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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
ICH Stability Requirements and Challenges

ICH Stability Requirements and Challenges

  • Speaker: Wayland Rushing
  • Product ID: 704585
  • Duration: 60 Min
This training program will detail the requirements for ICH stability studies, discuss how to design stability programs for your drug product, and list analytical methods requirements. It will also focus on how to interpret the data generated by the stability programs.
CD/Recorded
$279
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Recorded/CD
Medical Device Tracking Requirements

Medical Device Tracking Requirements

  • Speaker: Vanessa Lopez
  • Product ID: 705192
  • Duration: 60 Min
Medical Device Tracking is a very important aspect of the distribution chain of a medical device. This is because it is critical to have a mechanism by which a medical device can be traced and located in its place after it leaves the manufacturer. This system of tracking helps to identify a defective device and ensure that corrective measures are taken immediately.
CD/Recorded
$169
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Recorded/CD
Preparing Compliant eCTD Submissions: Are You Prepared for Upcoming FDA Mandate on e-Submissions?

Preparing Compliant eCTD Submissions: Are You Prepared for Upcoming FDA Mandate on e-Submissions?

  • Speaker: Peggy Berry
  • Product ID: 705349
  • Duration: 60 Min
This webinar will review the CTD format requirements including documentation and technical requirements for an eCTD submissions. It will help attendees prepare for implementing the FDA upcoming mandates on e-submissions.
CD/Recorded
$10
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Recorded/CD
Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience

Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience

  • Speaker: John R Godshalk
  • Product ID: 704806
  • Duration: 60 Min
This webinar, by an ex-FDA, will cover Good Data Integrity Practice for GxP environments. Participants will understand what FDA looks for with regard to data integrity, what may need to be audited, the new guidance and application of data integrity, and relevant regulations for data integrity
CD/Recorded
$249
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Recorded/CD
Setting Specifications for Drug Substances and Drug Products

Setting Specifications for Drug Substances and Drug Products

  • Speaker: Peggy Berry
  • Product ID: 704859
  • Duration: 90 Min
This 90-minute training will discuss the requirements of ICH for using testing and stability data to set specifications for drug substances and drug products including use of special stability studies. Attendees will also learn the requirements for changing specifications through the lifecycle of the product.
CD/Recorded
$249
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Recorded/CD
How to undergo an FDA Inspection Successfully

How to undergo an FDA Inspection Successfully

  • Speaker: Marie Morin
  • Product ID: 705170
  • Duration: 90 Min
This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.
CD/Recorded
$249
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Recorded/CD
How to Prepare for the New EU Medical Device Regulations

How to Prepare for the New EU Medical Device Regulations

  • Speaker: Richard Young
  • Product ID: 705513
  • Duration: 90 Min
The course is designed to review critical elements of the new regulations and will be run as an interactive 2 hour course designed for business leaders with a good working knowledge of current requirements.
CD/Recorded
$279
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Recorded/CD
Navigating the Regulatory Landscapes from State to State

Navigating the Regulatory Landscapes from State to State

  • Speaker: Darin Detwiler
  • Product ID: 705417
  • Duration: 60 Min
This webinar will provide participants with competitive insight into differences between states’ regulatory agencies, impact(s) of states’ funding sources on their food regulatory authority and variations in states’ history of adopting federal food policies such as FDA Food Code.
CD/Recorded
$199
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Recorded/CD
Building a Vendor Qualification Program for FDA Regulated Industries

Building a Vendor Qualification Program for FDA Regulated Industries

  • Speaker: Jonathan M Lewis
  • Product ID: 703467
  • Duration: 60 Min
This webinar will teach attendees best practices for building a sustainable vendor qualification program for FDA regulated industries. It will discuss common pitfalls to avoid when qualifying vendors.
CD/Recorded
$249
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Recorded/CD
Change Control Best Practices: Avoiding Unintended Consequences of Changes

Change Control Best Practices: Avoiding Unintended Consequences of Changes

  • Speaker: Andrew Campbell
  • Product ID: 703540
  • Duration: 90 Min
This webinar will provide an overview of regulatory requirements for change control. It will focus on changes to equipment, facilities, materials/components, test methods, suppliers, specifications, etc.
CD/Recorded
$169
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Recorded/CD
Laboratory Accreditation: Getting there is Just the Beginning

Laboratory Accreditation: Getting there is Just the Beginning

  • Speaker: Michael Brodsky
  • Product ID: 703285
  • Duration: 60 Min
This training on laboratory accreditation will focus on ISO/IEC 17025 requirements. Attendees will learn how to develop and maintain a quality management system to ensure compliance with the international laboratory accreditation standard.
CD/Recorded
$199
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Recorded/CD
Remediating Water System Biofilm - What to Do After It Gets Ahead of You

Remediating Water System Biofilm - What to Do After It Gets Ahead of You

  • Speaker: T.C Soli
  • Product ID: 702860
  • Duration: 90 Min
This pharmaceutical water systems webinar training will discuss what you should do when your monitoring data tells you that you may have a significant biofilm problem. It covers how to verify that the data and your interpretation of the data are correct, as well as the location of the problem which gives you clues as to what caused the problem and its impact on manufacturing and product.
CD/Recorded
$249
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Recorded/CD
FSSC 22000 Food Safety System Certification

FSSC 22000 Food Safety System Certification

  • Speaker: Farhad Mehrabi Nejad
  • Product ID: 705479
  • Duration: 90 Min
To be certified with FSSC 22000; a food manufacturing needs to implement processes that address all the Requirements of FSSC 22000. This Webinar lumps together the Processes including Resources and Trainings needed to implement FSSC 22000.
CD/Recorded
$199
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Recorded/CD
How to Analyze PQ Data with Multiple Populations/ Failure Modes using Minitab®

How to Analyze PQ Data with Multiple Populations/ Failure Modes using Minitab®

  • Speaker: Jerry Phillips
  • Product ID: 705281
  • Duration: 90 Min
This training will provide an understanding of graphical tools used to identify multiple populations or failure modes. Attendees will learn how to estimate product reliability for multiple populations using Minitab® v17.
CD/Recorded
$249
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Recorded/CD
Safe Drinking Water - Another Oxymoron?

Safe Drinking Water - Another Oxymoron?

  • Speaker: Michael Brodsky
  • Product ID: 703944
  • Duration: 60 Min
This training program will discuss the sources and causes of waterborne disease and what microbial options are available to assess and minimize the risk.
CD/Recorded
$249
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Recorded/CD
Leadership in Manufacturing Contamination Control: The Microbiology Lab

Leadership in Manufacturing Contamination Control: The Microbiology Lab

  • Speaker: T.C Soli
  • Product ID: 701478
  • Duration: 60 Min
This webinar on Contamination Control will discuss, how the micro lab can be more effectively utilized to prevent or head off microbial contamination issues as well as effectively resolve problems like recurring micro failures, investigations, and ineffective CAPAs.
CD/Recorded
$179
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Recorded/CD
Post-market Surveillance - Clinical Evaluation and Risk Management

Post-market Surveillance - Clinical Evaluation and Risk Management

  • Speaker: Daniel O Leary
  • Product ID: 705402
  • Duration: 90 Min
This Post-market Surveillance (PMS) webinar will discuss in detail the clinical evaluation and risk management requirements as described in MedDev 2.7/1 Rev. 4, EN ISO 14971:2012 and EN ISO 14971:2012 standards and how they are related. It will also explain some of the recent changes in EU medical device regulations.
CD/Recorded
$249
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Recorded/CD
FSMA Foreign Supplier Verification

FSMA Foreign Supplier Verification

  • Speaker: Bryan Armentrout
  • Product ID: 704952
  • Duration: 60 Min
This webinar will teach you what is expected under the new requirements of the Food Safety Modernization Act. Every food company that manufactures or supplies food under FDA jurisdiction is now or will be required to have a Foreign Supplier Verification Program in place.
CD/Recorded
$179
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Recorded/CD
Validation of Complex Cell-Based Potency Methods

Validation of Complex Cell-Based Potency Methods

  • Speaker: Gwen Wise Blackman
  • Product ID: 705172
  • Duration: 60 Min
Some cell-based methods are multifaceted. This webinar will address development and validation of complex cell-based methods. It will discuss the selection of the method and the cell line, correlating the method with the pharmaceutical activity, the need for orthogonal methods, and the timeline for method validation.
CD/Recorded
$179
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Recorded/CD
How to Interpret Probability Plots

How to Interpret Probability Plots

  • Speaker: Jerry Phillips
  • Product ID: 705161
  • Duration: 90 Min
This webinar explains what it means to be “normally distributed”, how to assess normality, how to test for normality, and how to transform non-normal data into normal data.
CD/Recorded
$249
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