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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
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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Recorded/CD
IT Governance and Controls for FDA & SOX compliance: The single solution

IT Governance and Controls for FDA & SOX compliance: The single solution

  • Speaker: James Robertson
  • Product ID: 700188
  • Duration: 60 Min
How a common COBIT-based IT control solution can satisfy multiple regulatory and business requirements. This seminar will show you that a common IT control solution should be available to satisfy multiple regulatory and business requirements.
CD/Recorded
$249
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Recorded/CD
Service Providers and SAS 70 Reports Understanding Requirements, Compliance and Benefits

Service Providers and SAS 70 Reports Understanding Requirements, Compliance and Benefits

  • Speaker: Alyssa Martin
  • Product ID: 700189
  • Duration: 60 Min
This SAS 70 training will provide a Process of SAS 70 Audit, frequency & formatting of documenting controls in COSO and COBIT and SAS 70 Report types and impact of Sarbanes-Oxley to create the demand for SAS 70 audits.
CD/Recorded
$249
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Recorded/CD
Radiation Dose Setting - Method 1

Radiation Dose Setting - Method 1

  • Speaker: Joyce Hansen
  • Product ID: 700119
  • Duration: 60 Min
The steps for conducting Method 1 and identifying typical issues that might arise when conducting the test method. This presentation is the first of three presentations on the methodologies for the determiniation of the minimum sterilization dose.
CD/Recorded
$249
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Recorded/CD
A Review of Sarbanes-Oxley's Impact on IT in Year Three

A Review of Sarbanes-Oxley's Impact on IT in Year Three

  • Speaker: George Spafford
  • Product ID: 700111
  • Duration: 60 Min
This SOX compliance training will benefit public companies who are either embarking on their Sarbanes-Oxley compliance journey or are struggling with sustaining their current control environment.
CD/Recorded
$249
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Recorded/CD
Leveraging best-practice frameworks to simplify regulatory compliance

Leveraging best-practice frameworks to simplify regulatory compliance

  • Speaker: Alan Calder
  • Product ID: 700102
  • Duration: 60 Min
This regulatory compliance training will help in frame working and Leveraging best-practices in the way of the business in a cost effective manner. Organizations face complex and rapidly evolving regulatory requirements, which have to be met within an equally fast-changing information threat environment.
CD/Recorded
$249
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Recorded/CD
Reduce the cost of Sarbanes Oxley Compliance using Control Automation

Reduce the cost of Sarbanes Oxley Compliance using Control Automation

  • Speaker: Arthur Stewart
  • Product ID: 700068
  • Duration: 60 Min
This Sarbanes Oxley Compliance (SOX) training is targeted at compliance and risk managers who are looking to leverage leading technology to increase quality and reduce the costs of compliance and process management.
CD/Recorded
$199
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Recorded/CD
Impact of Recent Immigration Developments on Employers

Impact of Recent Immigration Developments on Employers

  • Speaker: Sameer Khedekar
  • Product ID: 705344
  • Duration:
Recent changes impact not only the employment of foreign nationals, but the broader workforce comprised of green card holders and international travelers. Executive leadership is looking to compliance officers, legal departments and human resources to understand how these changes affect their company. Tune in to learn how to ensure your business is not adversely affected by changes in immigration legislation and policy.
CD/Recorded
$0
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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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