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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
Life Cycle Risk Management for 21 CFR 820 and ISO 13485

Life Cycle Risk Management for 21 CFR 820 and ISO 13485

  • Speaker: Russell Pizzuto
  • Product ID: 704964
  • Duration: 90 Min
This webinar will present a Lifecycle Risk Management System that meets FDA and ISO requirements. That risk management system (based on ISO 14971) creates a closed loop system that identifies risks, and uses field use feedback to adjust risks and to improve designs and processes. The objective evidence produced by a Lifecycle Risk Management Systems can be used to demonstrate risk management compliance to 21 CFR Part 820 and ISO 13485.
CD/Recorded
$0
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Recorded/CD
Protecting Your Business from ACH Fraud | Developing the Internal Controls

Protecting Your Business from ACH Fraud | Developing the Internal Controls

  • Speaker: Rayleen M Pirnie
  • Product ID: 704921
  • Duration: 90 Min
This webinar training will help you identify common ACH frauds. The instructor will discuss the sound business practices and easy to implement internal controls proven to reduce losses and how to review common financial institution offered solutions to further minimize exposure.
CD/Recorded
$179
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Recorded/CD
Submitting FDA Electronic Regulatory Filings - Drug Establishment Registrations and Drug Listings

Submitting FDA Electronic Regulatory Filings - Drug Establishment Registrations and Drug Listings

  • Speaker: Camille Davis Thornton
  • Product ID: 703234
  • Duration: 60 Min
This webinar on FDA electronic filings will discuss and provide clarification on the process of submitting drug establishment registration and drug listing information to the FDA using its Electronic Submission Gateway (ESG).
CD/Recorded
$249
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Recorded/CD
Legal HR Documentation - What You Need to Know

Legal HR Documentation - What You Need to Know

  • Speaker: Susan Fahey Desmond
  • Product ID: 704960
  • Duration: 90 Min
Documentation could be your best defense against a lawsuit. If you do it wrong, or if you destroy documentation too early, it could mean trouble. This training program will guide you on how to document clearly to avoid expensive litigation.
CD/Recorded
$229
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Recorded/CD
Integrating Pharmacovigilance and Technical Complaint Systems

Integrating Pharmacovigilance and Technical Complaint Systems

  • Speaker: David L Chesney
  • Product ID: 704956
  • Duration: 90 Min
This webinar will discuss the FDA requirements for pharmacovigilance and complaint evaluation under GMP
CD/Recorded
$0
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Recorded/CD
OSHA Outreach Overview | What, Who, When & Why

OSHA Outreach Overview | What, Who, When & Why

  • Speaker: Michael Aust
  • Product ID: 704957
  • Duration: 60 Min
This webinar will discuss the benefits of employers introducing the OSHA Outreach Program into their workplace. Participants will learn the significance of the program and help to improve your safety culture, reduce the number of workplace incidents and injuries and reduce workers’ compensation cost.
CD/Recorded
$0
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Recorded/CD
FDA & CFIA 2016 Regulatory Changes/Updates Since ACE | Make Sure Your Business is Updated

FDA & CFIA 2016 Regulatory Changes/Updates Since ACE | Make Sure Your Business is Updated

  • Speaker: Grant Smith
  • Product ID: 704621
  • Duration: 90 Min
This training program will cover the 2016 regulatory changes and updates for the FDA (US Food and Drug Administration) and the CFIA (Canadian Food Inspection Agency). The program will also discuss updated product code classifications, license requirements for SFCA/CFIA, Automated Import Reference System updates and latest product marking requirements.
CD/Recorded
$199
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Recorded/CD
2016 HIPAA Changes

2016 HIPAA Changes

  • Speaker: Laura S Hargraves
  • Product ID: 703952
  • Duration: 60 Min
This training program will discuss HIPAA Omnibus updates for 2016 and highlight court cases that have changed the landscape of HIPAA. It will further detail the increased burden on business associates as well.
CD/Recorded
$149
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Recorded/CD
Fringe Benefits: Section 132 and Beyond

Fringe Benefits: Section 132 and Beyond

  • Speaker: Vicki M. Lambert
  • Product ID: 704942
  • Duration: 90 Min
In this webinar we will discuss how to handle correctly all fringe benefits including the simple ones in order minimize the chance for penalties and interest to be levied against your company or for triggering larger and more intrusive governmental audits.
CD/Recorded
$0
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Recorded/CD
Device Design and Risk Management

Device Design and Risk Management

  • Speaker: Daniel O Leary
  • Product ID: 704561
  • Duration: 90 Min
As medical device requirements and expectations increase, coupled with strengthened standards, the design project must seek every opportunity to leverage activities in the area to satisfy requirements in other areas. This reduces the total work and helps make these processes more efficient. By attending this presentation, you will learn techniques to improve your device design project.
CD/Recorded
$0
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Recorded/CD
Harmonized Tariff Schedule (HTS) 2017 | Scope of the Amendment

Harmonized Tariff Schedule (HTS) 2017 | Scope of the Amendment

  • Speaker: Linda B Sarabia
  • Product ID: 704672
  • Duration: 60 Min
This webinar will prepare attendees on the new sets of amendments recommended by the World Customs Organization to the Harmonized Tariff Schedule effective January 1, 2017. Participants will understand the rules to classify products under HTS. Instructor will discuss practical application of certificates of origin, considerations under amendments and how it will affect trade in various industries.
CD/Recorded
$199
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Recorded/CD
Cuba Sanctions: Understanding Policy Changes and Potential Opportunities

Cuba Sanctions: Understanding Policy Changes and Potential Opportunities

  • Speaker: Suzanne Bullitt
  • Product ID: 704297
  • Duration: 60 Min
This webinar training will focus on policy changes and the opportunities for business development and growth in Cuba. The US Department of Treasury, Office of Foreign Assets Control (OFAC) and the US Department of Commerce, Bureau of Industry and Security (BIS) respectively amended the Cuban Assets Control Regulations (CACR) and the Export Administration Regulations (EAR) to further ease the US embargo against Cuba and authorize certain business activities with Cuba in targeted sectors. This training will focus on these areas of change.
CD/Recorded
$199
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Recorded/CD
Defining and Managing Protocol Deviation/Violation/Exception

Defining and Managing Protocol Deviation/Violation/Exception

  • Speaker: Calin Popa
  • Product ID: 704953
  • Duration: 90 Min
This webinar will teach you how to downsize the risk of noncompliance during the development of a clinical trial by helping you to understand, correct and prevent potential protocol deviations/violations.
CD/Recorded
$0
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Recorded/CD
Understanding HIPAA Compliance Program Requirements

Understanding HIPAA Compliance Program Requirements

  • Speaker: Jay Hodes
  • Product ID: 703975
  • Duration: 60 Min
This HIPAA training program will address questions pertaining to HIPAA requirements, HIPAA Security and Privacy Rules, HIPAA compliance programs, HIPAA risk management plans, HIPAA training requirements, and more.
CD/Recorded
$179
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Recorded/CD
Challenging your existing Payroll Disaster Plan

Challenging your existing Payroll Disaster Plan

  • Speaker: Vicki M. Lambert
  • Product ID: 704868
  • Duration: 90 Min
In this webinar we will discuss in-depth what is required for the payroll department to continue operating properly during disaster situations. We will provide guidelines for creating a disaster program, identify critical elements necessary for a successful program and provide sample charts explaining critical functions.
CD/Recorded
$229
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Recorded/CD
Executive Exposure under Strict Liability Doctrine in FDA Enforcement

Executive Exposure under Strict Liability Doctrine in FDA Enforcement

  • Speaker: David L Chesney
  • Product ID: 704951
  • Duration: 90 Min
This webinar will discuss the FDA requirements for the involvement of the executive level in compliance governance. It will also discuss two major Supreme Court cases relied upon by the FDA to support their position on strict liability. Attendees will gain an understanding of the FDA policy and steps you can take to mitigate its impact.
CD/Recorded
$279
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Recorded/CD
FCPA and Anti-Bribery Cases and Trends in the US, China and Russia

FCPA and Anti-Bribery Cases and Trends in the US, China and Russia

  • Speaker: Grant Smith
  • Product ID: 704332
  • Duration: 60 Min
This training program will highlight the practices prohibited by the FCPA. It will help determine if your current travel and entertainment policy is in compliance and discuss what accounting and anti-bribery violations are covered.
CD/Recorded
$50
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Recorded/CD
How to Handle the Taxation When Feeding, Housing and Educating Your Employees

How to Handle the Taxation When Feeding, Housing and Educating Your Employees

  • Speaker: Vicki M. Lambert
  • Product ID: 704941
  • Duration: 90 Min
In this webinar we will discuss the requirements of the Internal Revenue Code as it relates to certain fringe benefits including relocation, meals and educational assistance. The instructor will provide guidance on how these benefits should or should not be taxed and/or reported.
CD/Recorded
$249
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Recorded/CD
Red Flags of Internal Fraud, Asset Misappropriation, and Corruption

Red Flags of Internal Fraud, Asset Misappropriation, and Corruption

  • Speaker: H. David Kotz
  • Product ID: 704865
  • Duration: 75 Min
This webinar highlights how one can identify red flags of frauds, asset misappropriation and corruption. Presented by the former Inspector General of the SEC, the webinar provides specific and concrete tips to identify potential red flags before there is significant exposure.
CD/Recorded
$249
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Recorded/CD
State Insurance Solvency Modernization Initiatives - Financial Crisis to Present

State Insurance Solvency Modernization Initiatives - Financial Crisis to Present

  • Speaker: Adam Kerns
  • Product ID: 704901
  • Duration: 60 Min
This webinar training will discuss the state insurance regulatory developments from 2008 through today regarding the (NAIC) Solvency Modernization Initiative (SMI). Participants who attend this webinar will receive a comprehensive, in-depth review of the various state insurance solvency modernization initiatives, along with a better understanding of how such initiatives will directly impact their daily operations.
CD/Recorded
$0
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