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
Audits - Seven reasons they don't work

Audits - Seven reasons they don't work

  • Speaker: Susanne Manz
  • Product ID: 705042
  • Duration: 90 Min
Continuous Improvement starts with awareness of issues and opportunities. And without an effective internal audit program, management lacks awareness of the issues within their quality system. Management is blind to the gaps in the quality system and the risk that poses for the company. Even worse, management is blind to the impact on product quality and risk to the customer. This webinar will highlight red-flags and ways reduce compliance and quality risk.
CD/Recorded
$0
Recorded/CD
Phase I First-in-Man Studies: What is Special About How and Where These Trials are Conducted?

Phase I First-in-Man Studies: What is Special About How and Where These Trials are Conducted?

  • Speaker: Charles H Pierce
  • Product ID: 704842
  • Duration: 90 Min
This webinar will discuss the expectations of Phase 1 'First-in-Man' clinical studies, contrast the testing of pharmacokinetics and pharmacodynamics, differentiate safety testing in Phase 1 and 3 and describe the process of establishing the starting dose.
CD/Recorded
$50
Recorded/CD
Perceptions of The Health Risks of Cosmetics, and What it means to Their Regulation

Perceptions of The Health Risks of Cosmetics, and What it means to Their Regulation

  • Speaker: Rob Ross Fichtner
  • Product ID: 704955
  • Duration: 90 Min
This webinar will discuss some of the major issues in the regulation of cosmetics. Upon completion of the session attendees will learn how regulators regulate cosmetics compared to other categories, fine line between cosmetics and drugs, and future directions for cosmetic regulations.
CD/Recorded
$179
Recorded/CD
How the Food Safety Modernization Act Affects USDA Regulated Facilities

How the Food Safety Modernization Act Affects USDA Regulated Facilities

  • Speaker: Derrick Swint
  • Product ID: 705032
  • Duration: 90 Min
This FSMA webinar will outline key objectives for the meat and poultry industry to better understand what steps must be taken by food producers in this sector to meet, and preferably exceed, all relevant standards and regulations of the Food Safety Modernization Act (FSMA).
CD/Recorded
$0
Recorded/CD
Basic Concepts of Sterility Assurance

Basic Concepts of Sterility Assurance

  • Speaker: Mark Seybold
  • Product ID: 705046
  • Duration: 90 Min
This course will provide a foundation for developing your technical skills related to sterility assurance.
CD/Recorded
$0
Recorded/CD
Designing an Effective and Compliant Standard Operating Procedure (SOP) and Standard Test Method (STM)

Designing an Effective and Compliant Standard Operating Procedure (SOP) and Standard Test Method (STM)

  • Speaker: Charity Ogunsanya
  • Product ID: 705018
  • Duration: 90 Min
This webinar training will benefit manufacturers of manufactured products to achieve an effective, robust and compliant SOP and STM which will result in a cost effective and efficient manufacturing and testing of products. A well planned and written SOP or STM will reduce the incidence of out-of-specification (OOS) results, failure, product non-conformances, deviation and invalid assay investigations.
CD/Recorded
$0
Recorded/CD
Compliance with the New EU Clinical Trial Regulation

Compliance with the New EU Clinical Trial Regulation

  • Speaker: Laura Brown
  • Product ID: 705007
  • Duration: 60 Min
This webinar will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU.
CD/Recorded
$0
Recorded/CD
Applying Statistical Process Control Effectively

Applying Statistical Process Control Effectively

  • Speaker: Steven Wachs
  • Product ID: 701994
  • Duration: 60 Min
This training will help you gain a solid understanding of what Statistical Process Control (SPC) is and what it isn’t. We will discuss the common misunderstanding and misapplications of SPC so that you may avoid them.
CD/Recorded
$229
Recorded/CD
Project Risk Management

Project Risk Management

  • Speaker: Mario Mosse
  • Product ID: 705015
  • Duration: 90 Min
Project risk management includes the processes of conducting risk management planning, identification, analysis, action planning, and controlling risk on a project. This training program will analyze the objectives of project risk management - to increase the likelihood and impact of positive outcomes while decreasing the likelihood and impact of negative events affecting the success of the project.
CD/Recorded
$229
Recorded/CD
Metrics and Dashboards for Quality and Compliance

Metrics and Dashboards for Quality and Compliance

  • Speaker: Susanne Manz
  • Product ID: 703928
  • Duration: 90 Min
This training program will discuss the challenges faced by medical device companies amid close scrutiny by industry regulators. It will also offer best practices for combating lack of transparency in quality/compliance data.
CD/Recorded
$50
Recorded/CD
Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?

Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?

  • Speaker: Henry Urbach
  • Product ID: 703058
  • Duration: 90 Min
This webinar on biopharmaceutical raw material testing will discuss how to implement processes for the control of microbial contamination, establish microbial limits and mitigate the risk of contamination.
CD/Recorded
$199
Recorded/CD
Effective Deviation Investigators Under GMP

Effective Deviation Investigators Under GMP

  • Speaker: David L Chesney
  • Product ID: 704974
  • Duration: 120 Min
This 120 minute training course will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.
CD/Recorded
$299
Recorded/CD
Navigating the variations in state food regulatory structure

Navigating the variations in state food regulatory structure

  • Speaker: Darin Detwiler
  • Product ID: 705006
  • Duration: 90 Min
This course is designed to bring food industry leaders up to speed with the latest research in states’ food regulatory characteristics. The goal is to enable industry leaders to better understand and navigate through the state-by-state nuances.
CD/Recorded
$0
Recorded/CD
Project Management Essentials: The 8 Keys to Successfully Completing Every Project On-Time and On Budget

Project Management Essentials: The 8 Keys to Successfully Completing Every Project On-Time and On Budget

  • Speaker: Christopher R DeVany
  • Product ID: 705013
  • Duration: 90 Min
This training program will help attendees grasp the essentials of project management and plan effectively for identifying project needs. It will also discuss practices for keeping content, process, and structure on track to produce positive outcomes.
CD/Recorded
$0
Recorded/CD
Compliance with the New ICH GCP revised 2 Guidelines

Compliance with the New ICH GCP revised 2 Guidelines

  • Speaker: Laura Brown
  • Product ID: 704989
  • Duration: 60 Min
This New ICH GCP E6 Revision 2 changes will cover those new requirements for running clinical trials, evaluate the changes and discuss how to implement these for sponsors, CROs and study sites. This session will enable you to meet the new international GCP standard to ensure the acceptance of clinical trial data by the regulatory authorities internationally including the European Union (EU), Japan, the United States, Canada and Switzerland.
CD/Recorded
$0
Recorded/CD
Understanding the Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program

Understanding the Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program

  • Speaker: Charity Ogunsanya
  • Product ID: 705008
  • Duration: 90 Min
This webinar will help the attendee gain an understanding of the requirements of current USP <85> Bacterial Endotoxin Test (BET), European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia (General Tests, No. 4.01). The webinar will provide the attendee the ability to understand the different LAL testing methodologies, choosing the best test method applicable to the product type, criticality of the BET test result as it applies to the release of a cGMP manufactured product.
CD/Recorded
$0
Recorded/CD
Data Analysis in QSR

Data Analysis in QSR

  • Speaker: Daniel O Leary
  • Product ID: 704990
  • Duration: 90 Min
Data analysis is one of the most powerful improvement tools because it can lead to cost reductions and preventive action. To use these techniques you need to know both the regulatory requirements and the analysis framework. This webinar gives you the tools and techniques to implement an effective data analysis program.
CD/Recorded
$0
Recorded/CD
Russia: Compliance Processes and Regulations

Russia: Compliance Processes and Regulations

  • Speaker: Robert J Russell
  • Product ID: 703870
  • Duration: 90 Min
This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.
CD/Recorded
$249
Recorded/CD
You Found an Objectionable Microorganism, Now What? Risk of presence of Objectionable Microorganisms in Biopharmaceuticals

You Found an Objectionable Microorganism, Now What? Risk of presence of Objectionable Microorganisms in Biopharmaceuticals

  • Speaker: Henry Urbach
  • Product ID: 702964
  • Duration: 60 Min
This webinar on objectionable microorganisms will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.
CD/Recorded
$229
Recorded/CD
Selection and Management of Contract Vendors

Selection and Management of Contract Vendors

  • Speaker: Peggy Berry
  • Product ID: 704884
  • Duration: 90 Min
This webinar will discuss approaches to selecting vendors to perform manufacturing and testing activities as well as clinical study activities. The information obtained will enable implementation of an effective vendor selection program and a comprehensive vendor management and oversight program. The webinar will address aspects of requesting bids, performing audits, evaluating risks, and preparing plans and agreements for effective oversight and management.
CD/Recorded
$0
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