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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
How to Design an Effective and Efficient ISO 9001:2000 Management Review Process

How to Design an Effective and Efficient ISO 9001:2000 Management Review Process

  • Speaker: Michael A Mathe
  • Product ID: 700138
  • Duration: 60 Min
This webinar will focus on integrating PDCA with management review’s general, input and output clause requirements leading towards the design of both an effective and efficient management review process. Management review is truly one of ISO’s key processes. It is the gateway to understanding and managing all of the inputs and outputs of an effective quality management system.
CD/Recorded
$249
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Recorded/CD
ISO 9001:2000 1st, 2nd and 3rd Party Auditing & Implementation

ISO 9001:2000 1st, 2nd and 3rd Party Auditing & Implementation

  • Speaker: Mark Stevens
  • Product ID: 700060
  • Duration: 60 Min
In this ISO 9001:2000 Training Understand the ISO 9001:2000 standard requirements for 1st, 2nd and 3rd part audits.
CD/Recorded
$249
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Recorded/CD
Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

  • Speaker: Kenneth Christie
  • Product ID: 703635
  • Duration:
This training program will provide attendees with a better understanding of how the FDA conducts their audits and the areas of most focus. In addition, it provides a summary of common GMP deficiencies given to drug manufacturers, to use to evaluate one’s own practices. Finally, when given a regulatory audit finding, this webinar will review the top five items to remember when submitting your responses to them to avoid further questions.
CD/Recorded
$0
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Recorded/CD
Current Regulatory Requirements for Sterile Products

Current Regulatory Requirements for Sterile Products

  • Speaker: Kenneth Christie
  • Product ID: 703672
  • Duration:
This webinar will highlight and summarize the main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the expectations for protocols used to document the qualification of associated equipment, utilities and processes, and recently cited regulatory deficiencies.
CD/Recorded
$0
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Recorded/CD
The Regulatory Expectations for Environmental Monitoring Programs

The Regulatory Expectations for Environmental Monitoring Programs

  • Speaker: Kenneth Christie
  • Product ID: 703648
  • Duration:
Understand the importance of an effective environmental monitoring (EM) program and its place in your organization. This course will provide insights on regulatory requirements governing EM programs, contamination control practices, and common deficiencies cited by regulatory auditors when auditing EM programs.
CD/Recorded
$0
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Recorded/CD
Challenges of an Effective Change Control Program

Challenges of an Effective Change Control Program

  • Speaker: Kenneth Christie
  • Product ID: 704638
  • Duration:
This training program will provide attendees with a better understanding of current Quality System Regulations (QSR) require companies to maintain qualified equipment, utilities and facilities in a state of control. When changes are made to these items, the change must be documented, explained as to what will be done and the items that may be impacted. This webinar will also highlight what is expected, what to include in procedures and address the challenges faced by industry in trying to establish an effective and manageable program.
CD/Recorded
$0
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Recorded/CD
Basic Requirements for IQ, OQ and PQ Protocols

Basic Requirements for IQ, OQ and PQ Protocols

  • Speaker: Kenneth Christie
  • Product ID: 704591
  • Duration:
This training program will provide an outline of the typical protocols used for documentation of qualification activities, the type of information normally included in each and the common deficiencies cited when audited. It will highlight the importance of establishing specifications for all test challenges, proper documentation with regards to results obtained, how to address deviations encountered and how best to summarize results obtained.
CD/Recorded
$0
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Recorded/CD
4-Hr Virtual Training: Ten Steps to Data Integrity in Pharmaceutical and Biotech Labs

4-Hr Virtual Training: Ten Steps to Data Integrity in Pharmaceutical and Biotech Labs

  • Speaker: Nanda Subbarao
  • Product ID: 704730
  • Duration:
This training program will provide an introduction to regulatory expectations for data integrity, discuss generation, review and archiving of data, enumerate evolving requirements for eData, and expound on support systems for data integrity.
CD/Recorded
$0
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Recorded/CD
Annual Analytical Laboratory Data Integrity Training

Annual Analytical Laboratory Data Integrity Training

  • Speaker: Nanda Subbarao
  • Product ID: 705326
  • Duration:
This webinar will address the key elements of regulatory expectations for analytical laboratory data integrity. It will teach best practices to avoid 483s and warning letters issued by FDA related to data integrity issues.
CD/Recorded
$0
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Recorded/CD
Avoiding FDA observations: Do's and Don'ts during Laboratory Inspections

Avoiding FDA observations: Do's and Don'ts during Laboratory Inspections

  • Speaker: Kim Huynh-Ba
  • Product ID: 703278
  • Duration:
This training will provide the attendees best practices for handling FDA inspections to avoid form 483 and Warning Letters.
CD/Recorded
$0
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Recorded/CD
Key Factors to Develop an Effective CAPA System

Key Factors to Develop an Effective CAPA System

  • Speaker: Kim Huynh-Ba
  • Product ID: 703320
  • Duration:
This training will focus on the regulatory requirements for a Corrective and Preventive Actions (CAPA) system. Attendees will learn how to develop an effective CAPA system.
CD/Recorded
$0
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Recorded/CD
GMP Requirements for Validation and Re-Validation of Analytical Procedures

GMP Requirements for Validation and Re-Validation of Analytical Procedures

  • Speaker: Kim Huynh-Ba
  • Product ID: 703041
  • Duration:
This webinar will explain the cGMP and ICH validation requirements for analytical procedures and discuss key factors that would affect validation process of analytical procedures. It will review the differences between validation and re-validation plan.
CD/Recorded
$0
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Recorded/CD
Quality Metrics and the Issues with the FDA’s Revision Draft Guidance Quality Metrics Data

Quality Metrics and the Issues with the FDA’s Revision Draft Guidance Quality Metrics Data

  • Speaker: Barry A Friedman
  • Product ID: 705452
  • Duration:
This webinar will discuss the main issues with FDA’s revised draft guidance on submission of quality metrics data. It will also cover the most common observations that the FDA issues within the warning letter and how these can impact your organization.
CD/Recorded
$0
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Recorded/CD
Stability Program for Pharmaceuticals and Biologics

Stability Program for Pharmaceuticals and Biologics

  • Speaker: Nanda Subbarao
  • Product ID: 705455
  • Duration:
This webinar will provide an overview of the stability studies required for pharmaceuticals and biologics. It will also provide a summary of recent developments in the industry and regulatory requirements in this field.
CD/Recorded
$0
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Recorded/CD
Managing your GMP Quality Control (QC) Labs in Compliance with FDA Regulations

Managing your GMP Quality Control (QC) Labs in Compliance with FDA Regulations

  • Speaker: Kim Huynh-Ba
  • Product ID: 705081
  • Duration:
This webinar will discuss the common deficiencies in relation to compliance and validation issues that typically found with pharmaceutical Quality Control labs.
CD/Recorded
$0
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Recorded/CD
The New Part 11 Inspections: Requirements for Validation and SaaS/Cloud Applications

The New Part 11 Inspections: Requirements for Validation and SaaS/Cloud Applications

  • Speaker: David Nettleton
  • Product ID: 704734
  • Duration:
This training program will identify data and systems subject to Part 11 and Annex 11. It will also decode what the regulations mean and illustrate the current computer system industry standards for security, data transfer, and audit trails.
CD/Recorded
$0
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Recorded/CD
Studies to Support Temperature Excursions and Shipping of Pharmaceutical Products

Studies to Support Temperature Excursions and Shipping of Pharmaceutical Products

  • Speaker: Kim Huynh-Ba
  • Product ID: 704770
  • Duration:
Upon completion of this training program, attendees will learn key factors that would affect the shipping and distribution of drug products. One must understand the product stability profile, typical environmental conditions for storage and anticipating environmental extremes for distribution. These data will be necessary to design shipping conditions in order to maintain quality of the drug product through expiry.
CD/Recorded
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Recorded/CD
Establish an Effective Change Management Process for Stability Studies

Establish an Effective Change Management Process for Stability Studies

  • Speaker: Kim Huynh-Ba
  • Product ID: 704085
  • Duration:
Upon completion of this training program, attendees will learn key elements of a change management process, identify key indicators of change and learn the regulatory requirements for change control. This session will also discuss different observations due to the lack of effective change control program.
CD/Recorded
$0
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Recorded/CD
Annual GLP Refresher Course - 4 Hour Virtual Training

Annual GLP Refresher Course - 4 Hour Virtual Training

  • Speaker: Nanda Subbarao
  • Product ID: 704893
  • Duration:
An Annual GLP training is a requirement for all personnel involved in Good Laboratory Practices (GLP) studies. The webinar course serves both as an initial training for new employees, new to GLP concepts will serving as a refresher course for experienced senior employees. The webinar provides an overview of the GLP to remind the attendees of the regulatory requirements for organizations in which bioanalytical testing is conducted.
CD/Recorded
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Recorded/CD
21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s

21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s

  • Speaker: David Nettleton
  • Product ID: 704533
  • Duration:
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
CD/Recorded
$0
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