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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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Powerful Closed-loop CAPA - Meeting FDA Expectations
28
/ Sep
Wednesday-2022

Powerful Closed-loop CAPA - Meeting FDA Expectations

  • Speaker: John E Lincoln
  • Product ID: 702012
  • Duration: 90 Min
This 90-minute webinar will show how you can implement a closed-loop CAPA system that meets CGMP requirements and U.S. FDA expectations. You will learn simple, but powerful, tools and methods that you can use regularly and systematically to define and resolve root causes, not just symptoms.
* Per Attendee
$249
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Recorded/CD
Effective Systems for Change Control in the Pharmaceutical Industry

Effective Systems for Change Control in the Pharmaceutical Industry

  • Speaker: David L Chesney
  • Product ID: 705002
  • Duration: 90 Min
This webinar will help you understand GMP requirements for change control from a pharmaceutical manufacturing perspective, the purpose of change control and what types of changes are or are not subject to change control. Participants will learn how to execute and implement a change in a regulated environment.
CD/Recorded
$249
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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
How to Use Quality Systems Inspection Technique (QSIT) to Your Advantage

How to Use Quality Systems Inspection Technique (QSIT) to Your Advantage

  • Speaker: Jeff Kasoff
  • Product ID: 700788
  • Duration: 60 Min
This Webinar provides valuable assistance to all individuals who liaison with the FDA during inspections. It will also benefit senior management, who need to understand the methodologies used by FDA during inspections. During FDA inspections, several individuals from the organization work closely with FDA officials. For them and for senior management, understanding the intricacies of the methodologies used by the FDA is clearly of high importance.
CD/Recorded
$299
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Recorded/CD
How to Prepare a Standard Operating Procedure (SOP)?

How to Prepare a Standard Operating Procedure (SOP)?

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705131
  • Duration: 60 Min
This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
CD/Recorded
$299
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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
Good Documentation Guideline (Chapter <1029> USP)

Good Documentation Guideline (Chapter <1029> USP)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705130
  • Duration: 60 Min
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
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
Annual Current Good Manufacturing Practices (cGMP) Training

Annual Current Good Manufacturing Practices (cGMP) Training

  • Speaker: Kelly Thomas
  • Product ID: 705422
  • Duration: 60 Min
This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.
CD/Recorded
$249
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Recorded/CD
Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705583
  • Duration: 60 Min
In this webinar, we will discuss the definition, purpose, importance of GDP, General rules of GDP, GDP as it applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029>, and introduction “Good Documentation Guidelines”. We will also briefly introduce you to the European Union (EU) GDP, and its enforcement along with some observation samples from FDA.
CD/Recorded
$299
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Recorded/CD
CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

  • Speaker: Roger Cowan
  • Product ID: 703476
  • Duration: 60 Min
This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.
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
Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

  • Speaker: Roger Cowan
  • Product ID: 703727
  • Duration: 60 Min
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.
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
$299
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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
$399
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