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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
Using Risk Analysis to Optimize Product Development and Manufacturing

Using Risk Analysis to Optimize Product Development and Manufacturing

  • Speaker: Robert DiNitto
  • Product ID: 700166
  • Duration: 60 Min
This Risk Analysis training guide you through the methodologies of and distinctions between Hazard Analyses, dFMEAs, and pFMEAs and step beyond performing Risk Analyses and documenting mitigations to the practical and proactive application. Did you know that you can use your existing Risk Analyses to help you do more than manage risk? Risk Analyses can be used to prioritize and streamline Design Input, Design Output, Design V&V, and both Pre-Production.
CD/Recorded
$249
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Recorded/CD
10 Steps to Effective Risk Analysis for US FDA and ISO 14971 Compliance

10 Steps to Effective Risk Analysis for US FDA and ISO 14971 Compliance

  • Speaker: John E Lincoln
  • Product ID: 700125
  • Duration: 60 Min
This Risk Analysis training will be helped to see how to develop a compliant Hazard Analysis/Risk Management File and Report, as outlined in ISO 14971:2001, a standard recognized by the FDA and rapidly being adopted by industry.
CD/Recorded
$249
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Recorded/CD
Use Risk Assessment to Reduce Validation Time for 21 CFR Part 11

Use Risk Assessment to Reduce Validation Time for 21 CFR Part 11

  • Speaker: David Nettleton
  • Product ID: 701584
  • Duration:
Get a detailed understanding of how to perform risk assessment as part of the 10-step risk based approach to CSV.
CD/Recorded
$0
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Recorded/CD
Cyber Security : Dealing with Cyber Issues in Your Business Continuity Planning

Cyber Security : Dealing with Cyber Issues in Your Business Continuity Planning

  • Speaker: Michael C Redmond
  • Product ID: 704820
  • Duration:
This webinar training will discuss how to create, test and implement an effective cyber Incident program to counter cyber threat and malware attacks. The Instructor will explain how to measure an organisation’s susceptibility to a cyber attack and will outline critical action areas in such event.
CD/Recorded
$0
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Recorded/CD
How to Establish an Effective IT Governance, Risk and Compliance (GRC) Framework - Organization and Responsibilities

How to Establish an Effective IT Governance, Risk and Compliance (GRC) Framework - Organization and Responsibilities

  • Speaker: Michael C Redmond
  • Product ID: 704991
  • Duration:
This training program will discuss how to develop a great GRC program that ensures proper governance, risk management and compliance management of all IT systems and processes that support the business operations.
CD/Recorded
$0
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Recorded/CD
Auditing Business Continuity Plans According to ISO 22301

Auditing Business Continuity Plans According to ISO 22301

  • Speaker: Michael C Redmond
  • Product ID: 704410
  • Duration:

This training will cover the best practices for implementing and auditing a Business Continuity Plan. The speaker will discuss the lifecycle of a BCP program with specific emphasis on Risk Assessment and Business Impact Analysis, Designing a living BCP & Testing & Maintenance. The program will also detail the various standards from FFIEC to ISO. Participants will understand what’s involved in a full BCP program and have insights based upon field experience that can be applied to Internal Audit work and BCP. The session will provide you with tools that you can bring back to your company to improve upon BCP programs & ability to audit them to provide targeted recommendations.
CD/Recorded
$0
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Recorded/CD
Excursion Studies to Support Transporting and Distributing Clinical and Commercial Products

Excursion Studies to Support Transporting and Distributing Clinical and Commercial Products

  • Speaker: Kim Huynh-Ba
  • Product ID: 704421
  • Duration:
This training program will highlight the key factors that affect stability profile of pharmaceutical products. Participants will learn how to make plan for extreme environments for transporting and distributing pharmaceutical products.
CD/Recorded
$0
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Recorded/CD
10-Step Risk Based Computer System Validation for SaaS/Cloud/Local Hosting

10-Step Risk Based Computer System Validation for SaaS/Cloud/Local Hosting

  • Speaker: David Nettleton
  • Product ID: 701583
  • Duration:
Understand the 10-step risk based approach to validation, explore methods to decrease resource requirements, and learn how to make documentation more manageable and understandable.
CD/Recorded
$0
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Recorded/CD
Quality Metrics and the Issues with the FDA’s Revision Draft Guidance Quality Metrics Data

Quality Metrics and the Issues with the FDA’s Revision Draft Guidance Quality Metrics Data

  • Speaker: Barry A Friedman
  • Product ID: 705452
  • Duration:
This webinar will discuss the main issues with FDA’s revised draft guidance on submission of quality metrics data. It will also cover the most common observations that the FDA issues within the warning letter and how these can impact your organization.
CD/Recorded
$0
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Recorded/CD
Developing a Highly Effective Enterprise Risk Management Program

Developing a Highly Effective Enterprise Risk Management Program

  • Speaker: Michael C Redmond
  • Product ID: 704827
  • Duration:
This webinar highlights the importance of an effective ERM program in project management and risk assessment. Attendees will learn how to implement a viable ERM program including documenting and testing it.
CD/Recorded
$0
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Recorded/CD
21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s

21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s

  • Speaker: David Nettleton
  • Product ID: 704533
  • Duration:
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
CD/Recorded
$0
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