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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
Part 11 - Electronic Records and Electronic Signatures

Part 11 - Electronic Records and Electronic Signatures

  • Speaker: Betty Jones
  • Product ID: 700619
  • Duration: 60 Min
This Part 11 - Electronic Records webinar will provide an insider’s view FDA’s current thinking regarding the scope and application of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).
CD/Recorded
$249
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Recorded/CD
Doing Business under the North American Free Trade Agreement, Understanding NAFTA

Doing Business under the North American Free Trade Agreement, Understanding NAFTA

  • Speaker: David Ross
  • Product ID: 700496
  • Duration: 60 Min
This NAFTA webinar/training is designed for middle and upper management to help them understand these complex rules to avoid costly fines and penalties and delays in moving their products within North America.
CD/Recorded
$149
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Recorded/CD
Global Terms of Sale: Understanding Incoterms 2000

Global Terms of Sale: Understanding Incoterms 2000

  • Speaker: David Ross
  • Product ID: 700495
  • Duration: 60 Min
This module is designed for middle and upper management to help them understand the complexities and the financial impact on their international business
CD/Recorded
$149
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Recorded/CD
The In's and Out's of FLSA: Fair Labor Standards Act

The In's and Out's of FLSA: Fair Labor Standards Act

  • Speaker: Jarik E Conrad
  • Product ID: 700545
  • Duration: 60 Min
This workshop will provide an overview of FLSA and its four provisions: (1) Minimum wage; (2) Hours of work; (3) Child labor; and (4) Equal pay
CD/Recorded
$149
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Recorded/CD
New SEC Guidance on Sarbanes-Oxley Section 404

New SEC Guidance on Sarbanes-Oxley Section 404

  • Speaker: Bob Benoit
  • Product ID: 700538
  • Duration: 60 Min
This Sarbanes-Oxley Section 404 compliance training will discussed recent developments in the SEC guidance.
CD/Recorded
$149
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Recorded/CD
Applying HACCP to insure compliance

Applying HACCP to insure compliance

  • Speaker: Joyce Wilkins
  • Product ID: 700466
  • Duration: 60 Min
This HACCP training will equip the student to apply the concepts of HACCP in their food operation in a manner that is useful and effective without being unduly burdensome. Although HACCP has been around for over 40 years, it still remains the standard in designing a food safety program.
CD/Recorded
$149
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Recorded/CD
C-TPAT - Standard Operating Procedures for Security in the Supply Chain

C-TPAT - Standard Operating Procedures for Security in the Supply Chain

  • Speaker: Karma Ruiz,Charlie Hocker
  • Product ID: 700488
  • Duration: 60 Min
In this C-TPAT training we will walk you through the most effective processes we have developed and how they can be customized for your company.
CD/Recorded
$149
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Recorded/CD
C-TPAT - annual training for employees to fulfill C-TPAT requirements by CBP

C-TPAT - annual training for employees to fulfill C-TPAT requirements by CBP

  • Speaker: Karma Ruiz,Charlie Hocker
  • Product ID: 700487
  • Duration: 60 Min
This C-TPAT training will guide you on the annual training for employees to fulfill C-TPAT requirements by CBP.
CD/Recorded
$149
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Recorded/CD
Processes for 510(k) Clearances for In Vitro Diagnostic/IVD Device Products via FDA-CDRH

Processes for 510(k) Clearances for In Vitro Diagnostic/IVD Device Products via FDA-CDRH

  • Speaker: Alfredo J Quattrone
  • Product ID: 700442
  • Duration: 60 Min
This 510(k) Clearances training/webinar will provide valuable assistance to all regulated companies that need to validate their systems.
CD/Recorded
$149
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Recorded/CD
Legally Managing Employee Absenteeism

Legally Managing Employee Absenteeism

  • Speaker: Jodie-Beth Galos
  • Product ID: 700409
  • Duration: 60 Min
This HR compliance will review the critical elements of the Americans with Disabilities Act, the Family Medical Leave Act, Workers Compensation as well as other relevant state leave laws and provide solutions to managing absenteeism fairly. There are few things as disruptive to operations as unexpected absences of employees. Many organizations have come to value dependability of attendance over other employee characteristics.
CD/Recorded
$149
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Recorded/CD
Virtual SOX Compliance

Virtual SOX Compliance

  • Speaker: Bob Benoit
  • Product ID: 700405
  • Duration: 60 Min
Virtual SOX is one of the first open doors to effective and efficient sox compliance pathway. Using technology and local administrative talent we can gather backup documents, scan, upload and observe access controls. The concept of performing a Section 404 effort completely remote requires us to have a very different paradigm shift.
CD/Recorded
$199
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Recorded/CD
Parallel trade of medicinal products in the EU - Latest case law and Commission decisions

Parallel trade of medicinal products in the EU - Latest case law and Commission decisions

  • Speaker: Jose Mora,Hector Armengod
  • Product ID: 700198
  • Duration: 60 Min
This Medical device training will talk about recent developments in the European Commission’s approach towards the parallel distribution of medicines. In the past the European Commission has taken a strong stance against restrictions imposed by pharmaceutical companies on wholesalers and distributors of medicines, preventing them from parallel importing the contract products within the European Union ("EU").
CD/Recorded
$0
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Recorded/CD
Parallel Scientific Advice: How effective is the system established between the EMEA and the FDA

Parallel Scientific Advice: How effective is the system established between the EMEA and the FDA

  • Speaker: Elisabethann Wright
  • Product ID: 700262
  • Duration: 60 Min
This Pharmaceutical training examines the system its benefits and its drawbacks and how effective is the system established between the EMEA and the FDA. The authorization of medical products by the FDA is not recognized in the EU. Neither is authorization by the EMEA Recognized by the FDA.
CD/Recorded
$249
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Recorded/CD
The Revision of the Medical Devices Directive 93/42/EEC, Background, Proposal and What It Means

The Revision of the Medical Devices Directive 93/42/EEC, Background, Proposal and What It Means

  • Speaker: Trevor Lewis
  • Product ID: 700148
  • Duration: 60 Min
Key insights to the background of the revision for medical device manufacturers with products in Europe. The Medical Devices Directive 93/42/EEC (MDD) is the key European Directive for regulatory compliance and placing of a CE mark on a medical device.
CD/Recorded
$249
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Recorded/CD
ISO 27001: The risk assessment, control selection and risk treatment plan

ISO 27001: The risk assessment, control selection and risk treatment plan

  • Speaker: Alan Calder
  • Product ID: 700300
  • Duration: 60 Min
In this Quality compliance training topics will be related to the risk assessment, control selection and risk treatment plan for developing an Information Security Management system that is capable of accredited certification to ISO/IEC 27001:2005. This is a part of a series of webinars that support those considering or developing an Information Security Management system that is capable of accredited certification to ISO/IEC 27001:2005.
CD/Recorded
$0
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Recorded/CD
Internal Audit and Risk Mitigation - Effective and practical use of the COSO and COBiT methodologies

Internal Audit and Risk Mitigation - Effective and practical use of the COSO and COBiT methodologies

  • Speaker: Vic Datta
  • Product ID: 700296
  • Duration: 60 Min
This Internal audit training is to align the audit risk assessment, audit ecosystem, audit plan, and audit engagements with the larger organization’s strategy, vision, and values.
CD/Recorded
$0
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Recorded/CD
Implications of the US PATRIOT Act for international financial services agencies

Implications of the US PATRIOT Act for international financial services agencies

  • Speaker: Kenneth Barden
  • Product ID: 700248
  • Duration: 60 Min
In this Financial services training will examine the provisions of the PATRIOT Act that affect international financial institutions, along with recent regulations implementing those provisions.
CD/Recorded
$0
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Recorded/CD
ISO 27001: Relationship to other standards - ISO 17799, ISO 20000, CobiT, and the integrated management system

ISO 27001: Relationship to other standards - ISO 17799, ISO 20000, CobiT, and the integrated management system

  • Speaker: Alan Calder
  • Product ID: 700244
  • Duration: 60 Min
In this Quality compliance training comprehensive guidance on ISO/IEC 27001:2005 that will aid and assist practitioners and managers the world over.
CD/Recorded
$0
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Recorded/CD
CE Marking Medical Devices: New Approach Directives (NAD) To Consider for Full Compliance

CE Marking Medical Devices: New Approach Directives (NAD) To Consider for Full Compliance

  • Speaker: Trevor Lewis
  • Product ID: 700136
  • Duration: 60 Min
In this Medical device training will provide an explanation of what a New Approach Directive is and what they all have in common from a compliance perspective. The placing of a CE mark on a medical device implies compliance with all European "New Approach" directives that apply and typically three or four directives will have to be considered.
CD/Recorded
$249
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Recorded/CD
FDA's cGMPs for the 21st Century Initiative

FDA's cGMPs for the 21st Century Initiative

  • Speaker: Betty Jones
  • Product ID: 700156
  • Duration: 60 Min
This presentation will provide and insiders view FDA’s path to restructuring its regulatory oversight of manufacturing quality that is based on quality systems and risk management approaches In 2002, FDA announced a significant new initiative, Current Good Manufacturing Practices (cGMPs) for the 21st Century intended to modernize FDA’s regulation of pharmaceutical quality and established a new regulatory framework for manufacturing.
CD/Recorded
$249
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