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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
User / Human Factors Engineering Under IEC 62366-1, -2

User / Human Factors Engineering Under IEC 62366-1, -2

  • Speaker: John E Lincoln
  • Product ID: 705111
  • Duration: 90 Min
This webinar will focus on the Key parts of IEC 62366-1:2015 and -2:2016, Human Factors Engineering and Role in Design Control (21 CFR 820.30)l, Design and Development Planning (ISO 13485 7.3) .
CD/Recorded
$299
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Recorded/CD
Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)

Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)

  • Speaker: Barry A Friedman
  • Product ID: 705433
  • Duration: 90 Min
The webinar will review the current testing requirements as defined in the new, revised FDA guidance on Endotoxin and Pyrogen testing. It will further help attendees understand the issues surrounding the Low Endotoxin Recovery (LER) and its regulatory outcome.
CD/Recorded
$299
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Recorded/CD
Hypothesis Testing, P-values and Inference: When Thinking like a Statistician Makes Sense

Hypothesis Testing, P-values and Inference: When Thinking like a Statistician Makes Sense

  • Speaker: Elaine Eisenbeisz
  • Product ID: 703552
  • Duration: 90 Min
This clinical research webinar will explore the reasoning that formulates null hypotheses and turns researchers’ hair gray. Attendees will learn the why and how of the scientific method and how to view the world with a statistician’s eyes. Also attendees will learn the possibilities and limitations of research questions and hypothesis development, how to interpret statistical findings with p-values, effect sizes, and confidence intervals.
CD/Recorded
$349
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Recorded/CD
Performing Effective Management Review of the Quality System

Performing Effective Management Review of the Quality System

  • Speaker: David L Chesney
  • Product ID: 704933
  • Duration: 90 Min
This webinar will teach you how to conduct an effective management review of the quality system which helps you understand how to plan and focus on right metrics and governed by an efficient process. Participants will also understand FDA policy regarding disclosure of management review information during inspections.
CD/Recorded
$249
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Recorded/CD
An Advanced Course on Lean Documents, Lean Configuration and Document Control

An Advanced Course on Lean Documents, Lean Configuration and Document Control

  • Speaker: Jose Mora
  • Product ID: 701653
  • Duration: 90 Min
In this training, learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of lean vs. non-lean documents.
CD/Recorded
$299
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Recorded/CD
Supplier Management: Challenges and Opportunities

Supplier Management: Challenges and Opportunities

  • Speaker: Jeff Kasoff
  • Product ID: 700193
  • Duration: 60 Min
Attend this webinar to learn the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation, including “critical” suppliers and outsourced processes. The QSR and ISO requirements for supplier assessment will be defined as well. The webinar will discuss the application of a risk-based process resulting in a customized supplier management system.
CD/Recorded
$299
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Recorded/CD
Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

  • Speaker: Ginette M Collazo
  • Product ID: 704210
  • Duration: 60 Min
This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.
CD/Recorded
$299
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Recorded/CD
How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

  • Speaker: Charity Ogunsanya
  • Product ID: 703875
  • Duration: 90 Min
This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.
CD/Recorded
$299
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Recorded/CD
Process Analytical Technology (PAT): The Impact on Pharmaceuticals Manufacturing and Validation Needs/Requirements

Process Analytical Technology (PAT): The Impact on Pharmaceuticals Manufacturing and Validation Needs/Requirements

  • Speaker: Michael Levin
  • Product ID: 701147
  • Duration: 60 Min
This webinar will provide an insight into the practical aspects of the Process Analytical Technology (PAT) and will be an invaluable source of information on various technologies and approaches that fit the PAT definitions. You will learn about regulatory initiatives to improve the quality of pharmaceutical manufacturing using PAT and validation thereof. No special technical background is required.
CD/Recorded
$99
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Recorded/CD
How to Implement the FDA SUPAC Guidance

How to Implement the FDA SUPAC Guidance

  • Speaker: Michael Levin
  • Product ID: 704312
  • Duration: 60 Min
This webinar training will cover various topics on Scale-Up and Post-Approval Changes (SUPAC). Participants will learn how to properly scale-up or scale-down pharmaceutical batch process and learn the standard set of documentation to successfully support post-approval changes.
CD/Recorded
$299
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Recorded/CD
CGMP controlled Raw Materials

CGMP controlled Raw Materials

  • Speaker: Charity Ogunsanya
  • Product ID: 705148
  • Duration: 90 Min
This webinar will help the attendee gain an understanding of the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of drug product. The scope of this webinar applies to all cGMP controlled raw materials that are received, requiring testing, release and issuance of specifications. It also applies to the processing of changes and retiring of previously issued controlled raw materials specification within the product manufacturing process. cGMP Raw materials that are used for product manufacturing has to be released for use in the production process. Guidance will be given as to the steps that every drug product manufacturer should follow in order to process all incoming cGMP controlled raw materials which includes the release for use in the manufacturing of products.
CD/Recorded
$229
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Recorded/CD
FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

  • Speaker: Danielle DeLucy
  • Product ID: 704659
  • Duration: 60 Min
The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.
CD/Recorded
$299
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Recorded/CD
How to Conduct Successful Supplier Audits

How to Conduct Successful Supplier Audits

  • Speaker: Danielle DeLucy
  • Product ID: 704499
  • Duration: 60 Min
This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations.
CD/Recorded
$249
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Recorded/CD
How to write SOP's that Avoid Human Error

How to write SOP's that Avoid Human Error

  • Speaker: Ginette M Collazo
  • Product ID: 704418
  • Duration: 90 Min
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
CD/Recorded
$219
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Recorded/CD
Root Cause Analysis - The Heart of Corrective Action

Root Cause Analysis - The Heart of Corrective Action

  • Speaker: Betty Lane
  • Product ID: 703391
  • Duration: 75 Min
This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.
CD/Recorded
$299
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Recorded/CD
Measurement Uncertainty in Microbiology

Measurement Uncertainty in Microbiology

  • Speaker: Michael Brodsky
  • Product ID: 703902
  • Duration: 60 Min
This training program will discuss the concept and application of uncertainty of measurement (MU) as required by ISO/IEC Standard 17025:2005 for laboratory accreditation, from a practical microbiological perspective, using unambiguous language and useful examples.
CD/Recorded
$249
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Recorded/CD
Human Error Investigations, Root Cause Determination and CAPA Effectiveness

Human Error Investigations, Root Cause Determination and CAPA Effectiveness

  • Speaker: Ginette M Collazo
  • Product ID: 704314
  • Duration: 90 Min
This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.
CD/Recorded
$299
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Recorded/CD
Handling OOS Test Results and Completing Robust Investigations

Handling OOS Test Results and Completing Robust Investigations

  • Speaker: Danielle DeLucy
  • Product ID: 704351
  • Duration: 90 Min
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
CD/Recorded
$299
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Recorded/CD
Best Practices for an Effective Cleaning Validation Program

Best Practices for an Effective Cleaning Validation Program

  • Speaker: Joy McElroy
  • Product ID: 704329
  • Duration: 60 Min
This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful.
CD/Recorded
$299
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Recorded/CD
Process Validation - Overview of Why and How

Process Validation - Overview of Why and How

  • Speaker: Betty Lane
  • Product ID: 703520
  • Duration: 60 Min
This webinar will provide understanding of FDA and ISO 13485 requirements for process validation and how to implement them.
CD/Recorded
$249
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