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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
Quality Expectations for Drugs and Biologics during Early Development: Phase 2

Quality Expectations for Drugs and Biologics during Early Development: Phase 2

  • Speaker: Steven S Kuwahara
  • Product ID: 701010
  • Duration: 75 Min
This presentation will be aimed at helping Regulatory, Quality Assurance and Quality Control personnel to understand the varying levels of quality activities that accompany early stages of Product development. Emphasis will be placed on the transition into full GMP work as clinical trials proceed, but the requirements for NDAs (or BLAs) will be discussed.
CD/Recorded
$299
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Recorded/CD
The Kaizen Event and how it can help improve your Quality Program

The Kaizen Event and how it can help improve your Quality Program

  • Speaker: Brad Snyder
  • Product ID: 700977
  • Duration:
Kaizen Events are an extremely efficient way to quickly improve process efficiencies and effectiveness.
CD/Recorded
$249
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Recorded/CD
CAPA - Root cause and risk management

CAPA - Root cause and risk management

  • Speaker: Dr. Norman Howe
  • Product ID: 700997
  • Duration: 40 Min
Participants will learn how to write CA reports that will be used as written & how a well maintained CAPA system will save the company time and money. This course summarizes the cGMP requirements for Corrective Action Preventive Action (CAPA) and prepares participants to complete CAPA investigations on their own.
CD/Recorded
$149
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Recorded/CD
CAPA Management and Compliance with Regulatory Requirements

CAPA Management and Compliance with Regulatory Requirements

  • Speaker: Bernice Russell Bond
  • Product ID: 700943
  • Duration: 75 Min
This regulatory training will provide benefits to companies’ required to have a process for collecting, assessing and documenting deviation and complaints and ensuring that corrective and preventive actions are compliant with GXP requirements.
CD/Recorded
$249
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Recorded/CD
Effective CAPA Management: How to Implement a Risk-based Approach to Improve Your Quality System

Effective CAPA Management: How to Implement a Risk-based Approach to Improve Your Quality System

  • Speaker: Ken Peterson
  • Product ID: 700994
  • Duration:
In this course, we will introduce you to a new method of managing your CAPA system, The Gateway: A Risk-based Filter. This webinar is geared toward professionals in the QA/AC and CAPA discipline and is appropriate for individuals who are regularly called upon to resolve problems, or whose input would aid in preventing problems.
CD/Recorded
$249
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Recorded/CD
Introduction to Process Capability (Cp, CpK, Pp, Ppk)

Introduction to Process Capability (Cp, CpK, Pp, Ppk)

  • Speaker: Lawrence Mucha
  • Product ID: 700342
  • Duration: 60 Min
This webinar will provide valuable assistance to all regulated companies that need to validate their systems In this session we will introduce basic control charting and statistical methods to determine if a process is capable of consistently producing product within specifications and how to make it capable if it is not
CD/Recorded
$299
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Recorded/CD
Validation Requirements Based on ICH Q9

Validation Requirements Based on ICH Q9

  • Speaker: Jamie Jamshidi
  • Product ID: 700932
  • Duration: 90 Min
This program is specially designed for personnel in the Pharmaceutical and Biotechnology industries. This guidance provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.
CD/Recorded
$249
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Recorded/CD
Quality Expectations for Product Development CMC Activities: R & D, GLP or GMP

Quality Expectations for Product Development CMC Activities: R & D, GLP or GMP

  • Speaker: Steven S Kuwahara
  • Product ID: 700949
  • Duration: 75 Min
This presentation will discuss the quality-related activities that are expected for different stages of the product development process. Emphasis will be placed on the transition into full GMP work as clinical trials proceed, but the requirements for DMFs and NDAs (or BLAs) will be discussed.
CD/Recorded
$299
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Recorded/CD
Quality by Design: what the FDA wants, what you must do, how you can deliver to their expectations and what relief you can expect

Quality by Design: what the FDA wants, what you must do, how you can deliver to their expectations and what relief you can expect

  • Speaker: Peter Calcott
  • Product ID: 700893
  • Duration: 60 Min
This webinar will describe the origins and rationale for the QbD program. It will describe the successes in the generic and drug areas and the opportunities in the biologics areas. The fruits of the program can bring a higher success rate in the commercial operations with its impact on cost of goods, reduced reporting requirements or at least a reduction in the level of reporting for supplements and less complex or stressful inspections.
CD/Recorded
$249
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Recorded/CD
The CAPA Trap or Common Problems and Pitfalls

The CAPA Trap or Common Problems and Pitfalls

  • Speaker: Jeff Phillips
  • Product ID: 700914
  • Duration: 60 Min
The following webinar will cover common CAPA problems across industries and how to avoid them. This webinar will provide valuable assistance to all regulated companies that need to have CAPA systems as mandated by the FDA.
CD/Recorded
$249
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Recorded/CD
Six Sigma Methodology for Process Validation

Six Sigma Methodology for Process Validation

  • Speaker: Lawrence Mucha
  • Product ID: 700340
  • Duration: 90 Min
This webinar will provide valuable assistance to all regulated companies that need to validate their systems The series will deal with Operational Qualification (OQ), Performance Qualification (PQ), and maintaining a state of validation using statistical methods associated with Six Sigma
CD/Recorded
$149
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Recorded/CD
Overview of Quality by Design

Overview of Quality by Design

  • Speaker: John Avellanet
  • Product ID: 700862
  • Duration: 60 Min
This seminar presents the basics of Quality by Design in such a way as to allow attendees to understand Quality by Design as it applies to their company and their products. Six years after the announcement of the FDA’s cGMP Initiative for the 21st Century, the FDA has finally coalesced on an approach it calls “Quality by Design.” Despite numerous presentations by FDA officials, several pilot programs and the adoption of Quality by Design by the International Conference on Harmonization (ICH), confusion about Quality by Design reigns throughout the pharmaceutical, biotechnology and medical device industries.
CD/Recorded
$149
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Recorded/CD
Quality System Training Requirements

Quality System Training Requirements

  • Speaker: Ronald Schoengold
  • Product ID: 700781
  • Duration: 60 Min
The workshop will provide guidance on the roles and responsibilities of each functional area in the company and how they relate to each other. Each company must demonstrate full implementation of the quality system by providing appropriate training and re-training when necessary, for its employees.
CD/Recorded
$249
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Recorded/CD
Introduction to Statistical Process Control (SPC)

Introduction to Statistical Process Control (SPC)

  • Speaker: Lawrence Mucha
  • Product ID: 700343
  • Duration: 60 Min
This session will introduce advanced control charting for multiple stream processes. We will also introduce control chart analysis and how to select the correct control chart and interpretation and reaction to control chart signals.
CD/Recorded
$249
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Recorded/CD
Applying Lean Documents to a Project - how to create a project file, follow design controls, yet maintain a lean set of project documents

Applying Lean Documents to a Project - how to create a project file, follow design controls, yet maintain a lean set of project documents

  • Speaker: Jose Mora
  • Product ID: 700358
  • Duration: 60 Min
Using the lean document approach, documents are written by the authors with the highest level of expertise, and information is presented in a simple, organized way This webinar explains the use of lean document principles and presents a step-by-step approach to creating a Design History File, a Device Master Record, and other key supporting documents
CD/Recorded
$149
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Recorded/CD
The FDA's Outlook for Quality in Device Manufacturing

The FDA's Outlook for Quality in Device Manufacturing

  • Speaker: James Harris(PhD)
  • Product ID: 700645
  • Duration: 60 Min
This Device Manufacturing webinar provide a understanding of the GMP and Quality requirements for the design, manufacture, storage, distribution, and installation of Medical Devices including the requirements for complaint handling, and servicing.
CD/Recorded
$249
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Recorded/CD
Introduction to statistical Design and Analysis of Experiments (DOE)

Introduction to statistical Design and Analysis of Experiments (DOE)

  • Speaker: Lawrence Mucha
  • Product ID: 700344
  • Duration: 60 Min
This statistical Design and Analysis of Experiments webinar will introduce DOE and process modeling.
CD/Recorded
$249
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Recorded/CD
Designing in Quality via Statistical Process Control

Designing in Quality via Statistical Process Control

  • Speaker: Vinny Sastri
  • Product ID: 700411
  • Duration: 60 Min
This statistical process control training will provide an overview of statistical process control (SPC) describe various types of control charts and how they can be used for trend analysis, defect reduction, product capability assessment. Quality, safety and efficacy must be designed into a product. Quality cannot be inspected or tested in the finished product.
CD/Recorded
$249
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Recorded/CD
Management Controls needed for an effective QMS to meet FDA QSR and ISO 13485 regulations

Management Controls needed for an effective QMS to meet FDA QSR and ISO 13485 regulations

  • Speaker: Susan C Reilly
  • Product ID: 700134
  • Duration: 60 Min
This Management control training will provide the principles and practices needed to effectively develop and implement the Management Controls to ensure an effective Quality Management System and to comply with the FDA QS Regulation.
CD/Recorded
$299
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Recorded/CD
Quantitative Approach to User Requirements Risk Assessment

Quantitative Approach to User Requirements Risk Assessment

  • Speaker: Vimarie Ortiz
  • Product ID: 700390
  • Duration: 60 Min
This Risk management training offers a quantitative risk management approach you can use to measure system implementation and enhancement efforts against the criticality and business/regulatory significance of the system.
CD/Recorded
$249
View Details
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