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Home › Online Training ›  Regulatory Affairs

Regulatory Affairs Training - Live Webinars, Recordings & CDs

Hundreds of regulatory affairs specialists each year use ComplianceOnline courses to learn skills and get a clear understanding of specific regulatory requirements needed to succeed in their role. On this page, you will find a broad range of courses specially designed for you. Whether you work in the pharmaceutical, medical device, and equipment, biotechnology, cosmetics, research, or regulatory agencies, or within legal, marketing, and scientific consulting firms, you can get acquainted with the regulatory requirements and guidance for your industry. With the knowledge you gain, you will learn how to apply the regulations in a compliant manner into the actual materials that your company manufactures. You will be in a better position to understand the risks your organization faces. You will get a robust understanding of compliance within the scope of your duties. With the knowledge you gain, you can evaluate current practices and make improvements where necessary. Join them!
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Recorded/CD
Compliance Measures for Case Managers

Compliance Measures for Case Managers

  • Speaker: Toni Cesta
  • Product ID: 705318
  • Duration: 60 Min
This program will review the compliance issues that most greatly impact your practice such as the 2-midnight rule, the NOTICE Act, HINNs, the important message from Medicare and others. The Joint Commission is now monitoring these issues when they have deemed status from Medicare, so your compliance is critical to a good Joint Commission survey outcome. This program will help you to identify where you may have compliance practice gaps as well as how to fix them.
CD/Recorded
$0
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Recorded/CD
Measurement Uncertainty in Microbiology

Measurement Uncertainty in Microbiology

  • Speaker: Michael Brodsky
  • Product ID: 703902
  • Duration: 60 Min
This training program will discuss the concept and application of uncertainty of measurement (MU) as required by ISO/IEC Standard 17025:2005 for laboratory accreditation, from a practical microbiological perspective, using unambiguous language and useful examples.
CD/Recorded
$179
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Recorded/CD
Handling OOS Test Results and Completing Robust Investigations

Handling OOS Test Results and Completing Robust Investigations

  • Speaker: Danielle DeLucy
  • Product ID: 704351
  • Duration: 90 Min
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
CD/Recorded
$0
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Recorded/CD
Requirements for Running Clinical Trials in Pediatrics for the EU

Requirements for Running Clinical Trials in Pediatrics for the EU

  • Speaker: Laura Brown
  • Product ID: 701983
  • Duration: 60 Min
This training will cover compliance requirements for running clinical trials in pediatrics, particularly in the EU to comply with the EU ethical considerations guidance for running clinical trials in pediatrics.
CD/Recorded
$0
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Recorded/CD
Integrating COBIT with COSO and Other Frameworks

Integrating COBIT with COSO and Other Frameworks

  • Speaker: Robert Davis
  • Product ID: 702567
  • Duration: 60 Min
Dr. Davis describes important directions and core principles of selected frameworks. He also links these guidelines and principles to relevant practices. The principles outlined in this session reflect ISACA defined governance system themes: (1) meeting stakeholder needs (2) enterprise end-to-end coverage, (3) organizational customization (4) dynamic homeostasis, (5) enabling a holistic approach, and (6) separating governance from management.
CD/Recorded
$149
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Recorded/CD
Patient Access of Medical Records under HIPAA - New HHS Guidance, New Focus for HIPAA Audits

Patient Access of Medical Records under HIPAA - New HHS Guidance, New Focus for HIPAA Audits

  • Speaker: Jim Sheldon-Dean
  • Product ID: 705220
  • Duration: 90 Min
This training program will provide a comprehensive look at the changes in the new access rights under HIPAA and CLIA regulations and prepare attendees for the process of incorporating the changes into how they do business in their facilities. It will also explain how the HIPAA audit and enforcement activities are now being increased and what needs to be done to survive a HIPAA audit.
CD/Recorded
$199
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Recorded/CD
Quality Control of Microbiological Media, Reagents and Test Kits

Quality Control of Microbiological Media, Reagents and Test Kits

  • Speaker: Michael Brodsky
  • Product ID: 703599
  • Duration: 60 Min
The webinar will discuss QC best practices and procedures for verifying the suitability and performance characteristics of microbiological media and reagents.
CD/Recorded
$169
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Recorded/CD
Product Stability Testing Program - Designing and Sustaining New and Existing Programs

Product Stability Testing Program - Designing and Sustaining New and Existing Programs

  • Speaker: Charity Ogunsanya
  • Product ID: 703000
  • Duration: 90 Min
This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.
CD/Recorded
$189
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Recorded/CD
Proper Execution of Annual Product Reviews

Proper Execution of Annual Product Reviews

  • Speaker: Danielle DeLucy
  • Product ID: 704993
  • Duration: 60 Min
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe.
CD/Recorded
$0
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Recorded/CD
Dealing with and Preventing Leave Abuse under FMLA, ADA and Workers' Comp

Dealing with and Preventing Leave Abuse under FMLA, ADA and Workers' Comp

  • Speaker: Janette Levey Frisch
  • Product ID: 704368
  • Duration: 120 Min
This webinar will help you get a working knowledge of how you can minimize your company’s exposure to employee abuse of family and medical leave – be it under the FMLA, ADA, or workers’ comp or other applicable family and medical leave laws.
CD/Recorded
$189
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Recorded/CD
The U.S. Food and Drug Administration’s Regulation of Pet Food: Complying with FDA’s Rules for the Marketing and Sale of Dog and Cat Food

The U.S. Food and Drug Administration’s Regulation of Pet Food: Complying with FDA’s Rules for the Marketing and Sale of Dog and Cat Food

  • Speaker: Karl M. Nobert
  • Product ID: 702224
  • Duration: 90 Min
This webinar will provide an introduction to FDA rules governing manufacturing, testing, labeling and marketing of pet food in the U.S. In addition to facility inspections and product recalls, the webinar will summarize and assess FDA’s enforcement activity in the U.S. pet food market paying particular attention to enforcement trends and risks.
CD/Recorded
$399
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Recorded/CD
ICD-10-CM 101, the A, B, Cs and 1, 2, 3s

ICD-10-CM 101, the A, B, Cs and 1, 2, 3s

  • Speaker: Victoria M Hernandez
  • Product ID: 703016
  • Duration: 60 Min
This healthcare coding webinar will provide an overview of ICD-10-CM, the format and guidelines. It will also explain the differences between ICD-9 and ICD-10 to help you understand how it will affect your work and as well as your co-workers and providers.
CD/Recorded
$299
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Recorded/CD
Unemployment Insurance: Critical Issues in 2021

Unemployment Insurance: Critical Issues in 2021

  • Speaker: Ronald Adler
  • Product ID: 703880
  • Duration: 90 Min
The webinar will provide an update of key federal and state unemployment issues. Participants will gain an understanding of the critical issues affecting their individual Unemployment Insurance (UI) accounts and develop methods to control UI costs and manage other related liabilities.
CD/Recorded
$349
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Recorded/CD
Veterinary Medical Devices and FDA’s Regulatory Oversight

Veterinary Medical Devices and FDA’s Regulatory Oversight

  • Speaker: Karl M. Nobert
  • Product ID: 703769
  • Duration: 60 Min
This webinar will make your understand regulatory requirements of veterinary medical device. How to differentiate regulations of human and veterinary medical devices, manufacturing requirements, safety standards, labelling requirements, how to draft the SOPs covering material intake, production, quality control, packing, distribution and sales.
CD/Recorded
$179
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Recorded/CD
HR Audits: Identifying and Managing What Happens Next as the Result of Pandemic

HR Audits: Identifying and Managing What Happens Next as the Result of Pandemic

  • Speaker: Ronald Adler
  • Product ID: 703882
  • Duration: 90 Min
This HR Audit webinar will cover key strategic, operational, and compliance HR management issues. The objective is to provide the attendee with the key areas that should be addressed in conducting an HR audit, an understanding of critical tasks to be completed, and an update how federal and state employment laws may affect the scope and the reporting of the HR audit.
CD/Recorded
$249
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Recorded/CD
An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use

An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use

  • Speaker: Karl M. Nobert
  • Product ID: 701927
  • Duration: 90 Min
This webinar will review FDA's regulatory oversight of stem cell-based products when used in humans and analyze its potential impact on the industry in the future. Learn FDA's criteria for marketing and promotion of stem cell-based products for therapeutic application.
CD/Recorded
$0
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Recorded/CD
Employee Handbooks: Key issues Post Pandemic

Employee Handbooks: Key issues Post Pandemic

  • Speaker: Ronald Adler
  • Product ID: 703910
  • Duration: 90 Min
This webinar discusses the key employment policies that should be incorporated in every employee handbook. The webinar further identifies policies statements that add value to the employer-employee relationship and discusses key issues that will require inclusion in the future.
CD/Recorded
$0
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Recorded/CD
Implementation and Management of GMP Data Integrity

Implementation and Management of GMP Data Integrity

  • Speaker: Danielle DeLucy
  • Product ID: 705029
  • Duration: 90 Min
Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.
CD/Recorded
$179
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Recorded/CD
Introduction to Root Cause Investigation for CAPA

Introduction to Root Cause Investigation for CAPA

  • Speaker: Vanessa Lopez
  • Product ID: 704409
  • Duration: 60 Min
This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.
CD/Recorded
$0
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Recorded/CD
Supplier and Service Provider Controls: FDA Expectations

Supplier and Service Provider Controls: FDA Expectations

  • Speaker: Vanessa Lopez
  • Product ID: 704844
  • Duration: 120 Min
This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should address.
CD/Recorded
$0
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