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Home › Online Training ›  Risk Management & Controls

Risk Management and Controls Regulatory Compliance Training - Live Webinars, Recordings & CDs

The risk management courses on this page are designed to help you strengthen your professional profile and add value to your organization. These courses will help you get insights associated with the numerous laws pertaining to risk management. You will learn how to manage business risks such as developing risks around competition, operational strategies, vendor risk management, establishing meaningful metrics, avoiding decision-making errors, and much more.
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Recorded/CD
Medical Device Software Risk Analysis

Medical Device Software Risk Analysis

  • Speaker: Edwin L Bills
  • Product ID: 700902
  • Duration: 60 Min
This webinar discusses the use of risk analysis techniques applied to medical device software including discussions of pitfalls in the process of risk analysis. This webinar will provide guidance to medical device companies that need to perform risk analysis on their software products and internal systems.
CD/Recorded
$249
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Recorded/CD
Risk-Based Software V&V - FDA,GAMP®, 14971

Risk-Based Software V&V - FDA,GAMP®, 14971

  • Speaker: John E Lincoln
  • Product ID: 700814
  • Duration: 90 Min
This risk-based software V&V training will guide you through 11 "must have" elements of software validation and how to use your Risk Management Tools (per ISO 14971:2007).
CD/Recorded
$299
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Recorded/CD
Hazard Analysis & Risk Management - New 14971

Hazard Analysis & Risk Management - New 14971

  • Speaker: John E Lincoln
  • Product ID: 700813
  • Duration: 90 Min
Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report. The US FDA is increasingly stating that many regulated activities should be "risk-based". Major resource-consuming activities such as product and process / equipment / facility, and software validation, CAPA investigations, vendor audits can all be tailored to a risk based approach.
CD/Recorded
$249
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Recorded/CD
Writing Effective Suspicious Activity Reports

Writing Effective Suspicious Activity Reports

  • Speaker: Kenneth Barden
  • Product ID: 700482
  • Duration: 60 Min
The keystone of AML compliance is the reporting to proper authorities of those transactions and activities considered to be suspicious
CD/Recorded
$149
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Recorded/CD
Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends

Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends

  • Speaker: David Dills
  • Product ID: 700746
  • Duration: 60 Min
Learn how to use and how far to go with an effective and efficient approach for your CAPA investigation. This webinar will provide valuable assistance and guidance to all regulated companies that are preparing to use or are currently using risk-based tools for CAPA investigations and closing out investigations in a timely manner.
CD/Recorded
$249
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Recorded/CD
Practical tips to comply and implement the Adverse Event Reporting requirement of the new Dietary Supplement and Nonprescription Drug Consumer Protection Act

Practical tips to comply and implement the Adverse Event Reporting requirement of the new Dietary Supplement and Nonprescription Drug Consumer Protection Act

  • Speaker: Ashish Talati
  • Product ID: 700754
  • Duration: 60 Min
The Webinar discusses recordkeeping requirements of serious and non-serious adverse events reported to a dietary supplement manufacturer, packer, or distributor. The Dietary Supplement and Nonprescription Drug Consumer Protection Act law mandates reporting to the Food and Drug Administration (FDA) of serious adverse events for dietary supplements.
CD/Recorded
$249
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Recorded/CD
Conducting and Documenting Proper Risk Analysis In compliance with ISO 14971

Conducting and Documenting Proper Risk Analysis In compliance with ISO 14971

  • Speaker: Edwin L Bills
  • Product ID: 700713
  • Duration: 60 Min
The presentation will review the complete requirements for Risk Analysis and give an example of how a company can easily create a Risk Analysis in full compliance with the standard. The information will assist in meeting various national and global regulatory requirements for medical devices.
CD/Recorded
$149
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Recorded/CD
ISO 14971:2007 -- The Newly Revised Risk Management Standard for Medical Products

ISO 14971:2007 -- The Newly Revised Risk Management Standard for Medical Products

  • Speaker: John E Lincoln
  • Product ID: 700708
  • Duration: 60 Min
An overview of the new ISO 14971:2007 standard with emphasis on changes from the 2001 version. Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in ISO 14971:2007, a standard recognized by the FDA and rapidly being adopted by industry.
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: 700620
  • Duration: 60 Min
This FDA’s cGMPs training/webinar will provide and insider’s view FDA’s path to restructuring its regulatory oversight of manufacturing quality that is based on quality systems and risk management approaches.
CD/Recorded
$249
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Recorded/CD
The New Dietary Supplement Good Manufacturing Practices

The New Dietary Supplement Good Manufacturing Practices

  • Speaker: John Suzuki
  • Product ID: 700642
  • Duration: 60 Min
This New Dietary supplements webinar will highlight from a quality perspective the introductory requirements of these new CGMP regulations and examine methods and strategies for meeting these new requirements.
CD/Recorded
$299
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Recorded/CD
Risk Management - Beyond the Numbers

Risk Management - Beyond the Numbers

  • Speaker: Roger Greenwald
  • Product ID: 700624
  • Duration: 60 Min
This Risk Management webinar/training will describe enhancements to these techniques that can improve your relationships with customers and regulatory agencies, resulting in a reduced number of surprises during inspections.
CD/Recorded
$249
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Recorded/CD
Quality & Finance: Creating a Balance Using Lean Principles

Quality & Finance: Creating a Balance Using Lean Principles

  • Speaker: Tom Zidel
  • Product ID: 700551
  • Duration: 60 Min
This healthcare webinar will give an introduction to lean in healthcare which includes an illustrative exercise to aid participants in understanding the basic underlying concept of lean.
CD/Recorded
$249
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Recorded/CD
How to Audit Contingency and Business Continuity Plans

How to Audit Contingency and Business Continuity Plans

  • Speaker: Javier Kuong
  • Product ID: 700484
  • Duration: 60 Min
In this Audit webinar/training learn how to Audit Contingency and Business Continuity Plans and need for an effective audit of your contingency and business continuity plans. Having a contingency and business continuity plan is only half of the battle. A key issue is how does your organization know that the contingency and business continuity plan is sound and adequate for your needs? .
CD/Recorded
$249
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Recorded/CD
Internal Controls and Governance: Strategies and Controls for SOX Compliance and IT Governance for Small and Medium Business

Internal Controls and Governance: Strategies and Controls for SOX Compliance and IT Governance for Small and Medium Business

  • Speaker: Javier Kuong
  • Product ID: 700096
  • Duration: 60 Min
This Internal Controls and Governance training will guide you through Strategies and Controls for Small and Medium Business in SOX Compliance & IT Governance.
CD/Recorded
$249
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Recorded/CD
Quantitative Approach to User Requirements Risk Assessment

Quantitative Approach to User Requirements Risk Assessment

  • Speaker: Vimarie Ortiz
  • Product ID: 700390
  • Duration: 60 Min
This Risk management training offers a quantitative risk management approach you can use to measure system implementation and enhancement efforts against the criticality and business/regulatory significance of the system.
CD/Recorded
$249
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Recorded/CD
Project Manage Your Validation Project -- An Overview

Project Manage Your Validation Project -- An Overview

  • Speaker: Lawrence Mucha
  • Product ID: 700367
  • Duration: 60 Min
This Validation training will provide valuable assistance to all regulated companies that need to validate their systems. Project management is the application of knowledge, skills, tools, and techniques to manage project activities to meet project requirements
CD/Recorded
$249
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Recorded/CD
Risk Based Validation of Software and Computer Systems

Risk Based Validation of Software and Computer Systems

  • Speaker: Dr. Ludwig Huber
  • Product ID: 700339
  • Duration: 60 Min
In this Risk Based Validation training we will go through various scenarios and recommend actions for validation and other controls.
CD/Recorded
$149
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Recorded/CD
Effectively application of FMEA as a Risk Management Tool and meet ISO 13485:2003 Risk Management (ISO 14971) Requirements

Effectively application of FMEA as a Risk Management Tool and meet ISO 13485:2003 Risk Management (ISO 14971) Requirements

  • Speaker: Angelo Scangas
  • Product ID: 700329
  • Duration: 60 Min
In this Medical device training understand the expectations of FDA and the EU in applying risk analysis to medical devices. Risk Management is required by ISO 13485 and risk analysis by the FDA’s Quality System Regulations (QSR) and by of the EU medical device regulations. Using practical examples, this course look at the regulatory and reporting requirements of EN ISO 14971, "Medical devices - application of risk management to medical devices".
CD/Recorded
$299
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Recorded/CD
Internal Auditing of Risk Management: Emphasis on effectiveness and compliance to QSR, ISO 13485 and ISO 14971

Internal Auditing of Risk Management: Emphasis on effectiveness and compliance to QSR, ISO 13485 and ISO 14971

  • Speaker: Phil Smart
  • Product ID: 700272
  • Duration: 60 Min
This Internal audit training will guide on how to set up an ISO 14971 audit program with specific auditor guidelines.
CD/Recorded
$0
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Recorded/CD
Review of Changes to the New ANSI/AAMI/ISO 11137-2006 (Parts 1, 2, & 3) Sterilization of health care products - requirements for validation and routine control - Radiation Sterilization

Review of Changes to the New ANSI/AAMI/ISO 11137-2006 (Parts 1, 2, & 3) Sterilization of health care products - requirements for validation and routine control - Radiation Sterilization

  • Speaker: Lisa Foster
  • Product ID: 700174
  • Duration: 60 Min
This Radiation Sterilization training will review all the changes included in the new standard and how they will affect the device manufacturer.
CD/Recorded
$249
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