: 702635
  • Duration: 60 Min
This webinar will cover the regulatory perspective in testing raw materials for microorganisms and how you can manage the risk of raw materials being the major source of microbial contamination in your medical product manufacturing process.
CD/Recorded
$229
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Recorded/CD
FDA Inspection Preparedness

FDA Inspection Preparedness

  • Speaker: Susan Muhr Leister
  • Product ID: 704221
  • Duration: 60 Min
This training program will discuss key terms and responsibilities related to FDA inspections and the purpose of the BIMO inspection program. It will also review the general purpose and overall process of an FDA inspection and enhance your inspection preparation strategies.
CD/Recorded
$229
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Recorded/CD
FDA’s New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices

FDA’s New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices

  • Speaker: Angela Dunston
  • Product ID: 704431
  • Duration: 90 Min
This training program will provide a review of the current testing requirements and discuss what happened to the old 87/91 LAL Guidance for Industry proposed guidance. The program will also discuss how to transition from one bacterial endotoxin test to another—understanding the RPT (Rabbit Pyrogen Test). Participants will also gain a clearer perspective of the Monocyte Activation Test (MAT).
CD/Recorded
$229
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Recorded/CD
Creating Proper User Requirement Specifications (URS) for Computer Systems Validation (CSV) - Ensuring Overall Regulatory Compliance

Creating Proper User Requirement Specifications (URS) for Computer Systems Validation (CSV) - Ensuring Overall Regulatory Compliance

  • Speaker: Gaurav Walia
  • Product ID: 704370
  • Duration: 75 Min
This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.
CD/Recorded
$229
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Recorded/CD
Process Robustness: The New FDA Paradigm

Process Robustness: The New FDA Paradigm

  • Speaker: Angela Dunston
  • Product ID: 703990
  • Duration: 90 Min
In this training program, attendees will learn how process robustness tools and metrics can be utilized to enhance process understanding and control. The new FDA paradigm is shifting to the expectation that organizations certified by other standards such as ISO and EFfCI demonstrate process robustness. It is the obligation of the primary pharmaceutical provider to ensure process robustness throughout the supply chain.
CD/Recorded
$229
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Recorded/CD
Using Analysis of Variance - A Practical Approach

Using Analysis of Variance - A Practical Approach

  • Speaker: Daniel O Leary
  • Product ID: 703824
  • Duration: 60 Min
This training program will illustrate the underlying idea that makes ANOVA work. It will also offer an understanding of the data collection issues you should plan and how to get access to ANOVA in Excel.
CD/Recorded
$229
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Recorded/CD
How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment

How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment

  • Speaker: Michael Levin
  • Product ID: 704274
  • Duration: 60 Min
Among other key topics, this training program will focus on what can be monitored in mixing operations, wet granulation operations, dry granulation operations, compaction operations, and coating operations.
CD/Recorded
$229
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Recorded/CD
Preparing for FDA's Unique Device Identification Rule

Preparing for FDA's Unique Device Identification Rule

  • Speaker: Daniel O Leary
  • Product ID: 702594
  • Duration: 90 Min
This 90-minute webinar will review FDA's draft regulations for UDI and describe the new requirements for labeling medical devices. It covers the new regulations in 21 CFR Part 830, the changes to Part 820, the Quality System Regulation; Part 801, Labeling; Part 803, Medical Device Reporting; Part 806 Corrections and Removals; and other regulations.
CD/Recorded
$229
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Recorded/CD
Making Sense of BSCs, Hoods, Isolators, RABs

Making Sense of BSCs, Hoods, Isolators, RABs

  • Speaker: Joseph Winslow
  • Product ID: 704361
  • Duration: 60 Min
Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.
CD/Recorded
$229
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Recorded/CD
Pharmaceutical Water Use and Monitoring

Pharmaceutical Water Use and Monitoring

  • Speaker: Igor Gorsky
  • Product ID: 704336
  • Duration: 150 Min
This training program will guide attendees on how to best deliver water from a high purity water distribution system. Attendees will learn to capitalize on the advantages of online analytical instrumentation and understand the value of rapid microbiological methods. The program will also offer an understanding of real-time release of water.
CD/Recorded
$50
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Recorded/CD
Upcoming Changes to ISO 14-644 Parts 1 and 2 - Cleanrooms and Associated Controlled Environments

Upcoming Changes to ISO 14-644 Parts 1 and 2 - Cleanrooms and Associated Controlled Environments

  • Speaker: Joseph Winslow
  • Product ID: 704339
  • Duration: 60 Min
Attendees will come away from this training program with a good understanding of upcoming changes to the ISO standard and the implication of those changes to the classification and operation of clean rooms in regulated industries.
CD/Recorded
$229
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Recorded/CD
How to Survive FDA's New Inspection and Enforcement Practices

How to Survive FDA's New Inspection and Enforcement Practices

  • Speaker: Dr. Ludwig Huber
  • Product ID: 704328
  • Duration: 75 Min
This training program will enumerate the inspection process for API, drug and device manufacturers and summarize recent changes. It will guide attendees on preparing staff for the new FDA inspections and discuss the role of exit meeting to avoid enforcement.
CD/Recorded
$229
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