ComplianceOnline

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.

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
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
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
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
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
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
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
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
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
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
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
Recorded/CD
Medical Device Software Verification and Validation

Medical Device Software Verification and Validation

  • Speaker: Nancy Knettell
  • Product ID: 705393
  • Duration: 60 Min
This webinar will teach you how to design, build and test medical device software in preparation for the successful 510k submissions. It will cover medical device software user requirements, software architecture, design, unit testing and more.
CD/Recorded
$169
Recorded/CD
Bioavailability and Bioequivalence Studies submitted in NDAs and INDs

Bioavailability and Bioequivalence Studies submitted in NDAs and INDs

  • Speaker: Stephanie Cooke
  • Product ID: 705506
  • Duration: 90 Min
Attendees that need to perform bioavailability (BA) and bioequivalence (BE) studies for INDs, NDAs or for NDA supplements should attend this training. They will learn the requirements of such studies, per 21 CFR 320 and all other relevant regulatory documents.
CD/Recorded
$279
Recorded/CD
How to Select and Manage Vendors in a Regulated Environment (incl. ICH E6)

How to Select and Manage Vendors in a Regulated Environment (incl. ICH E6)

  • Speaker: Angela Bazigos
  • Product ID: 705488
  • Duration: 90 Min
Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?
CD/Recorded
$0
Recorded/CD
Mobile Medical Apps (Is It a FDA Regulated Device?) and Cybersecurity

Mobile Medical Apps (Is It a FDA Regulated Device?) and Cybersecurity

  • Speaker: Edwin Waldbusser
  • Product ID: 705432
  • Duration: 60 Min
This webinar will provide an overview of mobile medical apps and discuss when the app becomes the FDA regulated medical device. It will also discuss the cybersecurity requirements for mobile apps.
CD/Recorded
$0
Recorded/CD
3.5 hr Virtual Boot Camp: How to Survive an FDA Food Facility Inspection

3.5 hr Virtual Boot Camp: How to Survive an FDA Food Facility Inspection

  • Speaker: Angela Bazigos
  • Product ID: 705520
  • Duration: 3.5 hrs
This Virtual Boot Camp will provide an overview of the FDA inspection program, how to prepare for an inspection of your facility and the FDA program that applies to foreign food facility inspections.
CD/Recorded
$0
Recorded/CD
Selection and Auditing of Analytical Contract Laboratories:  Best Practices for Pharmaceutical Scientists

Selection and Auditing of Analytical Contract Laboratories: Best Practices for Pharmaceutical Scientists

  • Speaker: Daniel Norwood
  • Product ID: 705169
  • Duration: 90 Min
This webinar on selection and auditing of analytical contract laboratories will guide the participants to understand the process of CRO selection for analytical testing. Attendees will gain knowledge on the basic principles of quality auditing of a CRO; including audit planning, scheduling, conducting an audit, and the audit report process.
CD/Recorded
$249
Recorded/CD
Stability and Shelf Life of Medical Devices

Stability and Shelf Life of Medical Devices

  • Speaker: Stephanie Cooke
  • Product ID: 705485
  • Duration: 90 Min
This webinar will cover all relevant regulatory requirements (CFR, FDA, ISO, ASTM and European) for establishing the stability and determining the shelf-life of medical devices. Attendees will gain a better understanding of the design control process for designing medical devices.
CD/Recorded
$0
Recorded/CD
How to Conduct a Human Factors Validation Following ISO 62366 and the 2016 FDA Guidance

How to Conduct a Human Factors Validation Following ISO 62366 and the 2016 FDA Guidance

  • Speaker: Edwin Waldbusser
  • Product ID: 705057
  • Duration: 60 Min
This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA guidance document.
CD/Recorded
$249
Recorded/CD
Develop a Device Master Record that can assist with Device History Record Review

Develop a Device Master Record that can assist with Device History Record Review

  • Speaker: Mary Nunnally
  • Product ID: 705328
  • Duration: 60 Min
This webinar provides a basic understanding of the records required to fulfill requirements of both US FDA 21CFR 820 and ISO 13485:2016 for establishment and maintenance of a Device Master Record. It will further discuss the responsibilities of various development team members such as R&D/engineering, operations, quality assurance, project management and executive management.
CD/Recorded
$0
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